Katalyst CRO

Compensation

Full Description

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 - 4 - 6 years