{"schemaVersion":"jobsearcher.job.v1","id":"5b11776d8e3cb210ebbf877d","url":"https://jobsearcher.com/jobs/5b11776d8e3cb210ebbf877d","canonicalUrl":"https://jobsearcher.com/jobs/5b11776d8e3cb210ebbf877d","title":"Mechanical Engineer","description":"Roles & Responsibilities\n\nAct as technical lead for mechanical design within electromechanical medical device programs.\n\nOwn the mechanical architecture and interfaces for electro‑mechanical subsystems including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.\n\nLead end‑to‑end mechanical design activities from concept, feasibility, and prototyping to design freeze and production release.\n\nTranslate user needs, system requirements, and electrical/software constraints into robust mechanical designs.\n\nDevelop and review 3D CAD models, detailed drawings, GD&T, and BOMs.\n\nEnsure proper integration of motors, sensors, PCBs, batteries, power supplies, connectors, and cabling within mechanical assemblies.\n\nExecute development activities in compliance with ISO 13485, FDA 21 CFR 820, ISO 14971, and applicable IEC standards.\n\nEnsure completeness and quality of Design History File (DHF) documentation.\n\nLead and participate in risk management activities (dFMEA, pFMEA, hazard analysis) with cross‑functional teams.\n\nSupport design changes through formal ECO/ECN processes.\n\nDefine mechanical verification strategies and support DVT, EVT, and V&V testing.\n\nInvestigate and resolve failures observed during testing, manufacturing, or field feedback.\n\nLead application of DFM/DFA principles for manufacturing processes.\n\nWork closely with suppliers and contract manufacturers on tooling, materials, processes, and yield improvement.\n\nSupport FAI, PPAP, pilot builds, and design transfer to manufacturing.\n\nDrive resolution of manufacturing issues, NCRs, and deviations related to mechanical design.\n\nCollaborate with electronics, software, systems, quality, regulatory, and supply chain teams.\n\nLead and participate in design reviews, technical discussions, and customer walkthroughs.\n\nGuide and perform engineering analyses including tolerance stack‑ups (hand calculations and FEA).\n\nProvide technical input for cost reduction, design optimization, and next‑generation improvements.\n\nMentor and technically guide junior and mid‑level engineers.\n\nRequirements\n\n8+ years of experience in mechanical design and development, with significant experience in medical device NPD.\n\nProven experience leading mechanical development of electromechanical products through full product lifecycle in regulated environments.\n\nBachelor's or Master's degree in Mechanical Engineering.\n\nRequired Technical Skills\n\nStrong proficiency in CAD tools such as SolidWorks or Creo.\n\nIn‑depth knowledge of materials and manufacturing processes for medical devices.\n\nStrong understanding of electromechanical integration, thermal considerations, EMI/EMC‑aware mechanical design, and reliability.\n\nExpertise in GD&T (ASME Y14.5), tolerance stack‑up, and DFM/DFA.\n\nKnowledge of FEA and practical engineering calculations.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Dublin","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-07-08T03:26:14.817Z","occupations":[{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"}],"industries":[{"code":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-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":"Mechanical Engineer","description":"Roles & Responsibilities\n\nAct as technical lead for mechanical design within electromechanical medical device programs.\n\nOwn the mechanical architecture and interfaces for electro‑mechanical subsystems including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.\n\nLead end‑to‑end mechanical design activities from concept, feasibility, and prototyping to design freeze and production release.\n\nTranslate user needs, system requirements, and electrical/software constraints into robust mechanical designs.\n\nDevelop and review 3D CAD models, detailed drawings, GD&T, and BOMs.\n\nEnsure proper integration of motors, sensors, PCBs, batteries, power supplies, connectors, and cabling within mechanical assemblies.\n\nExecute development activities in compliance with ISO 13485, FDA 21 CFR 820, ISO 14971, and applicable IEC standards.\n\nEnsure completeness and quality of Design History File (DHF) documentation.\n\nLead and participate in risk management activities (dFMEA, pFMEA, hazard analysis) with cross‑functional teams.\n\nSupport design changes through formal ECO/ECN processes.\n\nDefine mechanical verification strategies and support DVT, EVT, and V&V testing.\n\nInvestigate and resolve failures observed during testing, manufacturing, or field feedback.\n\nLead application of DFM/DFA principles for manufacturing processes.\n\nWork closely with suppliers and contract manufacturers on tooling, materials, processes, and yield improvement.\n\nSupport FAI, PPAP, pilot builds, and design transfer to manufacturing.\n\nDrive resolution of manufacturing issues, NCRs, and deviations related to mechanical design.\n\nCollaborate with electronics, software, systems, quality, regulatory, and supply chain teams.\n\nLead and participate in design reviews, technical discussions, and customer walkthroughs.\n\nGuide and perform engineering analyses including tolerance stack‑ups (hand calculations and FEA).\n\nProvide technical input for cost reduction, design optimization, and next‑generation improvements.\n\nMentor and technically guide junior and mid‑level engineers.\n\nRequirements\n\n8+ years of experience in mechanical design and development, with significant experience in medical device NPD.\n\nProven experience leading mechanical development of electromechanical products through full product lifecycle in regulated environments.\n\nBachelor's or Master's degree in Mechanical Engineering.\n\nRequired Technical Skills\n\nStrong proficiency in CAD tools such as SolidWorks or Creo.\n\nIn‑depth knowledge of materials and manufacturing processes for medical devices.\n\nStrong understanding of electromechanical integration, thermal considerations, EMI/EMC‑aware mechanical design, and reliability.\n\nExpertise in GD&T (ASME Y14.5), tolerance stack‑up, and DFM/DFA.\n\nKnowledge of FEA and practical engineering calculations.\n\n#J-18808-Ljbffr","datePosted":"2026-07-08T03:26:14.817Z","dateModified":"2026-07-08T03:26:14.817Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dublin","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"5b11776d8e3cb210ebbf877d"},"url":"https://jobsearcher.com/jobs/5b11776d8e3cb210ebbf877d"}}