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Project Engineer- Biomedical Design
Job in
Westlake, Cuyahoga County, Ohio, 44145, USA
Listed on 2026-03-03
Listing for:
Thogus
Full Time
position Listed on 2026-03-03
Job specializations:
-
Engineering
Biomedical Engineer, Product Engineer
Job Description & How to Apply Below
Essential Responsibilities:
- Leads and/or participates in project teams for the design and development of medical devices.
- Develops and maintains Design History Files in accordance with client procedures and regulations
- Interfaces with clients to define and achieve design objectives
- Proactively works with all parties throughout the product development lifecycle to successfully achieve milestones
- Interfaces with quality, operations, and external vendors to ensure manufactured products meet design intent
- Compiles, prepares, and presents information for project updates and technical presentations
- Assists in resolving complex engineering problems and providing sound solutions to clients
Qualifications:
- Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, or similar discipline
- Minimum 4 years of related work experience in the medical device industry (spine/orthopedic experience preferred)
- Extensive 2D/3D CAD design experience in Solidworks, Siemens NX, or similar software
- Experience with Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 and designing components for manufacturability
- Ability to coordinate the manufacturing of design prototypes and production parts with external vendors
- Familiarity with verification and validation testing of medical devices
- FEA (Finite Element Analysis) experience a plus
- Experience designing products in a regulated environment including FDA, EU/MDR, ISO, and other relevant regulations
- Understanding of the phases of medical device development in accordance with regulations and industry standard practices
- Excellent interpersonal and written communication skills
- Ability to multitask and efficiently manage multiple projects
- Candidate must be a self-starter, self-motivated, and results-oriented
- Able to work both independently and have with cross-functional teams
- Extensive project management skills with the ability to work against tight timelines
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