Senior NPI Engineer, Medical Devices — End-to-End Leader

elemed; Santa Barbara (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

elemed is seeking a Senior Product Development Engineer to lead end‑to‑end medical device development from concept through market launch. You will work closely with leadership to shape innovation, manage design controls, and drive risk management across projects.

The role offers freedom to shape new devices with colleagues across regulatory, quality, and manufacturing, with growth into leadership and potential direct reports as the product line expands.

Qualifications

• Eight or more years of product development experience in the medical device industry.
• Experience with design controls, risk management processes, and regulatory standards.
• Proficiency in SolidWorks for 3D modelling and technical drawings.
• Legally authorized to work in the United States without visa sponsorship.

Responsibilities

• Lead cross‑functional product development projects end‑to‑end, ensuring on‑time delivery and meeting quality standards.
• Translate clinical and customer needs into structured design requirements and drive risk management and design reviews.
• Build and evaluate prototypes with various materials, develop drawings, select materials, and liaise with suppliers to reach manufacturability.
• Design and execute process characterization and verification activities, including test methods and fixture design for regulatory submissions.
• Collaborate with clinicians, marketing, regulatory, quality and manufacturing to assess new technologies and production feasibility.
• Contribute to intellectual property activities, including invention disclosures and patent strategy discussions.
• Support design and process changes post‑launch, resolve technical issues, and drive continuous improvement.
• Mentor and develop junior engineers, acting as a technical reference for the team.

Skills

Product development

Design controls

Risk management

Regulatory standards

Mentoring

Tools

SolidWorks

Job description

elemed is seeking a Senior Product Development Engineer to lead end‑to‑end medical device development from concept through market launch. You will work closely with leadership to shape innovation, manage design controls, and drive risk management across projects.

The role offers freedom to shape new devices with colleagues across regulatory, quality, and manufacturing, with growth into leadership and potential direct reports as the product line expands.