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Healthtech • Industrial • Manufacturing
Designs, prototypes, tests, and qualifies mechanical components for high-reliability medical devices. Investigates manufacturing and design failures, resolves production issues, evaluates non-conformances, develops manufacturing processes, reviews vendor validations, creates test plans, manages tooling, assesses risks, and maintains engineering documentation. Collaborates with electrical, software, design, and manufacturing teams to improve manufacturability, reliability, and cost effectiveness.
Top Skills:
MinitabSolidworksSolidworks Add-Ins
Healthtech • Industrial • Manufacturing
Supports sustaining medical device manufacturing and new product introduction on the swing shift. Troubleshoots hardware, system, process, and technical issues; improves yields, defects, scrap, and cycle time; maintains automated processes, tooling, fixtures, and test equipment; performs equipment and process validation; investigates failures and rejects; supports CAPA, preventive maintenance, documentation, and medical device quality system compliance.
Top Skills:
21 Cfr Part 820Automated Manufacturing ProcessesCanadian Medical Device Regulations (Cmdr)CapaDesign Of ExperimentsFda Quality System Regulation (Qsr)FmeaIq/Oq/PqIso 13485Medical Device Directive (Mdd 93/42/Eec)Semi-Automated Manufacturing Processes
Healthtech • Industrial • Manufacturing
Designs, prototypes, tests, and qualifies mechanical components for high-reliability medical devices. The engineer researches design options, develops manufacturing processes, manages tooling, supports product documentation and regulatory compliance, resolves production issues, evaluates nonconformances, and recommends design improvements. The role collaborates with global design and manufacturing teams while assisting senior engineers and supporting intellectual property development.
Top Skills:
SolidworksSolidworks Add-Ins
Healthtech • Industrial • Manufacturing
Leads cybersecurity engineering for connected medical devices across the product lifecycle. Responsibilities include security architecture, system threat modeling, regulatory requirement derivation, verification evidence, penetration testing, vulnerability assessment, remediation planning, interoperability security, and audit-ready documentation. The role coordinates with Systems, Software, Quality, and Regulatory teams while maintaining product security plans and supporting FDA, QMS, and medical device cybersecurity compliance.
Top Skills:
Aami Sw96CehCismCisspComptia Security+CveCvssFda Cybersecurity GuidanceFda QsrFirewallsIec 62443Iec 81001-5-1Iso 13485LinuxMitre Att&Ck For IcsNetworking ProtocolsNist CsfNvdPastaSbomStrideTaraWindows
Healthtech • Industrial • Manufacturing
Manage and improve electro-mechanical manufacturing processes, supporting production, quality, and product development teams. Responsibilities include process validation, tooling and test equipment design, automation, workflow optimization, failure investigations, CAPA activities, tolerance analysis, documentation, and design-for-manufacturing input. The role also supports new product introduction, prototype builds, quality-system compliance, and productivity improvements while applying Lean and Six Sigma principles.
Top Skills:
AutomationCanadian Medical Device RegulationsFda Quality System Regulation 21 Cfr Part 820Iso 13485Lean ManufacturingMedical Device Directive 93/42/EecPlc ProgrammingRoboticsSix Sigma
Healthtech • Industrial • Manufacturing
Leads a 6–10-person software engineering team developing applications for medical imaging devices. Oversees architecture, implementation, verification, validation, project delivery, agile processes, resource planning, and cross-functional collaboration. Mentors engineers, manages external development resources, and ensures compliance with medical-device standards. Defines software organization strategy, scales engineering capacity, and drives adoption of Generative AI to improve productivity, quality, innovation, and development efficiency.
Top Skills:
Arm Cortex-A/MEmbedded LinuxEmbedded RtosGenerative AiGitIec 62304Iso 13485Iso 14971Msp430Stm32SubversionX86/64
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