Job Description

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

Position Overview: We are seeking a hands-on Manufacturing Supervisor to lead daily operations for the assembly and production of our laser-based console systems, which are Class II medical devices. The ideal candidate will bring strong leadership, a quality-focused mindset, and working knowledge of laser technology and regulated manufacturing environments (ISO 13485, FDA 21 CFR Part 820). This role is critical in ensuring safety, efficiency, and compliance while delivering high-quality products that meet customer and regulatory standards.

Responsibilities:

• Supervise day-to-day operations of the production floor, including scheduling, assembly, testing, and packaging of laser-based medical console systems.
• Provide technical guidance and support to manufacturing technicians and assemblers.
• Monitor production KPIs (throughput, yield, efficiency, scrap) and drive continuous improvement initiatives.
• Ensure strict compliance with Good Manufacturing Practices (GMP), ISO 13485, and FDA QSR standards.
• Collaborate with Quality, Engineering, and Supply Chain to resolve non-conformances, implement process changes, and support design transfers and validations.
• Maintain production documentation including work orders, device history records (DHRs), and batch records in accordance with regulatory requirements.
• Lead and document root cause investigations, CAPA activities, and deviation reports.
• Train and mentor team members on procedures, safety protocols, and product knowledge.
• Support execution of Engineering Change Orders (ECOs), process validations (IQ/OQ/PQ), and equipment qualification.
• Ensure proper calibration and maintenance of laser systems and production tools.
• Enforce safety, 5S, and lean manufacturing principles.

Qualifications:

Required

• Associate or bachelor’s degree in engineering, Manufacturing, or related technical discipline (or equivalent experience).
• 5+ years of experience in a regulated manufacturing environment, preferably medical devices.
• 2+ years of direct supervisory or team lead experience.
• Familiarity with laser system assembly, optics handling, or electro-mechanical integration.
• Knowledge of ISO 13485, FDA 21 CFR 820, and GMP regulations.
• Excellent problem-solving, communication, and leadership skills.

Preferred

• Experience with laser safety protocols and Class 3B/4 laser systems.
• Prior involvement in design transfer, NPI, or scale-up manufacturing.
• Experience with ERP systems and digital work instructions.
• Lean Six Sigma or other continuous improvement training/certification.

Other Duties/Standards:

Working Conditions

• Fast-paced manufacturing environment requiring standing, walking, and occasional lifting (up to 50 lbs).
• May involve cleanroom or controlled environment protocols.
• Use of PPE and laser safety equipment as required.

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