Medical Device Manufacturing Engineer

Responsibilities: Lead investigations and manage dispositions for all manufacturing nonconformances. Review, optimize, and validate manufacturing processes for quality and regulatory compliance. Own tooling and equipment qualification and calibration. Manage supplier quality, including evaluations, audits, and SCARs. Drive internal CAPAs tied to manufacturing issues. Track production data, identify trends, and drive continuous improvement efforts. Train and support the team on QMS processes, GMP, and process controls. Maintain and improve manufacturing documentation, inspection procedures, and Device History Records.

Required Qualifications: Bachelor’s degree in Manufacturing, Mechanical, Biomedical, or Industrial Engineering; or 8+ years of relevant experience. 3+ years in a regulated environment (medical devices preferred). Clear, concise technical writing skills. Working knowledge of QMS elements such as CAPA, Training, Nonconformance, and Change Control. Familiarity with ISO 13485. Comfortable supporting internal and external audits. Skills That Will Make You SuccessfulPractical experience in manufacturing and quality engineering. Detail-oriented mindset with a focus on mistake-proofing. Solid engineering fundamentals: materials, manufacturing, test methods, and root cause analysis. Clear communicator with both technical and nontechnical stakeholders. Collaborative team player and proactive problem solver. The company provides a comprehensive benefits package, includingmedical insurance , dental reimbursement ,15 days of paid time off(PTO) plus federal holidays, and a401(k) planwith both pre-tax and Roth options.