Our client is a consulting company that is focused in the medical device industry. They provide consulting services for product development, with a heavy emphasis on pre-market work. This person will be a project leader for the design and development of medical devices, and serve as a company representative for defined phase within scope of work.
This position is a full time, salaried role with full corporate benefits and offers a fast-growth career opportunity that you will rarely see in the industry.
This is a small team of tenured Engineers and Regulatory Affairs SMEs who work closely together. You will work hand in hand with clients and consulting services team members, in helping to devise and execute business objectives. This is an environment that fosters professional development, engineering excellence and a creative approach to the industry’s toughest product design challenges.
Are you an Engineer looking to gain breadth of skills and knowledge, working with a variety of technologies without having to change jobs?
Do you enjoy a small, family-like environment where people help each other be their best? (and offers a chance to work remotely)?
If so, this is the opportunity for you! Apply now to learn more about how you can catapult your career in the industry!
Responsibilities:
Proactively work with all parties throughout the product development lifecycle to successfully and achieve milestones
Interface with quality, operations, and vendors to ensure manufactured products meet design intent
Create and maintain device history files per FDA, ISO and other regulations
Compile, prepare and present information for project updates and technical presentations
Assist in resolving complex engineering problems and provide sound solutions to clients
Qualifications:
-Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, or similar field.
-Minimum 4 years related work experience in the medical device industry
-Extensive 2D/3D CAD design experience, including expertise in Geometric Dimensioning and Tolerancing (GD&T) and design for manufacturability
-Ability to coordinate the manufacturing of design prototypes and production parts
-FEA (Finite Element Analysis) experience a plus
-Experience designing products in a regulated environment including FDA, ISO and other regulations
