Human Factors Engineer - Medical Devices

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    "description_html": "<p>Location: Remote. US-based candidates only.  <br>Employment Type: Part-time contract (W2 hourly or C2C).<br>Duration: 3-month contract to start with. Possibility of renewal (part-time or full-time hours) depending on personal performance and business needs.<br>Compensation: $45/hr - $55/hr W2 hourly or $50 - $65/hr C2C. <br>Requirements: must be authorized to work legally in the US without sponsorship, now or in the future.<br><br><strong>About Us</strong><br>Concord isn't your typical consulting firm; we are an execution company with a passion for making things happen. Our mission is to help clients enhance customer experiences, optimize operations, and revolutionize their product offerings through seamless integration, optimization, and activation of technology and data.<br><br>We are purpose-built, merging the industry’s top specialty companies to amplify our Innovation Capabilities in analytics & AI, data management & engineering, UX and digital experience, and technical platform integration, automation & security engineering.<br><br><strong>About the Role</strong><br>We are seeking a Human Factors Engineer with knowledge of medical device usability. In this role, you will join our client's global customer experience and solution design team to redefine user interface and product design and help transform the healthcare industry. You will work with an international group of designers dedicated to bringing the voice of the customer to the core of product decisions — designing and enabling a seamless, patient-centric experience across a portfolio of medical devices and services.<br><br><strong>What You’ll Be Doing</strong></p><ul><li>Serve as the voice of patients and end users in all product-related discussions.</li><li>Analyze user profiles, tasks, hazard-related use scenarios, usability risks, requirements, and HF-related V&V.</li><li>Create medical device usability deliverables in accordance with IEC 62366, IEC 62304, and FDA guidance on Human Factors Engineering.</li><li>Plan and execute formative and summative usability studies; coordinate external suppliers as needed.</li><li>Prepare, maintain, and review Usability Engineering Files for multiple products.</li><li>Advocate for safety, efficacy, accessibility, quality, and usability for end users.</li><li>Provide guidance and mentorship on Human Factors Engineering practices to other design team members throughout the product design and development process.</li></ul><p><br><strong>What We’re Looking For</strong></p><ul><li>5+ years of experience in applied Human Factors Engineering and Design Control Management.</li><li>Master's degree in Science, Industrial Engineering, Human Factors Engineering, or a related technical field.</li><li>Experience with the Usability Engineering process for medical devices.</li><li>Proven ability to plan, execute, and document usability studies in a medical context.</li><li>Solid knowledge of ISO 14971, IEC 62304, and IEC 62366.</li><li>Experience in collecting and analyzing physiological and behavioral data.</li><li>Excellent communication and presentation skills.</li><li>Experience creating, facilitating, and analyzing workshops with end users and engineers is a strong plus.</li><li>Fluency in English required; additional languages are a plus.</li><li>Knowledge or background in UX or UI design is a plus.</li></ul><p><br><strong>What We Offer (W-2 Employment)</strong></p><ul><li>Health, Dental, and Vision Insurance - Comprehensive coverage to support your overall well-being.</li><li>Employer Contributions to Health Savings Accounts (HSA) - For employees enrolled in High Deductible Health Plans, Concord contributes toward your HSA.</li><li>Flexible Spending Accounts (FSA) - Options for healthcare and dependent care expenses, plus a Lifestyle Spending Account (LSA) for wellness and personal development.</li><li>Disability Insurance - Short-term (up to 12 weeks) and long-term coverage, fully paid by the employer.</li><li>Life and AD&D Insurance - Employer-provided coverage of with options for additional voluntary coverage.</li><li>Employee Assistance Program (EAP) - Support for legal, financial, and personal challenges. </li><li>401(k) Retirement Savings - 1% employer match. </li><li>Career Growth Opportunities - Pathways for advancement and skill development.</li><li>Team Engagement Activities - Regular team-building events and company-sponsored activities to foster collaboration and connection.</li></ul><p>***</p>\n\n<p>Concord is an execution partner helping organizations drive digital transformation, modernization, and scalable technology solutions. We deliver results that solve real business challenges. We operate globally and are growing fast, shaping the future of technology. Join a team trusted by top companies to drive strategic growth and operational excellence!</p>",
