GM Production Medical Devices | GMP | ISO Class 5–8 Cleanrooms

We are seeking a technically proficient manufacturing leader with extensive experience in regulated medical device production. The ideal candidate will have a proven track record of ownership from process development and technology transfer through validation, scale-up, and sustained commercial manufacturing. This role requires a strong combination of hands-on manufacturing expertise, deep knowledge of ISO 13485/QMS and GMP standards, regulatory compliance, data-driven process improvement, and leadership skills to build and guide a high-performing production team.

Key Responsibilities

Lead GMP-compliant manufacturing operations for high-risk medical devices, including Class II and Class III devices, within controlled and classified environments such as ISO Class 5–8 cleanrooms. Oversee environmental controls, contamination control, personnel and material flows, gowning, cleaning, and aseptic or controlled manufacturing practices as applicable.

Manage and direct process validation and manufacturing validation activities, including IQ/OQ/PQ, process qualification, cleaning and sterilization validation, packaging validation, equipment qualification, and validation of critical or special processes relevant to the product and manufacturing process.

Lead technology transfer efforts from R&D and prototype stages through process development, pilot production, process validation, and commercial-scale manufacturing. Establish robust manufacturing processes, specifications, work instructions, process controls, and acceptance criteria.

Drive design transfer, design for manufacturability (DFM), process characterization, statistical process control (SPC), capability studies, yield improvement, root-cause analysis, and continuous data-driven process improvements.

Develop and execute capacity planning and production scale-up strategies, including line balancing, equipment qualification, facility readiness, manpower planning, productivity enhancement, and cost optimization.

Establish, monitor, and improve production key performance indicators (KPIs) such as yield, first-pass yield, rejection rates, overall equipment effectiveness (OEE), cycle time, capacity utilization, downtime, and on-time delivery, while maintaining product quality and regulatory compliance.

Apply risk management and risk-based decision-making to manufacturing processes, incorporating ISO 14971 principles to assess process risks, implement controls, and manage changes effectively.

Ensure compliance with applicable medical device manufacturing and product standards by translating regulatory and standards requirements into practical manufacturing controls.

Manage supplier and manufacturer interfaces, including incoming materials, critical components, outsourced processes, and contract manufacturing activities, ensuring proper supplier qualification and quality control.

Build, develop, and lead multidisciplinary production teams comprising senior engineers, supervisors, technicians, and operators, focusing on technical competency, training, accountability, and succession planning.

Provide both strategic and operational leadership, from production strategy and resource planning to troubleshooting complex manufacturing issues and implementing sustainable corrective actions.

Maintain robust technical documentation and manufacturing systems, including SOPs, work instructions, batch/device history records, manufacturing records, process specifications, validation protocols and reports, change controls, deviations, and CAPA documentation.

Drive exceptional problem-solving and decision-making across production operations, turning complex manufacturing, quality, and process challenges into measurable improvements in yield, capacity, compliance, and operational efficiency.

Take full end-to-end ownership of production operations, providing independent leadership, technical direction, and regulatory oversight within a highly regulated medical device manufacturing environment.

Required Qualifications

Master’s degree in Engineering, Manufacturing, Biomedical Engineering, or a closely related discipline, with a strong technical foundation in medical device manufacturing.

Minimum of 10 years of progressive experience in regulated medical device manufacturing, including significant production management and senior operational leadership roles. Experience with Class II/III devices and/or implantable, sterile, drug-device combination, or other high-risk medical devices is highly desirable.

Advanced working knowledge of ISO 13485 and the application of a risk-based Quality Management System throughout manufacturing operations. This includes expertise in process controls, traceability, nonconformance management, CAPA, change control, deviation management, training, document control, and production records.

Strong understanding of medical device regulatory and quality requirements, with experience supporting or leading regulatory inspections, notified-body or third-party audits, customer audits, and internal QMS audits. Proven ability to drive timely and sustainable closure of audit findings.

Demonstrated independent leadership, technical depth, regulatory maturity, and the ability to take full ownership of production operations within a highly regulated medical device environment.

Preferred Qualifications and Benefits

Not explicitly stated in the original description.

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This role offers the opportunity to lead and shape manufacturing operations in a critical and highly regulated sector, combining technical expertise with strategic leadership to ensure product quality, compliance, and operational excellence.