Development Mechanical Engineer

Overview

On Site
Full Time

Skills

Mechanical Engineering
Creo
GD&T
Report Writing
Statistics
Data Integrity
FMEA
Project Management
Communication
Minitab
Design Controls
ISO 13485
Verification And Validation
Test Plans
Reporting
Management
Change Management
Regulatory Compliance
ISO 9000
Risk Management
Manufacturing
Supply Chain Management
Technical Writing
Risk Assessment
Design Review

Job Details

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
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