Product Development Engineer II (E3)

Paragon 28, Inc.•Englewood, CO

6d•$80,000 - $100,000•Onsite

About The Position

This role is for a Product Development Engineer II (E3) to join the R&D team at Paragon 28, a Zimmer Biomet company, in Englewood, Colorado. The position offers the opportunity to lead key aspects of the design life cycle for projects that restore mobility and change lives. The engineer will collaborate with a world-class project team to solve complex orthopedic challenges and develop cutting-edge medical solutions. As expertise is demonstrated, the role offers increasing autonomy to drive innovation and shape the product portfolio. The company emphasizes purpose-driven work, professional growth, and a collaborative culture in a fast-paced R&D environment.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline.
3-7 years of development experience in medical device.
Prior experience in taking medical device from ideation to commercialization required.
Experience with CAD. SolidWorks preferred.
High proficiency in MS Office.
Effective communication and presentation skills with ability to convey information and respond to questions from groups of peers.
Ability to work in a team environment.

Nice To Haves

Understanding of medical device industry regulatory requirements preferred.

Responsibilities

Produce deliverables in a product development leading role from ideation to commercialization through entire product life cycle and on a given timeline, as directed by senior engineering staff.
Research and evaluate competitive product for performance characteristics.
Conceptualization of new design ideas with some understanding of the inadequacy of existing designs.
Parametric modeling and detail design of P28 implant and instrument development.
Work within the P28 product development procedure to create design control documentation for P28 design history files.
Participate in development of testing protocols and assist in the testing process for new and existing products.
Compile and comprehend test results and implement/recommend appropriate design changes.
Lead activities related to project phase gate design reviews.
Interface with 3rd party suppliers, contractors, testing houses, etc.
Assist the P28 Quality and Supply Chain departments to evaluate new suppliers for inclusion in the P28 approved supplier list.
Assist P28 Quality team in developing inspection plans.
Aide in publication efforts with Clinical Affairs team.
Observe surgery (live, cadaver, or video) on lower extremity pathology and formulate physician comments/ideas into meaningful design solutions. Document all notes.
Serve as technical expert resource within specific product categories for Sales Support and other departments via phone and live product training.
Assist on patent application preparation.
Assist with other development projects as additional resource when needed, while balancing own workload.
Other duties as directed by manager.