{"schemaVersion":"jobsearcher.job.v1","id":"873bf852a6f3ab8591b5bef3","url":"https://jobsearcher.com/jobs/873bf852a6f3ab8591b5bef3","canonicalUrl":"https://jobsearcher.com/jobs/873bf852a6f3ab8591b5bef3","title":"Product Development and Engineering Manager","description":"DermaSensor is seeking a dynamic, detail-oriented leader to manage cross-functional product development and quality engineering initiatives. This hybrid role serves as the project manager for software development and sustaining engineering activities, while also owning critical quality engineering functions related to design control. The ideal candidate will drive hardware and software development initiatives with internal and external teams, while ensuring requirements management, risk management, and validation efforts align with global regulatory expectations. You will work closely with our Quality & Compliance Manager to ensure overall QMS compliance.\nAbout DermaSensor, Inc\nDermaSensor Inc. is a fast-growing, Miami-based medical device company focused on empowering healthcare professionals with clinically proven solutions to efficiently detect skin cancer using the latest advancements in medical-grade technology. Our flagship product, the FDA-cleared DermaSensor™ medical device, is a cost-effective handheld solution that combines artificial intelligence and spectroscopy to assess suspicious skin lesions for skin cancer risk in just seconds. By enabling real-time, accurate assessments, DermaSensor aims to dramatically improve early detection rates, increase access to vital healthcare, and ultimately save lives. Join us as we reshape the future of healthcare with groundbreaking technology designed to make a lasting impact on patient care and outcomes.\nDescription\nThe Product Development and Quality Engineering Manager will:\nProject Management\nLead Agile software development and documentation initiatives with internal and external engineering teams, aligned with IEC 62304 and SaMD requirements.\nManage sustaining engineering projects and production planning with contract manufacturers, focusing on product and production improvements, cost reductions, and supply continuity.\nMaintain integrated schedules, risks, and cross-functional alignment across engineering and production teams and commercial demands.\nFacilitate sprint planning, technical reviews, and cross-functional coordination to drive on-time execution.\nTrack and report on project status, risks, and key milestones to senior leadership.\nQuality Engineering\nCollaborate with the Quality & Compliance Manager to maintain and improve the QMS in accordance with FDA 21 CFR Part 820, ISO 13485, and EU MDR.\nLead requirements management to ensure all system, software, and hardware specifications are complete, testable, and aligned across disciplines.\nDrive risk management activities in accordance with ISO 14971, including updates to risk files and mitigation tracking.\nDevelop and maintain V&V protocols and reports for software updates, manufacturing changes, and product improvements, including compliance with IEC 60601 and IEC 62304.\nOwn traceability between design inputs, risk controls, and verification/validation (V&V) activities.\nMaintain design documentation such as DHF, DMR, and engineering change orders (ECOs), ensuring quality system alignment.\nLead design reviews, design change control boards, and risk reviews to ensure disciplined design control processes.\nSupport software and hardware root cause investigations for field issues, manufacturing deviations, or test failures.\nLead product/production investigations and collaborate with development, product and quality system teams to identify failure modes, analyze issues, and drive corrective/preventive actions (CAPA).\nParticipate in post-market surveillance activities by investigating and resolving issues raised through complaints or quality events.\nContribute to ongoing design history file and technical document maintenance, as needed for regulatory submissions and audits.\nQualifications/Requirements:\nBachelor’s or Master’s degree in Engineering (Biomedical, Electrical, Mechanical, or related field).\n7+ years of experience in medical device development, design engineering, quality engineering, or technical project management.\nStrong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR.\nExperience with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety & EMC).\nProven ability to manage cross-functional software and hardware projects, ideally in a sustaining or post-market context.\nHands-on experience with design control, requirements management, risk analysis, and V&V documentation.\nFamiliarity with CAPA processes and leading root cause investigations with software and hardware teams.\nExperience working with or managing external design firms and contract manufacturers\n\nDesired Characteristics:\nExperience with spectroscopy, electromechanical systems, embedded devices, or diagnostic tools.\nExposure to SaMD development or integration into connected systems.\nAgile/SCRUM project management experience; PMP certification is a plus.\nExperience using tools such as JIRA, Confluence, or equivalent for design control and project tracking.\nPrevious experience contributing to 510(k), De Novo, or CE Mark submissions.\nStrong analytical and problem-solving skills; structured approach to root cause investigation and design validation.\nHigh attention to detail with excellent documentation and organizational discipline.\nProactive and accountable; thrives in a fast-paced, high-ownership environment.\nCollaborative, team-first mindset with the ability to lead cross-functional discussions and drive alignment.