Intellectt Inc

New Product Development Engineer

Posted: 7 hours ago

Job Description

Hi, Intellectt Inc is looking for NPD Engineer on W2 Contract role for its Med/Pharma Client. If interested then we encourage you to apply.Position:: New Product Development Engineer(NPD Engineer)Location :: Columbus, Ohio (Day 1 onsite)Duration :: 6-12 monthsNo benefitsJob description ::Proficiency in CAD (SolidWorks/Creo). GD&T tolerance analysts, and fixture design.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 verificationproject management and cross functional communication, using tools like MS Project, MinitasLead 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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