Senior Engineer – Medical Device Development

We 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 Responsibilities
Product 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:
o             MasterControl – QMS, document control, training, change management
o             Arena PLM – BOMs, ECOs, configuration, and product lifecycle management
o             Jama – requirements management and traceability matrices
o             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 Qualifications
Education
•              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:
o             MasterControl
o             Arena PLM
o             Jama
o             SolidWorks
•              Experience with design controls and risk management (ISO 14971).

Technical Skills
•              Strong understanding of:
o             Design Controls & DHF management
o             Requirements traceability
o             Verification & Validation (V&V)
o             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