Katalyst CRO · 1 month ago
Product Development Engineer – Medical Device
Broadview Heights, OH
Full-time
Onsite
Mid Level
4+ years expKatalyst CRO is a company specializing in medical device development, and they are seeking a Product Development Engineer to lead product development for orthopedic implants and instruments. The role involves authoring test protocols, ensuring regulatory compliance, and collaborating with manufacturing and suppliers 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
Proficiency in CAD (Solid Works Creo), GDT, tolerance analysis, and fixture design
Knowledge of orthopedic testing standards (ASTM F382, F543, F1717, F2077, ISO 1424214243, etc.)
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)
Experience with external lab management, including protocol alignment, fixture approval, deviation handling, and report review
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
4–6 years of experience in Supplier Quality or Product Quality Engineering in medical device industry
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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