Manufacturing Engineer III

As a Manufacturing Engineer III, you will serve as the technical anchor bridging Product Development and Operations. In this hands-on role, you will lead the transition of innovative medical devices from R&D through design transfer, driving Design for Manufacturability (DFM), pilot line validation, and robust process development. Partnering closely with Quality Assurance and Regulatory teams, you will establish scalable manufacturing processes and documentation systems that uphold our uncompromising quality standards.

Duties & Responsibilities

• Serve as the primary manufacturing technical lead on New Product Introduction (NPI) core teams, partnering early with R&D to drive Design for Manufacturability (DFM), Design for Assembly (DFA), and seamless design transfer into commercial production.
• Architect, establish, and optimize robust manufacturing processes and standardized Control Plans, ensuring critical-to-quality (CTQ) parameters are controlled, and processes meet target capability prior to commercialization.
• Lead the conceptualization, CAD design, and qualification of custom jigs, fixtures, and tooling across assembly cells, sterilization, QA inspection, and final packaging to maximize yield and operator ergonomics.
• Author, execute, and approve complex equipment and process validation protocols (IQ/OQ/PQ, Test Method Validation) in strict compliance with ISO 13485 regulatory requirements.
• Plan and execute complex engineering studies, Design of Experiments (DOE), and root cause analyses (RCA) to characterize process windows, resolve technical bottlenecks, and drive data-backed decisions.
• Author and govern manufacturing documentation systems, including pFMEAs, Work Instructions (WIs), and operator training frameworks, to ensure repeatable execution and audit readiness.
• Lead complex technical investigations for nonconformances, customer complaints, and CAPA initiatives, implementing systemic corrective actions that eliminate recurring failure modes.
• Partner directly with key customers, suppliers, and external equipment vendors to align on technical specifications, manufacturability milestones, and deliverable timelines.

Education and Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Biomedical, or Materials Science Engineering (or related technical discipline).
• Master’s degree in Engineering preferred.
• Minimum of 5–8 years of progressive engineering experience in medical device manufacturing, New Product Introduction (NPI), or complex regulated production environments.
• Deep working knowledge of FDA Quality System Regulation (21 CFR Part 820 / QMSR), ISO 13485, with direct experience supporting regulatory audits and cleanroom operations.
• Proven track record leading end-to-end equipment and process validations (IQ/OQ/PQ, Test Method Validation) and executing formal design transfer milestones from R&D to commercial manufacturing.
• Hands-on expertise authoring and maintaining pFMEAs, standardized Control Plans, and statistical process control (SPC) frameworks to achieve target process capability.
• Proficient in 3D CAD modeling (e.g., SolidWorks) for fixture/tooling design and statistical analysis software (e.g., Minitab, JMP) for Design of Experiments (DOE) and root cause analysis.

Benefits

Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 11 company paid holidays.