Manufacturing EngineerKatalyst Healthcares & Life Sciences • Raynham, MA, United States
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Manufacturing Engineer
Katalyst Healthcares & Life Sciences • Raynham, MA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Perform process validation planning, execution, and reporting according to regulatory and internal requirements. Create and maintain validation documentation, including IQ, OQ, and PQ protocols and reports . Develop manufacturing documentation such as work instructions and standard operating procedures (SOPs) . Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering for machine qualification and change controls. Conduct calibration, metrology, and Gauge R&R studies ensuring full traceability of measurement equipment. Analyze process data using statistical tools (e.g., Minitab, JMP) to evaluate Cp / Cpk, repeatability, and process control. Review and approve validation reports and ensure timely closure of deviations, CAPAs, and non-conformances . Support design and development activities by applying GD&T principles and understanding medical device manufacturing processes. Maintain compliance with ISO 13485, GMP, 21 CFR Part 820 , and risk management (ISO 14971). Bachelor's degree in Mechanical engineering , Manufacturing Engineering , Biomedical Engineering , or a related discipline. 2 5 years of experience in medical device manufacturing or regulated environments (MedTech, pharma, healthcare devices). Hands-on experience with process validation (IQ / OQ / PQ) and manufacturing process documentation. Strong technical writing experience for validation documents and SOPs. Experience in metrology, calibration , and measurement system analysis (Gauge R&R) . Knowledge of CNC machines, CAM software , and basic CNC programming. Proficiency with statistical software such as Minitab or JMP . Experience with document control and eQMS systems (MasterControl, ETQ, etc.). Strong communication skills with the ability to present findings to cross-functional teams.
Job Summary :
- The Manufacturing Validation Engineer will support medical device manufacturing operations by planning, executing, and documenting process, equipment, and measurement system validations.
- This role ensures compliance with ISO 13485, GMP, and 21 CFR Part 820 requirements while partnering with cross-functional teams to qualify equipment, improve processes, and maintain a validated state.
- The engineer will be responsible for creating validation protocols (IQ / OQ / PQ), performing statistical analysis, supporting calibration / metrology activities, and resolving validation-related quality issues.
Roles & Responsibilities :
Education & Experience :
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