Katalyst CRO · 2 months ago
Validation design
Cleveland, OH
Contract
Onsite
Mid, Senior LevelKatalyst CRO is focused on product development for orthopedic implants and instruments. The role involves leading product development from concept to design transfer, ensuring compliance with standards, and collaborating with various stakeholders throughout the project lifecycle.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead product development for orthopedic implants and instruments from concept through design transfer
Author and execute test protocols and reports per ASTMISO 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 (DVV) including benchtop, simulated use, and preclinical testing
Collaborate with manufacturing and suppliers for DFMA, process validations, and design transfer readiness
Qualification
Required
Lead product development for orthopedic implants and instruments from concept through design transfer
Author and execute test protocols and reports per ASTMISO 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 (DVV) including benchtop, simulated use, and preclinical testing
Collaborate with manufacturing and suppliers for DFMA, process validations, and design transfer readiness
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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