Senior Product Development Engineer

About the position

Moximed is seeking a Senior Product Development Engineer to join our team. The Senior Engineer will work within our regulated quality system environment to further develop Moximed's joint unloading technology embodied by the MISHA Knee System cleared by the FDA. In this role you will be working with cross-functional groups. Your role will be essential in developing product improvements and verifying/validating changes against intended use, user needs, and product requirements. Must enjoy the team approach over individual contributions. Experience with product development after design transfer to production is required.

Responsibilities

• Build on current product and joint unloading technology following design control procedures and principles.
• Work within a lean, focused R&D group and manage/collaborate with cross-functional team members to achieve milestones.
• Analyze and interpret customer feedback, complaints, and retrieved products to drive and support product development activities.
• Collect data to support the business case and design input for development projects, including root cause analysis, cost estimates from suppliers, and meetings with end-users.
• Integrate cross-functional groups early in the development and provide consistent updates.
• Create and perform engineering validations and verifications, including challenging existing tolerances and conducting mechanical and packaging testing.
• Perform risk-based assessments as part of development activities, including developing and executing biocompatibility evaluation plans.
• Prepare and present technical and end-of-phase design reviews to cross-functional group members.
• Maintain accurate documentation including test protocols, reports, and engineering assessments to support quality system and regulatory requirements.
• Suggest, contribute, and champion initiatives to improve R&D, design control, and change control practices.
• Hands-on work with cadavers and in an OR setting to inform on the development and refinement of hand-held surgical instruments and minimally invasive surgical techniques.
• May require up to 20% travel to visit suppliers, end-users, etc.
• Other responsibilities may be assigned to meet the needs of Moximed.

Requirements

• Bachelor's Degree in mechanical engineering or equivalent discipline preferred.
• 5+ years of medical device product development experience is required, with preference given to orthopaedic medical device development.
• Excellent SolidWorks knowledge, good CAD practices, and skills for the creation and revision of parametric models and ASME Y14.5 compliant engineering drawings.
• Ability to interpret and perform tolerance stack-up analyses.
• Advanced knowledge of MS Office computer required; knowledge of MS Project preferred.
• Proven history of leading design verification, design validation, test method validation, and/or process validation (IQ/OQ/PQ) testing required.
• Knowledge of descriptive statistics and sampling methodology is required at minimum.
• Well versed in ISO 14971 hazard analysis; experience with creating dFMEA and/or uFMEA to inform hazard analysis desirable.