Senior Design Quality Engineer

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    "ShortDescriptionStr": "About CooperSurgical\n\nCooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. \n\nWork location: Trumbull, CT or Livingston, NJ (on-site)",
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    "ExternalDescriptionStr": "<p class=\"elementtoproof\"><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\"><strong>About CooperSurgical</strong></span></span></p><p style=\"background-color: white; margin-bottom: 0in;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at&nbsp;</span></span><a href=\"http://www.coopersurgical.com\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">www.coopersurgical.com</span></span></a><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"border: 1pt windowtext; padding: 0in;\">.&nbsp;</span></span></p><p style=\"margin: 0in;\">&nbsp;</p><p><span style=\"font-family: Arial, sans-serif;\"><strong>Work location:</strong> Trumbull, CT or Livingston, NJ (on-site)</span></p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Scope:&nbsp;</strong></span></p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\">The Senior Design Quality Engineer will be a key leader in ensuring the safety, effectiveness, and compliance of our medical devices throughout the design and development lifecycle. This position will play a critical role in implementing and maintaining robust quality management systems, leading design control activities, and collaborating with internal and external cross-functional teams to deliver cutting-edge medical solutions.</span></p><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Job Summary:</strong></span></p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\">The Senior Design Quality Engineer will provide Design Quality Engineering support and leadership to ensure the successful development of Cooper products and ongoing operational support, applying knowledge of design control principles and quality engineering techniques to positively influence development efforts as needed and ensure products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.<span>&nbsp; </span>The Senior Design Quality Engineer also reviews and evaluates scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. This position may also guide, coach, review and delegate work to lower-level specialists.</span></p>",
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    "ExternalPostedStartDate": "2026-06-04T16:11:36+00:00",
    "ExternalQualificationsStr": "<p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Knowledge, Skills and Abilities:</strong></span></p><p style=\"margin: 0in;\">&nbsp;</p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Knowledge of applicable laws and regulations.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Intermediate skills in Excel, Word and PowerPoint.&nbsp;Advanced skills preferred.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ability to read and understand highly technical material.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Proficient in reading and writing in English.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Self-motivated and committed to a team approach.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Strong interpersonal, organizational and project management skills.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Strong oral, presentation and technical writing skills.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Strong decision-making skills, preferably across a broad spectrum of Quality Engineering responsibilities.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Experience leading cross-functional teams in a medical device development environment.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Strong analytical and problem-solving skills with attention to detail. Knowledge of statistics and how to apply, evaluate, and provide recommendations from data.</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Work Environment:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Occasionally lift to 35 pounds.</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Experience:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">5+ years experience in Quality Engineering in the medical device industry. Experience in related engineering areas, e.g. R&amp;D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Experience in medical devices, with knowledge in women’s health is preferred.</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Education:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Bachelor’s Degree or higher in Science or Engineering (or related field).</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Certification in Quality Engineering (ASQ Certified Quality Engineer).</span></span></li></ul><p style=\"background-color: white;\">&nbsp;</p><p style=\"background-color: white;\">#LI-KA1</p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><strong>Our Benefits:</strong></span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at&nbsp;</span><a href=\"https://www.coopersurgical.com/\" target=\"_blank\" title=\"https://www.coopersurgical.com/\"><span style=\"color: rgb(0, 135, 204); font-family: Arial, sans-serif;\">www.coopersurgical.com</span></a><span style=\"color: black; font-family: Arial, sans-serif;\">&nbsp;to learn more about CooperSurgical and the benefits of becoming a member of our team.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">For U.S. locations that require disclosure of compensation, the starting base pay&nbsp;for this role is between&nbsp;$100,000.00 - $125,000.00 annually. The&nbsp;actual base pay&nbsp;includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.</span></span></p>",
    "InternalQualificationsStr": "<p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Knowledge, Skills and Abilities:</strong></span></p><p style=\"margin: 0in;\">&nbsp;</p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Knowledge of applicable laws and regulations.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Intermediate skills in Excel, Word and PowerPoint.&nbsp;Advanced skills preferred.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Ability to read and understand highly technical material.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Proficient in reading and writing in English.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Self-motivated and committed to a team approach.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Strong interpersonal, organizational and project management skills.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Strong oral, presentation and technical writing skills.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Strong decision-making skills, preferably across a broad spectrum of Quality Engineering responsibilities.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Experience leading cross-functional teams in a medical device development environment.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Strong analytical and problem-solving skills with attention to detail. Knowledge of statistics and how to apply, evaluate, and provide recommendations from data.</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Work Environment:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Occasionally lift to 35 pounds.</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Experience:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">5+ years experience in Quality Engineering in the medical device industry. Experience in related engineering areas, e.g. R&amp;D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Experience in medical devices, with knowledge in women’s health is preferred.</span></span></li></ul><p style=\"margin: 0in;\">&nbsp;</p><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Education:</strong></span></p><ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Bachelor’s Degree or higher in Science or Engineering (or related field).</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Certification in Quality Engineering (ASQ Certified Quality Engineer).</span></span></li></ul><p style=\"background-color: white;\">&nbsp;</p><p style=\"background-color: white;\">#LI-KA1</p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><strong>Our Benefits:</strong></span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at&nbsp;</span><a href=\"https://www.coopersurgical.com/\" target=\"_blank\" title=\"https://www.coopersurgical.com/\"><span style=\"color: rgb(0, 135, 204); font-family: Arial, sans-serif;\">www.coopersurgical.com</span></a><span style=\"color: black; font-family: Arial, sans-serif;\">&nbsp;to learn more about CooperSurgical and the benefits of becoming a member of our team.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\">We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.</span></p><p style=\"background-color: white;\"><span style=\"color: black; font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">For U.S. locations that require disclosure of compensation, the starting base pay&nbsp;for this role is between&nbsp;$100,000.00 - $125,000.00 annually. The&nbsp;actual base pay&nbsp;includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.</span></span></p>",
