Product Development Engineer I

Paragon 28’s growth continues and we’re looking for more great employees! Now is your chance to join this public company dedicated to improving a patient’s quality of life with the treatment of the most challenging foot and ankle conditions! We are currently looking to fill the position ofProduct Development Engineer I with a starting range of $66,000 - $85,000/year, dependent upon experience, education, and skills.Thisposition requires a full-time onsite presence.

The Product Development Engineer I has responsibility 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.

Key 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

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

P28 is a leader in the development and distribution of medical solutions for the foot and ankle industry. Established in 2010,every member of our inspired and dedicated team serves a vital role in the achievement of our mission: to strategically build a company around the core principles that drive innovation and quality. We're located at 14445 Grasslands Dr., just off E-470 and Peoria St. on the east side of Englewood, CO.

We offer comprehensive medical coverage with generously subsidized premiums for both employees only and coverage with dependents. Plans include prescription drug and behavioral health coverage as well as telemedicine services. Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness), pet insurance and more. Free counseling services and resources are offered for emotional, physical, and financial wellbeing through our Employee Assistance Program. A safe harbor 401(k) Plan with 3% match and an Employee Stock Purchase Plan, which allows purchase of P28 stock at a discounted rate. You are able to accrue 19 days of PTO over 12 months to maintain a fulfilling work/life balance. Our working environment is considered Colorado Casual. Onsite we have a fresh food kiosk, free parking and will have a new, expanded fitness center!

Paragon 28 is an equal opportunity employer and values diversity. All employment decisions are decided on the basis of qualifications, merit and business need.

Notice to Recruiters and Staffing Agencies: to protect the interests of all parties, Paragon 28, Inc. will not accept unsolicited resumes or referrals from any source other than directly from a candidate or an approved vendor that has a written and signed agreement in place through the Paragon 28, Inc. HR department. Please do not contact or forward resumes or referrals to our company employees. Any unsolicited resumes will be considered Paragon 28, Inc. property. Paragon 28, Inc. is not responsible for any charges or fees related to unsolicited resumes or referrals.