Sr Manager, Design Assurance

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    "heading": "Sr Manager, Design Assurance",
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    "description_html": "<span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>This role partners cross-functionally with R&D, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, and Program Management to drive quality-focused decision making, risk-based development practices, and efficient execution of development programs. The Senior Manager establishes and maintains Design Assurance methodologies, systems, and best practices aligned with applicable global regulatory requirements and industry standards.</span></span></span></span></span></span><br><br><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Key responsibilities include:</span></span></span></span></span></span><ul><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Establish and maintain Design Assurance processes, tools, and governance supporting compliant and efficient product development.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Provide strategic and tactical quality leadership across new product development, sustaining engineering, and design change activities.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Ensure effective implementation of Design Controls, Risk Management, Verification & Validation, usability engineering, and design transfer requirements.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Drive quality awareness, visibility, and communication across development teams to support functional and business objectives.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Develop organizational capability through coaching, mentoring, and talent development of Design Assurance personnel.</span></span></span></span></span></span></li></ul><br><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:</span></span></span></span></span></span><ul><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Lead Design Assurance activities supporting new product development, sustaining engineering, and lifecycle management activities.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Provide oversight and guidance on implementation of Design Controls in accordance with internal procedures and applicable regulatory requirements.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Lead and develop Design Assurance personnel including resource planning, hiring, performance management, mentoring, and career development.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Partner with R&D and cross-functional teams to define development strategies that incorporate quality, reliability, manufacturability, and regulatory expectations.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Provide leadership on development and execution of design verification and validation strategies, including protocol review, traceability, and objective evidence of compliance.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Ensure robust application of risk management principles throughout the product lifecycle, including hazard analysis, risk evaluation, risk controls, and benefit-risk assessments.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Guide teams in development of product requirements, design inputs/outputs, acceptance criteria, and design transfer readiness.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Review and approve key design deliverables including design plans, requirements, risk documentation, V&V documentation, DHF content, and design changes.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Drive product quality improvements through analysis of product performance, complaint trends, reliability data, and development metrics.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Facilitate root cause investigations and corrective/preventive action activities associated with design-related issues.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Collaborate with Manufacturing and Operations teams to ensure effective transfer of product designs into production and commercialization.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Champion continuous improvement initiatives to streamline product development processes while maintaining compliance.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Establish and monitor Design Assurance metrics to evaluate development effectiveness, product quality, and organizational performance.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Support internal and external audits, regulatory inspections, and responses associated with product development activities.</span></span></span></span></span></span></li></ul><div style=\"border-bottom:solid 1pt;padding:0in 0in 1pt 0in;\"><span style=\"font-size:10pt;\"><span style=\"font-family:'Times New Roman', serif;\"><b><span lang=\"en-au\" style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\">EDUCATION/EXPERIENCE:                                                           </span></span></b></span></span></div><ul><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Bachelor’s degree in Engineering or related technical discipline required; advanced degree preferred.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Minimum of 8–10 years of progressive experience in medical device Quality and/or Design Assurance roles with demonstrated leadership experience.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Minimum of 3–5 years of people leadership experience, including management of technical teams.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Demonstrated experience supporting product development and commercialization under Design Controls in regulated environments.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Strong working knowledge of applicable regulations and standards including 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR 2017/745, and IEC 60601 (where applicable).</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Experience with Design History File (DHF), risk management, verification and validation, usability engineering, and design transfer activities.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Strong understanding of statistical methods, reliability engineering principles, and root cause investigation techniques.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Demonstrated capability in cross-functional leadership, project execution, and decision making in fast-paced development environments.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Working knowledge of Lean, Six Sigma, and continuous improvement methodologies preferred.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification preferred.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Lead Auditor certification preferred.</span></span></span></span></span></span></li></ul> <div style=\"border-bottom:solid 1pt;padding:0in 0in 1pt 0in;\"><span style=\"font-size:10pt;\"><span style=\"font-family:'Times New Roman', serif;\"><b><span lang=\"en-au\" style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\">SUPERVISORY RESPONSIBILITIES                                                               </span></span></b></span></span></div> <ul><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Responsible for leadership and development of Design Assurance personnel, including engineers and people leaders where applicable.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Accountable for organizational capability, resource planning, performance management, and achievement of quality and development objectives.</span></span></span></span></span></span></li></ul><span style=\"font-size:11pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Calibri, sans-serif;\"><b><span style=\"font-family:Roboto;\"><span style=\"color:#ed8b00;\">Employee Benefits</span></span></b> <span style=\"font-size:10pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Roboto;\">include </span></span></span><span style=\"font-size:10pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Roboto;\">a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.