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    "ExternalResponsibilitiesStr": "<ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Quality Representation</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Actively represent Quality function on product/process development teams.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Mentor other disciplines as needed in the Quality Engineering methodology.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Provide guidance to Engineering staff and other personnel ensuring design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Supplier Engagement</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Manage supplier new tooling to ensure final components are qualified at the supplier and on time utilizing PPAP tool.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Participate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper’s specifications.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with Engineering Team.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">CAPAs/Non conformances</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Lead or participate in the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Evaluate and disposition nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Design&nbsp;</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Participate in design reviews to evaluate designs and help identify alternative design solutions.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Hands-on participant in early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Contribute to design input requirements from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">V&amp;V</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Participate in the development of the master test plans (I.E. trace matrix, VMP….) that encompass design verification, design validation and process validation activities.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Creation, evaluation, and validation of product and process test methods.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Evaluate test protocols and reports to ensure testing is sufficient to meet regulatory requirements and quality objectives.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Risk</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Identify and manage risk throughout the development process with the use of FMEAs and/or other risk management tools. This includes leading Risk management efforts of the design process and working with design and management team on managing product and process risks.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Process Improvement</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Actively identify and lead opportunities for improvements across all cross functional departments.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Promote continuous improvement in design control activities and use of quality tools with design team and other departments.&nbsp;</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Regulatory</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Comply with applicable FDA and international regulatory laws/standards and Cooper’s Code of Conduct.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Maintain knowledge of current regulatory requirements and standards as they pertain to development and release of medical devices.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Represent Cooper as needed in FDA, notified body, internal, and other audits.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Perform other duties as assigned.</span></span></li></ul><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Travel:</strong> This position may require 0-5% domestic and/or international travel.&nbsp;</span></p>",
    "InternalResponsibilitiesStr": "<ul style=\"list-style-type: disc;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Quality Representation</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Actively represent Quality function on product/process development teams.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Mentor other disciplines as needed in the Quality Engineering methodology.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Provide guidance to Engineering staff and other personnel ensuring design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Supplier Engagement</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Manage supplier new tooling to ensure final components are qualified at the supplier and on time utilizing PPAP tool.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Participate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper’s specifications.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with Engineering Team.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">CAPAs/Non conformances</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Lead or participate in the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Evaluate and disposition nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Design&nbsp;</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Participate in design reviews to evaluate designs and help identify alternative design solutions.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Hands-on participant in early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Contribute to design input requirements from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">V&amp;V</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Participate in the development of the master test plans (I.E. trace matrix, VMP….) that encompass design verification, design validation and process validation activities.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Creation, evaluation, and validation of product and process test methods.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Evaluate test protocols and reports to ensure testing is sufficient to meet regulatory requirements and quality objectives.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Risk</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Identify and manage risk throughout the development process with the use of FMEAs and/or other risk management tools. This includes leading Risk management efforts of the design process and working with design and management team on managing product and process risks.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Process Improvement</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Actively identify and lead opportunities for improvements across all cross functional departments.&nbsp;</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Promote continuous improvement in design control activities and use of quality tools with design team and other departments.&nbsp;</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Regulatory</span></span><ul style=\"list-style-type: circle;\"><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Comply with applicable FDA and international regulatory laws/standards and Cooper’s Code of Conduct.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Maintain knowledge of current regulatory requirements and standards as they pertain to development and release of medical devices.</span></span></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Represent Cooper as needed in FDA, notified body, internal, and other audits.</span></span></li></ul></li><li><span style=\"font-family: Arial, sans-serif;\"><span style=\"font-size: 10pt;\">Perform other duties as assigned.</span></span></li></ul><p style=\"margin: 0in;\"><span style=\"font-family: Arial, sans-serif;\"><strong>Travel:</strong> This position may require 0-5% domestic and/or international travel.&nbsp;</span></p>",
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