Senior Engineer – Product Development Engineering

About the role

We are seeking a Senior Engineer to lead design and development of medical devices throughout their lifecycle. The role involves close collaboration with customers, project managers and cross‑functional teams to deliver innovative, compliant products.

Key responsibilities

• Create technical execution plans and deliverables in partnership with project managers.
• Lead design, development and validation activities, ensuring milestones are met.
• Interact with customers to tailor technical solutions to their needs.
• Generate concepts, solve technical problems and make decisions on vendors, critical‑to‑quality items and design choices.
• Mentor engineers, technicians and less‑experienced staff to reduce execution risk.
• Oversee documentation for requirements, design output, verification and testing in accordance with ISO 13485 and company QMS.

Required profile

• Bachelor’s degree in Engineering (Mechanical Engineering preferred); Master’s degree is a plus.
• Minimum 5 years of experience in the medical‑device industry, with additional engineering experience preferred.
• Strong knowledge of product development, testing, modeling and process validation.
• Familiarity with ISO 13485 design control and process validation documentation.
• Ability to communicate complex technical concepts clearly to diverse audiences.

Required skills

• SolidWorks
• Six Sigma Green Belt or Black Belt