Description

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 of Sr. Product Development Engineer - Patient Specific with a starting range of $85,000 - $110,000/year, dependent upon experience, education, and skills.

This position requires a full-time onsite presence.

The Sr. Product Development Engineer leads the design of new products and improvements to existing products and systems, as part of a project team. This role also develops new product designs with firm grasp on design for manufacturing and customer need.

Key Responsibilities

Lead product development efforts from ideation to commercialization through entire product life cycle, as part of a team, including:
Research and evaluate products, parts, processes for efficiency and reliability
Conceptualization of new design ideas while understanding the inadequacy of existing designs.
Parametric modeling and detail design of P28 implant and instrument development with a firm grasp on design for manufacturing
Assist junior Engineering staff with modeling and detailing methodology
Lead efforts of new product development in design control, including the management and implementation of P28 design history files.
Lead design efforts to minimize patient risk and adhere to regulatory requirements
Lead in development of testing protocols and assist in the testing process for new and existing products
Analyze test results and recommend appropriate design changes
Formulate complete test strategies and test reports with R&D and regulatory. Work with Marketing to determine how data or analysis could be used for education or as selling tool in abstract/poster or white paper.
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.
Lead surgical demonstrations (live, cadaver, or video) on lower extremity pathology and formulate physician comments/ideas into meaningful design solutions.
Provide sales support via phone and live training as expert technical resource within specific product categories.
Compile invention disclosures for patent applications and infringement evaluations
Participate in root cause analysis and corrective action development for design related issues in released product
Assist with other development projects as additional resource when needed, while balancing own workload
Other duties as directed by manager

Non Essential Responsibilities and Duties

Participate in clinical research projects or clinical trials.
Assist/ aide in skills development of junior engineers including:
Design for manufacturing
Develop testing strategies
Implementation of design control documentation
Validation and verification planning.

Qualifications

Requires a bachelor's degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline with 6+ years of experience

Prior experience in medical device development required.
Prior experience in taking a medical device or similar product from ideation to commercialization required.
Ability to read and interpret documents such as drawings, engineering specifications, testing standards, regulatory guidance documents, safety rules, company policy and procedure manuals.
Demonstrated ability to lead projects l autonomously as part of a cross-functional team (Supply Chain, Marketing, Quality, Regulatory, etc.) and deliver updates to senior management.
Experience with designing for manufacturability, inspection and assembly.
Proficient with design control activities and verification and validation activities with respect to medical device development.
Understanding of medical device industry regulatory requirements required.
Proficient 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.

Average Compensation: $122,338

How Much Do Paragon 28, Inc. Employees Make?

High-paying Jobs at Paragon 28, Inc.