Job Summary
We are seeking an experienced Senior Engineer Medical Device Development with strong hands-on expertise across the endtoend 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.
Required Qualifications
Education
- Bachelor s or Master s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline.
Experience
- 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
- 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
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:
- 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 endtoend 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, scaleup, and manufacturing readiness activities.
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