Katalyst CRO · 1 month ago
CNC Manufacturing Engineer
Warsaw, IN
Contract
Onsite
Mid, Senior Level
3+ years expKatalyst Healthcares & Life Sciences is focused on the medical device manufacturing sector. They are seeking a CNC Manufacturing Engineer to validate CNC equipment and ensure compliance with GMP/ISO standards in a regulated MedTech environment.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop and execute validation activities for CNC machines (e.g., mills, lathes, multi-axis CNCs) and associated tooling/work holding
Create and maintain validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports
Lead Master Validation Plan, risk assessments (FMEA), and ensure alignment with regulatory requirements (ISO 13485, GMP, 21 CFR Part 820)
Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering to qualify new machines and implement change controls
Design, execute, and document calibration, metrology, and gauge R&R activities; ensure traceability of measurement equipment
Analyze process data (statistical methods, capability studies like Cp/Cpk, Gage R&R) to demonstrate repeatability, accuracy, and process control
Generate, review, and approve validation reports; ensure closure of deviations, CAPAs, and non-conformances
Support supplier qualification and acceptance tests for CNC-related components and tooling
Provide training and knowledge transfer to operators and maintenance staff on validated CNC processes
Ensure compliance with documentation control, record retention, and audit readiness; participate in internal/external audits
Maintain equipment lifecycle documentation (maintenance plans, calibration schedules, firmware/software updates) and ensure alignment with change management processes
Support manufacturing investigations and root-cause analyses related to CNC processes and equipment performance
Qualification
Required
Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline
3–7 years in CNC manufacturing and equipment validation in a regulated environment (MedTech, pharma, or healthcare devices)
Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO 14971) and validation concepts (IQ/OQ/PQ)
Proficiency in developing and executing IQ/OQ/PQ protocols
Experience with metrology, calibration, and measurement system analysis
Knowledge of CNC machines, CAM software, and basic CNC programming concepts
Statistical tools experience (Minitab, JMP, or similar) for process capability studies
Document control and eQMS systems experience (e.g., MasterControl, ETQ, etc.)
Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams
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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