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Katalyst CRO · 1 month ago

R&D /Product Development Engineer

Cleveland, OH

Contract

Onsite

Mid, Senior Level

Katalyst CRO is a company focused on product development in the orthopedic field. They are seeking an R&D/Product Development Engineer to lead product development for orthopedic implants, ensuring compliance with regulatory standards and managing external lab relationships.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Proficiency in CAD (SolidWorks/Creo). GD&T tolerance analysts, 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. 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

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

Qualification

CAD (SolidWorks/Creo)Orthopedic testing standardsTest protocol/report writingMaterialsProcesses knowledgeDesign controls ISO 13485Design controls ISO 14971Risk management tools DFMEARisk management tools EMEACross functional communicationProject management

Required