Manufacturing Engineer

Katalyst Healthcares and Life Sciences

Raynham, MA

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:

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.
nalyze 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).

Education & Experience:

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.

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Vacancy posted 4 days ago

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