Senior Engineer – Medical Device Development

Job SummaryWe are seeking an experienced Senior Engineer – Medical Device Development with strong hands-on expertise across the end to end medical device product development lifecycle, including design, documentation, verification & validation (V&V), and regulatory compliance.The ideal candidate will have deep experience working in regulated medical device environments and hands-on proficiency with QMS, PLM, requirements, and CAD tools such as MasterControl, Arena, Jama, and SolidWorks, in alignment with FDA, ISO 13485, and applicable IEC standards.______________Key ResponsibilitiesProduct Development & Engineering Lead and contribute to medical device design and development activities from concept through commercialization. Develop, review, and maintain design inputs, outputs, specifications, and technical documentation aligned with user needs and regulatory requirements. Perform CAD modeling, design updates, and engineering drawings using SolidWorks or equivalent mechanical CAD tools. Support design verification, validation, and risk management activities throughout the product lifecycle.Quality & Regulatory Compliance Ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable IEC standards. Author, review, and maintain Design History File (DHF), Device Master Record (DMR), and related technical documentation. Support internal and external audits, regulatory inspections, and submission readiness activities. Participate in change management, deviation investigations, and CAPA processes.Tools & Systems (Hands-On) Actively use and manage documentation and records within: MasterControl – QMS, document control, training, change management Arena PLM – BOMs, ECOs, configuration, and product lifecycle management Jama – requirements management and traceability matrices SolidWorks – mechanical design and engineering drawings Ensure end to end traceability across requirements, design, risk, and test artifacts.Cross-Functional Collaboration Work closely with Quality, Regulatory Affairs, Manufacturing, R&D, and Clinical teams. Collaborate with suppliers and manufacturing partners to support DFM/DFA and production transfer. Support technology transfer, scale up, and manufacturing readiness activities.______________Required QualificationsEducation Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline. 5–10 years of hands-on experience in medical device development. Proven experience working in regulated (GxP) environments. Direct, hands-on experience with: MasterControl Arena PLM Jama SolidWorks Experience with design controls and risk management (ISO 14971).Technical Skills Strong understanding of: Design Controls & DHF management Requirements traceability Verification & Validation (V&V) Change control and configuration management Familiarity with tools such as Altium, Windchill, Teamcenter, Minitab, IBM DOORS, or Veeva Vault is a plus.______________Soft Skills & Competencies Strong analytical and problem-solving skills Excellent documentation and technical writing abilities Ability to work independently and in cross-functional teams Strong communication skills with stakeholders and leadership High attention to detail with a compliance-focused mindset