</span></span></span></span></span></span><br><strong><span style=\"font-size:11pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Calibri, sans-serif;\"><span style=\"font-family:Roboto;\">Salary Range: $185,000 - $204,000</span></span></span></span></strong><br><span style=\"font-size:11pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Calibri, sans-serif;\"><span style=\"font-size:10pt;\"><span style=\"background:#FFFFFF;\"><span style=\"line-height:115%;\"><span style=\"font-family:Roboto;\"><span style=\"color:#202124;\">Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. </span></span></span></span></span></span></span></span><br><span style=\"font-size:11pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Calibri, sans-serif;\"><b><span style=\"font-family:Roboto;\">Join Us! </span></b><a href=\"https://imperativecare.com/careers/\" style=\"color:#0000FF;text-decoration:underline;\"><b><span style=\"font-family:Roboto;\"><span style=\"color:#ed8b00;\">Apply Today</span></span></b></a></span></span></span><br><br><br> <p>The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.</p>\n\n<p>Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.</p>",
    "description_text": "This role partners cross-functionally with R&D, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, and Program Management to drive quality-focused decision making, risk-based development practices, and efficient execution of development programs. The Senior Manager establishes and maintains Design Assurance methodologies, systems, and best practices aligned with applicable global regulatory requirements and industry standards.\n Key responsibilities include: Establish and maintain Design Assurance processes, tools, and governance supporting compliant and efficient product development.\n Provide strategic and tactical quality leadership across new product development, sustaining engineering, and design change activities.\n Ensure effective implementation of Design Controls, Risk Management, Verification & Validation, usability engineering, and design transfer requirements.\n Drive quality awareness, visibility, and communication across development teams to support functional and business objectives.\n Develop organizational capability through coaching, mentoring, and talent development of Design Assurance personnel.\n ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Lead Design Assurance activities supporting new product development, sustaining engineering, and lifecycle management activities.\n Provide oversight and guidance on implementation of Design Controls in accordance with internal procedures and applicable regulatory requirements.\n Lead and develop Design Assurance personnel including resource planning, hiring, performance management, mentoring, and career development.\n Partner with R&D and cross-functional teams to define development strategies that incorporate quality, reliability, manufacturability, and regulatory expectations.\n Provide leadership on development and execution of design verification and validation strategies, including protocol review, traceability, and objective evidence of compliance.\n Ensure robust application of risk management principles throughout the product lifecycle, including hazard analysis, risk evaluation, risk controls, and benefit-risk assessments.\n Guide teams in development of product requirements, design inputs/outputs, acceptance criteria, and design transfer readiness.\n Review and approve key design deliverables including design plans, requirements, risk documentation, V&V documentation, DHF content, and design changes.\n Drive product quality improvements through analysis of product performance, complaint trends, reliability data, and development metrics.\n Facilitate root cause investigations and corrective/preventive action activities associated with design-related issues.\n Collaborate with Manufacturing and Operations teams to ensure effective transfer of product designs into production and commercialization.\n Champion continuous improvement initiatives to streamline product development processes while maintaining compliance.\n Establish and monitor Design Assurance metrics to evaluate development effectiveness, product quality, and organizational performance.\n Support internal and external audits, regulatory inspections, and responses associated with product development activities.\n EDUCATION/EXPERIENCE:\n Bachelor’s degree in Engineering or related technical discipline required; advanced degree preferred.\n Minimum of 8–10 years of progressive experience in medical device Quality and/or Design Assurance roles with demonstrated leadership experience.\n Minimum of 3–5 years of people leadership experience, including management of technical teams.\n Demonstrated experience supporting product development and commercialization under Design Controls in regulated environments.\n Strong working knowledge of applicable regulations and standards including 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR 2017/745, and IEC 60601 (where applicable).\n Experience with Design History File (DHF), risk management, verification and validation, usability engineering, and design transfer activities.\n Strong understanding of statistical methods, reliability engineering principles, and root cause investigation techniques.\n Demonstrated capability in cross-functional leadership, project execution, and decision making in fast-paced development environments.\n Working knowledge of Lean, Six Sigma, and continuous improvement methodologies preferred.\n ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification preferred.\n Lead Auditor certification preferred.\n   SUPERVISORY RESPONSIBILITIES\n  Responsible for leadership and development of Design Assurance personnel, including engineers and people leaders where applicable.\n Accountable for organizational capability, resource planning, performance management, and achievement of quality and development objectives.\n Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.\n Salary Range: $185,000 - $204,000\n Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.\n Join Us! Apply Today\n  The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.\n Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.",
    "jsonld_jobposting": {
      "url": "https://imperativecare.applytojob.com/apply/1uy3pyafxa/Sr-Manager-Design-Assurance",
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      "title": "Sr Manager, Design Assurance",
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      "datePosted": "2026-06-23",
      "description": "<span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>This role partners cross-functionally with R&D, Regulatory Affairs, Clinical, Manufacturing, Supply Chain, and Program Management to drive quality-focused decision making, risk-based development practices, and efficient execution of development programs. The Senior Manager establishes and maintains Design Assurance methodologies, systems, and best practices aligned with applicable global regulatory requirements and industry standards.</span></span></span></span></span></span><br><br><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Key responsibilities include:</span></span></span></span></span></span><ul><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Establish and maintain Design Assurance processes, tools, and governance supporting compliant and efficient product development.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Provide strategic and tactical quality leadership across new product development, sustaining engineering, and design change activities.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Ensure effective implementation of Design Controls, Risk Management, Verification & Validation, usability engineering, and design transfer requirements.