\nExcellent written and verbal communication skills, particularly in translating technical information for varied audiences.","company":"Dermasensor","rawCompany":"dermasensor","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-06T12:51:34.351Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Product Development and Engineering Manager","description":"DermaSensor is seeking a dynamic, detail-oriented leader to manage cross-functional product development and quality engineering initiatives. This hybrid role serves as the project manager for software development and sustaining engineering activities, while also owning critical quality engineering functions related to design control. The ideal candidate will drive hardware and software development initiatives with internal and external teams, while ensuring requirements management, risk management, and validation efforts align with global regulatory expectations. You will work closely with our Quality & Compliance Manager to ensure overall QMS compliance.\nAbout DermaSensor, Inc\nDermaSensor Inc. is a fast-growing, Miami-based medical device company focused on empowering healthcare professionals with clinically proven solutions to efficiently detect skin cancer using the latest advancements in medical-grade technology. Our flagship product, the FDA-cleared DermaSensor™ medical device, is a cost-effective handheld solution that combines artificial intelligence and spectroscopy to assess suspicious skin lesions for skin cancer risk in just seconds. By enabling real-time, accurate assessments, DermaSensor aims to dramatically improve early detection rates, increase access to vital healthcare, and ultimately save lives. Join us as we reshape the future of healthcare with groundbreaking technology designed to make a lasting impact on patient care and outcomes.\nDescription\nThe Product Development and Quality Engineering Manager will:\nProject Management\nLead Agile software development and documentation initiatives with internal and external engineering teams, aligned with IEC 62304 and SaMD requirements.\nManage sustaining engineering projects and production planning with contract manufacturers, focusing on product and production improvements, cost reductions, and supply continuity.\nMaintain integrated schedules, risks, and cross-functional alignment across engineering and production teams and commercial demands.\nFacilitate sprint planning, technical reviews, and cross-functional coordination to drive on-time execution.\nTrack and report on project status, risks, and key milestones to senior leadership.\nQuality Engineering\nCollaborate with the Quality & Compliance Manager to maintain and improve the QMS in accordance with FDA 21 CFR Part 820, ISO 13485, and EU MDR.\nLead requirements management to ensure all system, software, and hardware specifications are complete, testable, and aligned across disciplines.\nDrive risk management activities in accordance with ISO 14971, including updates to risk files and mitigation tracking.\nDevelop and maintain V&V protocols and reports for software updates, manufacturing changes, and product improvements, including compliance with IEC 60601 and IEC 62304.\nOwn traceability between design inputs, risk controls, and verification/validation (V&V) activities.\nMaintain design documentation such as DHF, DMR, and engineering change orders (ECOs), ensuring quality system alignment.\nLead design reviews, design change control boards, and risk reviews to ensure disciplined design control processes.\nSupport software and hardware root cause investigations for field issues, manufacturing deviations, or test failures.\nLead product/production investigations and collaborate with development, product and quality system teams to identify failure modes, analyze issues, and drive corrective/preventive actions (CAPA).\nParticipate in post-market surveillance activities by investigating and resolving issues raised through complaints or quality events.\nContribute to ongoing design history file and technical document maintenance, as needed for regulatory submissions and audits.\nQualifications/Requirements:\nBachelor’s or Master’s degree in Engineering (Biomedical, Electrical, Mechanical, or related field).\n7+ years of experience in medical device development, design engineering, quality engineering, or technical project management.\nStrong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR.\nExperience with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety & EMC).\nProven ability to manage cross-functional software and hardware projects, ideally in a sustaining or post-market context.\nHands-on experience with design control, requirements management, risk analysis, and V&V documentation.\nFamiliarity with CAPA processes and leading root cause investigations with software and hardware teams.\nExperience working with or managing external design firms and contract manufacturers\n\nDesired Characteristics:\nExperience with spectroscopy, electromechanical systems, embedded devices, or diagnostic tools.\nExposure to SaMD development or integration into connected systems.\nAgile/SCRUM project management experience; PMP certification is a plus.\nExperience using tools such as JIRA, Confluence, or equivalent for design control and project tracking.\nPrevious experience contributing to 510(k), De Novo, or CE Mark submissions.\nStrong analytical and problem-solving skills; structured approach to root cause investigation and design validation.\nHigh attention to detail with excellent documentation and organizational discipline.\nProactive and accountable; thrives in a fast-paced, high-ownership environment.\nCollaborative, team-first mindset with the ability to lead cross-functional discussions and drive alignment.\nExcellent written and verbal communication skills, particularly in translating technical information for varied audiences.","datePosted":"2026-08-06T12:51:34.351Z","dateModified":"2026-08-06T12:51:34.351Z","hiringOrganization":{"@type":"Organization","name":"Dermasensor","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"873bf852a6f3ab8591b5bef3"},"url":"https://jobsearcher.com/jobs/873bf852a6f3ab8591b5bef3"}}