Senior Product Development Engineer

Company DescriptionTreace's mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers' expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job DescriptionWe are seeking an experienced and driven Senior Product Development Engineer to lead the commercialization of innovative medical devices in the foot and ankle industry. This role is ideal for individuals who thrive on tackling challenges and find fulfillment in delivering new products that meet the highest standards of efficacy.

As part of this role, you will collaborate across multidisciplinary teams and work directly on developing mechanical devices for surgical use. Your expertise will be key in driving design refinements, ensuring compliance with regulatory and quality standards, and successfully launching groundbreaking solutions designed to improve patient outcomes.

What you would be responsible for: Commercialization Leadership•Lead the coordination and execution of all activities for the successful launch of medical devices in a timely manner.

Design Evaluation•Evaluate design performance, uncover refinements, and improve the manufacturing processes without compromising functionality.

Engineering Specifications•Formulate engineering drawings and specifications to maintain product stability while minimizing inspection burdens.

Analysis•Analyze tolerance stack-up effects to ensure precise manufacturing.

Documentation•Develop and maintain comprehensive engineering rationales, risk assessments, and V&V (Verification & Validation) testing protocols/reports in compliance with internal and external standards.

Collaboration•Work closely with Quality, Regulatory, Operations, and Marketing teams to ensure project goals are clear, purposeful, and well-supported.

Stakeholder Feedback•Gather valuable user and stakeholder input to refine designs and improve functionality.

Communication•Foster efficient information flow to prevent unnecessary time and effort.

Travel and Availability•Ability to travel (15% of the time, including out-of-town labs, surgeries, and supplier visits) and occasionally work on weekends as needed.

Key QualificationsStrong leadership and project management skills in medical device development.

Technical expertise in mechanical design for surgical applications.

Ability to adapt to challenges, rapidly learn design intent, and implement manufacturing improvements.

Outstanding collaboration skills to work effectively within cross-functional teams.

Attention to detail and precision in developing engineering specifications and documentation.

QualificationsBachelor's degree in Mechanical Engineering or equivalent engineering discipline.4+ years' mechanical design and manufacturing experience.

Additional InformationAll your information will be kept confidential according to EEO guidelines.

Treace's Privacy PolicyIt is Treace's policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer Treace is a drug free employer.