Project Engineer- Biomedical Design

• Industry Biomedical Engineering, Medical Device Design Consulting
• Employee Type Full Time Exempt
• Required Degree 4 Year Degree
• Manage Others No

• 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

• 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
• 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 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.

We are currently seeking a self‑motivated, charismatic individual to join our product development engineering team. A successful candidate for this position possesses exceptional technical skills and understanding related to working in the highly regulated medical device industry. This individual will have direct support from leadership and team members through training and continuous learning. We offer a very competitive salary, commensurate with the role and your experience as well as an attractive, comprehensive benefits package.

If you ’re looking for an autonomous career opportunity while working in a transparent and positive culture that promotes professional growth and teamwork, we’d love to hear from you!

• Benefits:
  Medical, Dental, Vision, Life Insurance, 401(k) match, generous PTO, 12 Paid Holidays, Wellness Program with Fitness Center and Training Classes, Flexible Schedule, remote work from home days
• Company cell phone and laptop
• Training and support in developing your understanding of medical device development, regulatory affairs, and quality management systems
• Exciting, fast‑paced, and team‑oriented culture with fun company outings and team building activities
• Great opportunity to get in on a growing, enthusiastic company and establish yourself as a long‑term key member