Development Mechanical Engineer

2 weeks ago

Broadview Heights, Ohio, United States Katalyst CRO Full time

Summary

  • 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 Client Biomet Development experience required.

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.

Education & Experience

  • Experience Required years

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