Project Engineer- Biomedical Design

Description

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

Requirements

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

This position will involve all aspects of product design and project management including, but not limited to, client consultation, vendor selection and management, marketing support, and post-market surveillance.