Medical Device Manufacturing Engineer

Overview

We are seeking a hands-on quality assurance engineer with strong manufacturing, root-cause analysis, and quality systems experience. This hybrid Quality/Manufacturing role owns key elements of the Quality Management System (QMS), including Nonconformance Management, Equipment Qualification/Calibration, Incoming and In-Process Inspection, and Supplier Quality, while contributing to improving product quality, cost, and manufacturability.

• 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.

• 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.

• Practical 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, including medical insurance
, dental reimbursement
, 15 days of paid time off (PTO) plus federal holidays, and a 401(k) plan with both pre-tax and Roth options.