Manufacturing Engineer

Job Description:

• Education: Bachelor's degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.
• Experience: 5+ years in manufacturing and equipment validation in a regulated environment (MedTech, pharma, or healthcare devices).
• Regulatory & Standards: Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO 14971) and validation concepts (IQ/OQ/PQ).
• Technical Skills:
• Proficiency in developing and executing IQ/OQ/PQ protocols.
• Experience with metrology, calibration, gauge R&R 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.
• Lead Master Validation Plan, risk assessments (FMEA), CAPA
• Document control and eQMS systems experience (e.g., MasterControl, ETQ, etc.).

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.