{"schemaVersion":"jobsearcher.job.v1","id":"5e08df9562db3d7eef34fec5","url":"https://jobsearcher.com/jobs/5e08df9562db3d7eef34fec5","canonicalUrl":"https://jobsearcher.com/jobs/5e08df9562db3d7eef34fec5","title":"Mechanical Engineer","description":"We are seeking an experienced Mechanical R&D Engineer with deep expertise in the EU Medical Device Regulation (EU MDR 2017/745) to join our team. This role will support the design, development, documentation, and compliance strategy for medical devices intended for the EU market. The ideal candidate has a strong engineering foundation combined with hands‑on experience navigating EU MDR requirements throughout the product lifecycle.\nAs part of the R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing to ensure that products meet both technical performance expectations and global regulatory obligations.\nDesign & Development\nLead and support remediation design activities for medical devices in accordance with EU MDR and ISO 13485.\nConduct engineering studies, testing, and technical evaluations, ensuring design controls are fully aligned with regulatory requirements.\nGenerate technical documentation including design inputs/outputs, risk analyses, verification and validation protocols, and test reports.\nEU MDR Compliance\nDevelop, update, and maintain Technical Documentation (TD) and Technical Files to satisfy EU MDR Annex II and III requirements.\nEnsure compliance with General Safety and Performance Requirements (GSPR).\nSupport clinical evaluation, post‑market surveillance, and post‑market clinical follow-up documentation as needed.\nRisk Management\nPerform and maintain risk management activities in alignment with ISO 14971.\nLead or support FMEA, fault-tree analysis, and other risk assessment tools.\nCross-functional Collaboration\nWork with Quality to ensure design documentation, DHFs, and updates meet internal SOPs and external regulatory standards.\nSupport manufacturing transfer activities and design changes.\nContribute to project planning, schedule development, and technical decision making.\nTesting & Verification\nDesign and execute verification and validation (V&V) testing to demonstrate safety, performance, and regulatory compliance.\nLead investigations of design issues, CAPAs, and nonconformances impacting EU markets.\nRequired\nBachelor’s or Master’s degree in Mechanical, Biomedical, Electrical, or related Engineering field.\n3–7+ years of experience in R&D within the medical device industry.\nDemonstrated experience preparing EU MDR–compliant technical documentation.\nStrong understanding of design controls (21 CFR 820.30), ISO 13485, ISO 14971, and IEC/ISO standards related to the product type.\nProven experience interacting with Notified Bodies or supporting NB audits.\nExcellent technical writing skills and ability to produce audit‑ready documentation.\nPreferred\nExperience with Class IIb or Class III medical devices.\nPrior experience with EU MDD-to-MDR transition projects.\nExperience with coordinating with Regulatory Affairs to address Notified Body questions, audits, and remediation actions.\nSolidWorks and Windchill experience.\nExperience following IEC 60601 medical electrical equipment safety requirements.\nSoft Skills\nStrong problem‑solving and analytical abilities.\nAbility to communicate complex technical topics clearly to both technical and non‑technical audiences.\nCollaborative mindset with ability to work cross‑functionally in a regulated environment.\nHighly organized with strong attention to detail.\nPay: $54.00 - $57.00 per hour\nBenefits:\n401(k)\nDental insurance\nFlexible schedule\nFlexible spending account\nHealth insurance\nHealth savings account\nLife insurance\nPaid time off\nVision insurance\nWork Location: Remote","company":"Actalent Services","rawCompany":"actalent services","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-04T21:25:12.747Z","occupations":[{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Mechanical Engineer","description":"We are seeking an experienced Mechanical R&D Engineer with deep expertise in the EU Medical Device Regulation (EU MDR 2017/745) to join our team. This role will support the design, development, documentation, and compliance strategy for medical devices intended for the EU market. The ideal candidate has a strong engineering foundation combined with hands‑on experience navigating EU MDR requirements throughout the product lifecycle.\nAs part of the R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing to ensure that products meet both technical performance expectations and global regulatory obligations.\nDesign & Development\nLead and support remediation design activities for medical devices in accordance with EU MDR and ISO 13485.\nConduct engineering studies, testing, and technical evaluations, ensuring design controls are fully aligned with regulatory requirements.\nGenerate technical documentation including design inputs/outputs, risk analyses, verification and validation protocols, and test reports.\nEU MDR Compliance\nDevelop, update, and maintain Technical Documentation (TD) and Technical Files to satisfy EU MDR Annex II and III requirements.\nEnsure compliance with General Safety and Performance Requirements (GSPR).\nSupport clinical evaluation, post‑market surveillance, and post‑market clinical follow-up documentation as needed.\nRisk Management\nPerform and maintain risk management activities in alignment with ISO 14971.\nLead or support FMEA, fault-tree analysis, and other risk assessment tools.\nCross-functional Collaboration\nWork with Quality to ensure design documentation, DHFs, and updates meet internal SOPs and external regulatory standards.\nSupport manufacturing transfer activities and design changes.\nContribute to project planning, schedule development, and technical decision making.\nTesting & Verification\nDesign and execute verification and validation (V&V) testing to demonstrate safety, performance, and regulatory compliance.\nLead investigations of design issues, CAPAs, and nonconformances impacting EU markets.\nRequired\nBachelor’s or Master’s degree in Mechanical, Biomedical, Electrical, or related Engineering field.\n3–7+ years of experience in R&D within the medical device industry.\nDemonstrated experience preparing EU MDR–compliant technical documentation.\nStrong understanding of design controls (21 CFR 820.30), ISO 13485, ISO 14971, and IEC/ISO standards related to the product type.\nProven experience interacting with Notified Bodies or supporting NB audits.\nExcellent technical writing skills and ability to produce audit‑ready documentation.\nPreferred\nExperience with Class IIb or Class III medical devices.\nPrior experience with EU MDD-to-MDR transition projects.\nExperience with coordinating with Regulatory Affairs to address Notified Body questions, audits, and remediation actions.\nSolidWorks and Windchill experience.\nExperience following IEC 60601 medical electrical equipment safety requirements.\nSoft Skills\nStrong problem‑solving and analytical abilities.\nAbility to communicate complex technical topics clearly to both technical and non‑technical audiences.\nCollaborative mindset with ability to work cross‑functionally in a regulated environment.\nHighly organized with strong attention to detail.\nPay: $54.00 - $57.00 per hour\nBenefits:\n401(k)\nDental insurance\nFlexible schedule\nFlexible spending account\nHealth insurance\nHealth savings account\nLife insurance\nPaid time off\nVision insurance\nWork Location: Remote","datePosted":"2026-08-04T21:25:12.747Z","dateModified":"2026-08-04T21:25:12.747Z","hiringOrganization":{"@type":"Organization","name":"Actalent Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"5e08df9562db3d7eef34fec5"},"url":"https://jobsearcher.com/jobs/5e08df9562db3d7eef34fec5"}}