Development Mechanical Engineer

Broadview Heights, OH, US • Posted 60+ days ago • Updated 20 minutes ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

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

Summary

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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: f1382c85b726d921a54ee40796bca1f5
  • Posted 30+ days ago
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