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R&D /Product Development Engineer

Katalyst Healthcares & Life Sciences10 months ago
Cleveland, OH, United States
Hybrid
Full-time
Junior Level (1-3 years)
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Job Description

Key Responsibilities

  • Proficiency in CAD (SolidWorks/Creo), GD&T tolerance analysis, and fixture design.
  • Knowledge of orthopedic testing standards (ASTM F382, F543, F1717, F2077, 150, 14242/14243, 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, stainless steel, UHMWPE, PEEK, AM, and 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.
  • Competency in risk management tools (DFMEA, EMEA) and traceability from requirement to verification.
  • Project management and cross-functional communication using tools like MS Project and Minitas.

Required Qualifications

  • 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 regulatory compliance and risk-based acceptance criteria.
  • 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, simulated use, and preclinical testing.
  • Collaborate with manufacturing and suppliers for DFMA process validations and design transfer readiness.

Required Skills

Project management
Cross-functional communication
Orthopedic testing standards (ASTM F382, F543, F1717, F2077, ISO 14242/14243)
Statistical analysis (95/95, tolerance intervals)
Design verification and validation (DV&V)
MS Project
Risk management tools (DFMEA, EMEA)
Materials and processes (Ti alloys, stainless steel, UHMWPE, PEEK, AM, coatings)
Design controls (ISO 13485, ISO 14971)
Fixture design
External lab management
Minitas
Test protocol and report writing
Regulatory pathways (510(k), PMA, MDR)
CAD (SolidWorks/Creo)
GD&T tolerance analysis