Senior Medical Device NPI Lead

elemed; Santa Barbara (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Elemed is seeking a Senior Product Development Engineer to own end-to-end development of medical devices from concept through market launch. You will work with leadership to shape new device programs, leveraging SolidWorks and material knowledge to deliver manufacturable and clinically relevant products.

Expect growth into leadership roles as the NPI function expands. The role emphasizes hands-on design, collaboration across disciplines, and contributions to IP strategy, with a focus on

Qualifications

• Eight or more years of product development experience in the medical device industry, with a track record of moving concepts through design controls to market.
• Demonstrable command of design control processes, risk management frameworks, and regulatory standards for medical device development.
• Strong proficiency in SolidWorks for 3D modelling and technical drawing of medical devices.
• Legally authorised to work in the United States without visa sponsorship.

Responsibilities

• Lead cross-functional product development projects end-to-end, ensuring deliverables and quality requirements are met.
• Translate clinical and customer needs into design requirements, drive risk management and verification activities.
• Build and evaluate prototypes, develop drawings and specs, and collaborate with suppliers to manufacturable designs.
• Design and execute process characterization and verification activities, including test method development.
• Collaborate with clinicians, regulatory, quality, and manufacturing to assess new technologies.
• Contribute to intellectual property discussions and invent disclosures.
• Mentor junior engineers and provide technical guidance.

Skills

Project leadership

Cross-functional collaboration

Regulatory knowledge

Risk management

Tools

SolidWorks

Job description

Elemed is seeking a Senior Product Development Engineer to own end-to-end development of medical devices from concept through market launch. You will work with leadership to shape new device programs, leveraging SolidWorks and material knowledge to deliver manufacturable and clinically relevant products.

Expect growth into leadership roles as the NPI function expands. The role emphasizes hands-on design, collaboration across disciplines, and contributions to IP strategy, with a focus on