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Drive quality awareness, visibility, and communication across development teams to support functional and business objectives.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Develop organizational capability through coaching, mentoring, and talent development of Design Assurance personnel.</span></span></span></span></span></span></li></ul><br><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:</span></span></span></span></span></span><ul><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Lead Design Assurance activities supporting new product development, sustaining engineering, and lifecycle management activities.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Provide oversight and guidance on implementation of Design Controls in accordance with internal procedures and applicable regulatory requirements.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Lead and develop Design Assurance personnel including resource planning, hiring, performance management, mentoring, and career development.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Partner with R&D and cross-functional teams to define development strategies that incorporate quality, reliability, manufacturability, and regulatory expectations.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Provide leadership on development and execution of design verification and validation strategies, including protocol review, traceability, and objective evidence of compliance.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Ensure robust application of risk management principles throughout the product lifecycle, including hazard analysis, risk evaluation, risk controls, and benefit-risk assessments.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Guide teams in development of product requirements, design inputs/outputs, acceptance criteria, and design transfer readiness.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Review and approve key design deliverables including design plans, requirements, risk documentation, V&V documentation, DHF content, and design changes.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Drive product quality improvements through analysis of product performance, complaint trends, reliability data, and development metrics.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Facilitate root cause investigations and corrective/preventive action activities associated with design-related issues.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Collaborate with Manufacturing and Operations teams to ensure effective transfer of product designs into production and commercialization.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Champion continuous improvement initiatives to streamline product development processes while maintaining compliance.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Establish and monitor Design Assurance metrics to evaluate development effectiveness, product quality, and organizational performance.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Support internal and external audits, regulatory inspections, and responses associated with product development activities.</span></span></span></span></span></span></li></ul><div style=\"border-bottom:solid 1pt;padding:0in 0in 1pt 0in;\"><span style=\"font-size:10pt;\"><span style=\"font-family:'Times New Roman', serif;\"><b><span lang=\"en-au\" style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\">EDUCATION/EXPERIENCE:                                                           </span></span></b></span></span></div><ul><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Bachelor’s degree in Engineering or related technical discipline required; advanced degree preferred.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Minimum of 8–10 years of progressive experience in medical device Quality and/or Design Assurance roles with demonstrated leadership experience.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Minimum of 3–5 years of people leadership experience, including management of technical teams.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Demonstrated experience supporting product development and commercialization under Design Controls in regulated environments.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Strong working knowledge of applicable regulations and standards including 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR 2017/745, and IEC 60601 (where applicable).</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Experience with Design History File (DHF), risk management, verification and validation, usability engineering, and design transfer activities.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Strong understanding of statistical methods, reliability engineering principles, and root cause investigation techniques.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Demonstrated capability in cross-functional leadership, project execution, and decision making in fast-paced development environments.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Working knowledge of Lean, Six Sigma, and continuous improvement methodologies preferred.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification preferred.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Lead Auditor certification preferred.</span></span></span></span></span></span></li></ul> <div style=\"border-bottom:solid 1pt;padding:0in 0in 1pt 0in;\"><span style=\"font-size:10pt;\"><span style=\"font-family:'Times New Roman', serif;\"><b><span lang=\"en-au\" style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\">SUPERVISORY RESPONSIBILITIES                                                               </span></span></b></span></span></div> <ul><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Responsible for leadership and development of Design Assurance personnel, including engineers and people leaders where applicable.</span></span></span></span></span></span></li><li><span style=\"font-size:10pt;\"><span><span style=\"font-family:'Times New Roman', serif;\"><span style=\"font-size:11pt;\"><span style=\"font-family:Calibri, sans-serif;\"><span>Accountable for organizational capability, resource planning, performance management, and achievement of quality and development objectives.</span></span></span></span></span></span></li></ul><span style=\"font-size:11pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Calibri, sans-serif;\"><b><span style=\"font-family:Roboto;\"><span style=\"color:#ed8b00;\">Employee Benefits</span></span></b> <span style=\"font-size:10pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Roboto;\">include </span></span></span><span style=\"font-size:10pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Roboto;\">a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.</span></span></span></span></span></span><br><strong><span style=\"font-size:11pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Calibri, sans-serif;\"><span style=\"font-family:Roboto;\">Salary Range: $185,000 - $204,000</span></span></span></span></strong><br><span style=\"font-size:11pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Calibri, sans-serif;\"><span style=\"font-size:10pt;\"><span style=\"background:#FFFFFF;\"><span style=\"line-height:115%;\"><span style=\"font-family:Roboto;\"><span style=\"color:#202124;\">Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. </span></span></span></span></span></span></span></span><br><span style=\"font-size:11pt;\"><span style=\"line-height:115%;\"><span style=\"font-family:Calibri, sans-serif;\"><b><span style=\"font-family:Roboto;\">Join Us! </span></b><a href=\"https://imperativecare.com/careers/\" style=\"color:#0000FF;text-decoration:underline;\"><b><span style=\"font-family:Roboto;\"><span style=\"color:#ed8b00;\">Apply Today</span></span></b></a></span></span></span><br><br><br> <p>The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.</p>\n\n<p>Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.</p>",
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