Product Development Engineer I

Paragon 28, Inc.•Englewood, CO

6d•$80,000 - $105,000•Hybrid

About The Position

Passionate about innovation in foot and ankle orthopedics? Paragon 28, a Zimmer Biomet company, is hiring an experienced Product Development Engineer I (E2) to support our fast-moving R&D team. The Product Development Engineer I has at least 2 years of professional experience and is responsible for leading various aspects of design and development as part of a project team with direct supervision. This position participates on meaningful projects that focus on design and development of medical devices with increasing levels of autonomy. This position is a hybrid role based our of our Englewood, Colorado location.

Requirements

Requires a bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline with 2-4 years of experience.
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

Prior experience in medical device development helpful.
Experience in taking medical device or similar product from ideation to commercialization helpful.
Understanding of medical device industry regulatory requirements preferred.

Responsibilities

Produce deliverables in support product development efforts from ideation to commercialization through entire product life cycle and on a given timeline, as directed by senior engineering staff, including: 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 and technical 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
Participate in 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
Observe surgery (live, cadaver, or video) on lower extremity pathology and formulate physician comments/ideas into meaningful design solutions. Document all notes.
Work to become 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