Katalyst CRO ยท 1 month ago
New Product Introduction (NPI) Process Engineer
Santa Clarita, CA
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is a company focused on contract research and development. They are seeking a New Product Introduction (NPI) Process Engineer to manage prototype and pilot builds, ensuring compliance and effective collaboration with manufacturing and quality teams.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Manage prototype and pilot builds for new product introduction, including operator training and coordination with production planning
Collaborate cross-functionally with Manufacturing and Quality teams to ensure process adoption and compliance
Apply Design for Manufacturability (DFM) principles to tooling, process design, and product integration
Support the R&D team with Design Verification (DV) testing and technical reporting
Plan and execute Process Validations (IQ/OQ/PQ) for product launch
Conduct Packaging Validations for new products
Develop and implement procedures for Receiving Inspection, First Article Inspection, and Automated Test Equipment (ATE) setup
Troubleshoot and sustain ATE processes
Contribute to Process Failure Mode and Effects Analyses (pFMEAs) in collaboration with Manufacturing Engineering
Qualification
Required
35 years of experience in manufacturing process development and sustaining engineering
Background in medical device manufacturing, including implantable and Class II/III devices
Interpret engineering drawings, BOMs, and tolerance stack-ups
New Product Introduction (NPI), design verification, and process validation
Experience developing and executing IQ/OQ/PQ protocols
Knowledgeable in product lifecycle transitions and DFM principles
Preferred
Proficiency in SolidWorks CAD
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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