R&D Mechanical Engineer

Job Description

We are seeking an experienced Mechanical Engineer with expertise in medical device design controls to support the design, documentation, and compliance strategy for medical devices intended for the U.S. market. In this role, you will apply a strong engineering foundation and hands-on experience with design requirements across the full product lifecycle. You will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams to ensure products meet technical performance expectations and global regulatory requirements.

Responsibilities

• Lead and support remediation design activities for medical devices in accordance with FDA design control requirements and applicable standards.
• Conduct engineering studies, testing, and technical evaluations to ensure design controls are aligned with regulatory requirements.
• Generate comprehensive technical documentation, including design inputs and outputs, risk analyses, V&V protocols, and test reports.
• Perform and maintain risk management activities in alignment with applicable ISO standards.
• Lead or support FMEA, fault-tree analysis, and other risk assessment activities to identify and mitigate product risks.
• Collaborate with Quality to ensure design documentation, DHFs, and updates meet internal SOPs and external regulatory standards.
• Contribute to project planning, including schedule development, resource estimation, and technical decision-making.
• Design and execute verification and validation testing to demonstrate product safety, performance, and regulatory compliance.
• Lead investigations of design issues, CAPAs, and nonconformances impacting EU and other global markets.
• Partner cross-functionally with Regulatory, Clinical, Manufacturing, and Quality teams to integrate design changes and compliance activities into development and production.

Essential Skills

• Bachelor’s or Master’s degree in Mechanical, Biomedical, Electrical, or a related engineering field.
• R&D experience within the medical device industry, including direct involvement in product design and development.
• Strong understanding of FDA design controls and applicable ISO/IEC standards.
• Experience conducting engineering studies, testing, and technical evaluations in a regulated environment.
• Demonstrated ability to generate audit-ready documentation, including design inputs/outputs, risk analyses, and V&V protocols and reports.
• Strong technical writing and documentation skills.
• Hands-on experience with medical device risk management, including FMEA and fault-tree analysis.
• Ability to collaborate effectively with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing.
• Strong problem-solving skills with experience investigating design issues and supporting CAPAs.

Additional Skills & Qualifications

• Experience with Class IIb or Class III medical devices.
• Proficiency with SolidWorks.
• Experience with Windchill or a similar PLM system.
• Familiarity with IEC standards for medical electrical equipment safety.
• Strong mechanical engineering and medical device design background.
• Experience contributing to project planning and schedule development within an R&D environment.