Product Engineer-5

Product Engineer
Location: Broadview Heights-OH
Duration: 6 months
Technical Functional Skills Proficiency in CAD (SolidWorksPTC Creo), GDT, tolerance analysis, and fixture design. Strong capability in test protocol report writing, statistical analysis (9595, tolerance intervals), and data integrity practices. Familiarity with materials and processes Ti alloys, CoCr, stainless steel, UHMWPE, PEEK, AM, coatings. Understanding of design controls, ISO 13485, ISO 14971, and regulatory pathways (510(k), PMA, MDR). Competence in risk management tools (DFMEA, pFMEA) and traceability from requirements to verification. Skilled in project management and cross-functional communication, using tools like MS Project, Minitab.

Prior Zimmer Biomet Development experience required.
Experience Required2 - 4 years Roles Responsibilities
Lead DHHRMF Build activities, ensuring adherence to design control requirements per ISO 13485 and FDA 21 CFR Part 820.Execute Design Verification and Validation (DVV) protocols, including test planning, execution, and reporting.
Manage Change Management processes in compliance with ISO 14971 risk management and internal quality procedures.
Coordinate project activities across cross-functional teams (Quality, Regulatory, Manufacturing, and Supply Chain).Create and maintain technical documentation Design History File (DHF), risk assessments, and engineering reports
.Support Design Reviews and ensure traceability of requirements throughout the product lifecycle.