Overview
On Site
Full Time
Skills
Research and Development
SolidWorks
Creo
GD&T
Report Writing
Statistics
Data Integrity
ISO 13485
Management
Reporting
FMEA
EMEA
Project Management
Communication
Product Development
Regulatory Compliance
Test Execution
Logistics
Design Controls
Risk Management
ISO 9000
Project Lifecycle Management
Verification And Validation
DV
Testing
Collaboration
Manufacturing
DFMA
Job Details
Roles & Responsibilities:
- Proficiency in CAD (SolidWorks/Creo). GD&T tolerance analysts, and fixture design.
- Knowledge of orthopedic testing standards (ASTM F382 F543, F1717. F2/14243, etc.).
- Strong capability in test protocol/report writing statistical analysis (95/95, tolerance intervals), and data integrity practices.
- Familiarity with materials and processes: Ti alloys. Coctainless steel UHMWPE, PEEK. AM. coatings.
- Understanding of design controls ISO 13485, ISO 14971, and regulatory pathways (510(k), PMA. MDR).
- Experience with external lab management, including protocol alignment, fixture approval, deviation handling and report review.
- Compete in risk management tools (DFMEA EMEA) and traceability from requirement to verification
- project management and cross functional communication, using tools like MS Project, Minitas
- Pro Client met Development experience required
- Lead product development for orthopedic implants and instruments from concept through design transfer Author and execute test protocols and reports per ASTM/ISO standards, ensuring risk-based acceptance criteria and regulatory compliance.
- Act as primary liaison with testing labs: prepare technical data packages, approve fixtures, clarify protocol details, and ensure proper sample handling and chain-of- custody.
- Support lab test execution by coordinating logistics reviewing set-up photos/videos, witnessing critical tests, and resolving deviations promptly.
- Maintain design controls and risk management per ISO 14971 and 21 CFR 820 throughout the project lifecycle.
- Plan and perform design verification and validation (DV&V) including benchtop. smulated use, and preclinical testing.
- Collaborate with manufacturing and suppliers for DFMA process validations, and design transfer readiness.
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