Senior Medical Device Engineer

4 weeks ago


San Diego, California, United States Resonetics Full time
Job Summary:

Resonetics is seeking a highly skilled Senior Medical Device Engineer to join our team. As a key member of our cross-functional engineering team, you will be responsible for driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.

Key Responsibilities:

Summarize and refine product specifications
Brainstorm novel therapeutic concepts
Perform concept refinement and generate detailed CAD design
Prototype and evaluate catheter-based designs
Perform engineering calculations, including tolerance analysis
Draft complex drawings with a demonstrated understanding of component manufacturing methods
Develop in-vitro test methods, including fixture design and fabrication
Perform in-vivo and in-vitro study protocol development, execution, reporting
Develop manufacturing processes and documentation
Create and maintain designs controls documentation
Generate product risk analyses
Lead customer meetings and communicate directly with clients in a timely and professional manner

Requirements:

A minimum of 7 years experience in medical device product design and development. Strong project management experience leading cross-functional teams in a technical environment. Strong analytical and data-driven approach with proven problem-solving abilities. Strong presentation, written, and verbal skills. Ability to communicate with all levels within the organization. Solid team leadership, team building, and facilitation skills. Demonstrated mediation skills and ability to resolve apparently conflicting requirements through effective communication. Ability to facilitate a collaborative working environment for customers and team members. Comfort communicating and/or presenting in front of clients and large project teams. Ability and willingness to travel. Close familiarity with FDA QSR and ISO 13485 medical device regulations. Experience in all phases of the medical device product development lifecycle.

Compensation:

$125,000-145,000

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