    "description_text": "Location: Remote. US-based candidates only.\nEmployment Type: Part-time contract (W2 hourly or C2C).\nDuration: 3-month contract to start with. Possibility of renewal (part-time or full-time hours) depending on personal performance and business needs.\nCompensation: $45/hr - $55/hr W2 hourly or $50 - $65/hr C2C.\nRequirements: must be authorized to work legally in the US without sponsorship, now or in the future.\n About Us\nConcord isn't your typical consulting firm; we are an execution company with a passion for making things happen. Our mission is to help clients enhance customer experiences, optimize operations, and revolutionize their product offerings through seamless integration, optimization, and activation of technology and data.\nWe are purpose-built, merging the industry’s top specialty companies to amplify our Innovation Capabilities in analytics & AI, data management & engineering, UX and digital experience, and technical platform integration, automation & security engineering.\n About the Role\nWe are seeking a Human Factors Engineer with knowledge of medical device usability. In this role, you will join our client's global customer experience and solution design team to redefine user interface and product design and help transform the healthcare industry. You will work with an international group of designers dedicated to bringing the voice of the customer to the core of product decisions — designing and enabling a seamless, patient-centric experience across a portfolio of medical devices and services.\n What You’ll Be Doing\n Serve as the voice of patients and end users in all product-related discussions.\n Analyze user profiles, tasks, hazard-related use scenarios, usability risks, requirements, and HF-related V&V.\n Create medical device usability deliverables in accordance with IEC 62366, IEC 62304, and FDA guidance on Human Factors Engineering.\n Plan and execute formative and summative usability studies; coordinate external suppliers as needed.\n Prepare, maintain, and review Usability Engineering Files for multiple products.\n Advocate for safety, efficacy, accessibility, quality, and usability for end users.\n Provide guidance and mentorship on Human Factors Engineering practices to other design team members throughout the product design and development process.\n What We’re Looking For\n 5+ years of experience in applied Human Factors Engineering and Design Control Management.\n Master's degree in Science, Industrial Engineering, Human Factors Engineering, or a related technical field.\n Experience with the Usability Engineering process for medical devices.\n Proven ability to plan, execute, and document usability studies in a medical context.\n Solid knowledge of ISO 14971, IEC 62304, and IEC 62366.\n Experience in collecting and analyzing physiological and behavioral data.\n Excellent communication and presentation skills.\n Experience creating, facilitating, and analyzing workshops with end users and engineers is a strong plus.\n Fluency in English required; additional languages are a plus.\n Knowledge or background in UX or UI design is a plus.\n What We Offer (W-2 Employment)\n Health, Dental, and Vision Insurance - Comprehensive coverage to support your overall well-being.\n Employer Contributions to Health Savings Accounts (HSA) - For employees enrolled in High Deductible Health Plans, Concord contributes toward your HSA.\n Flexible Spending Accounts (FSA) - Options for healthcare and dependent care expenses, plus a Lifestyle Spending Account (LSA) for wellness and personal development.\n Disability Insurance - Short-term (up to 12 weeks) and long-term coverage, fully paid by the employer.\n Life and AD&D Insurance - Employer-provided coverage of with options for additional voluntary coverage.\n Employee Assistance Program (EAP) - Support for legal, financial, and personal challenges.\n 401(k) Retirement Savings - 1% employer match.\n Career Growth Opportunities - Pathways for advancement and skill development.\n Team Engagement Activities - Regular team-building events and company-sponsored activities to foster collaboration and connection.\n ***\n Concord is an execution partner helping organizations drive digital transformation, modernization, and scalable technology solutions. We deliver results that solve real business challenges. We operate globally and are growing fast, shaping the future of technology. Join a team trusted by top companies to drive strategic growth and operational excellence!",
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