Sr. Product Development Engineer
As a key team member, you will participate in the development process from concept and ideation through commercialization for client companies. Your role will include leading the development of concepts, prototypes, processes, and products from initial design to release, managing smaller projects, and ensuring the successful execution of deliverables.
Key Duties and Responsibilities:
Lead the design and development of medical devices from concept through to market release.
Create and refine product designs, including CAD models and technical documentation.
Conduct feasibility studies and risk analysis to ensure design functionality and safety.
Collaborate with cross-functional teams and external suppliers to meet project timelines.
Oversee validation activities, including Design Verification and product testing.
Ensure compliance with FDA QSR, ISO 13485, and other relevant regulations.
Communicate project progress and technical details to stakeholders.
Mentor junior engineers and participate in design reviews.
Education, Experience, and Skills:
- Experience with medical device design and development.
- Experience in design for catheters and extrusions required.
- Experience in design for reinforced shaft, delivery systems, and steerable catheters required.
- Bachelor's degree in Mechanical or Biomedical Engineering (or equivalent experience).
- Proficiency in SolidWorks 3D CAD.
- Familiarity with FDA QSR and ISO 13485 medical device regulations.
- Depth of knowledge in one or more technical areas (e.g., laser/resistance welding).
- Knowledge of probability and statistics.
- Demonstrated ability to bring products from concept to market.
- Ability to interact with clients professionally and maintain customer focus.
$40-$60/hour