Manufacturing Engineer

POSITION SUMMARY:
The Manufacturing Engineer will be responsible for working with contract manufacturers to develop, validate, and sustain manufacturing processes for Class III neurostimulation products, including implantable pulse generators (IPGs), leads, and external systems. This role focuses on process development, design transfer, component and supplier management, and continuous improvement within an FDA QSR and ISO 13485–regulated environment. The engineer will work cross-functionally with R&D, Quality, Regulatory, and contract manufacturers to ensure safe, effective, and cost-efficient manufacturing.

RESPONSIBILITIES:
Manufacturing Engineering & Process Development:

• Become the subject matter expert on manufacturing processes for neurostimulation products (IPGs, leads, accessories) from pilot to production.
• Work with R&D, regulatory, and suppliers to develop and improve manufacturing processes.
• Collaborate on process validations (IQ/OQ/PQ) for critical manufacturing and test processes (e.g., laser welding, adhesive bonding, helium leak testing, impedance/resistance testing, battery welding) in compliance with FDA 21 CFR 820 and ISO 13485.
• Implement Design for Manufacturability (DFM/DFA) principles and lead manufacturability reviews with R&D to reduce complexity, cycle time, and cost.
• Establish and maintain control plans, inspection methods, and SPC for key product and process characteristics (e.g., impedance, output current, hermeticity, battery performance).
• Drive continuous improvement activities to ensure ongoing improvement and cost effectiveness.

Component & Supplier Management:

• Serve as the primary manufacturing engineering interface for critical component suppliers (leads, PCBs, batteries, etc.).
• Define and maintain technical specifications, drawings, and incoming inspection requirements for supplied components.
• Support supplier qualification activities including process reviews, capability assessments, and risk evaluations.
• Lead technical investigations and dispositions of incoming nonconformances; initiate and support Supplier Corrective Action Requests (SCARs) and drive closure of corrective actions.
• Participate in supplier audits and remote assessments, providing process and technical input and ensuring alignment with ISO 13485 and FDA requirements.
• Support dual-sourcing efforts and component change management (PCNs, risk assessments, validation impact analysis) to ensure robust and resilient supply.

Documentation & Compliance:

• Create and maintain manufacturing documentation, including work instructions, routers, BOMs, setup sheets, process FMEAs, validation protocols and reports, and change orders (ECOs).
• Ensure all manufacturing processes and documentation comply with FDA QSR, ISO 13485, and internal quality system procedures.
• Support internal and external audits (FDA, ISO, customer) by providing data, documentation, and technical explanations; assist in developing and implementing responses and corrective actions.

REQUIRED and PREFERRED QUALIFICATIONS:

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing, Electrical Engineering, or related discipline.
• Required 5+ years of experience in manufacturing engineering for medical devices, with preference for Class III implantable or neurostimulation products.
• Ability to travel up to 15%.
• Demonstrated experience in component and supplier management (specifications, incoming inspection, SCARs, supplier qualification/support).
• Experience with process validation (IQ/OQ/PQ) in an FDA-regulated, ISO 13485 environment.
• Familiarity with cleanroom manufacturing (ISO Class 7/8) and GMP practices.
• Experience with structured root cause analysis and CAPA (8D, 5-Why, Fishbone).
• Strong skills in technical documentation, including work instructions, validation documentation, and risk management tools (FMEA, pFMEA, DFMEA).
• Demonstrated ability to work cross-functionally with R&D, Quality, Regulatory, and Supply Chain.
• Experience specifically with neurostimulation systems (spinal cord stimulation, deep brain stimulation, peripheral nerve stimulation) and associated components (leads, IPGs, external controllers) preferred.
• Working knowledge of Design Control (21 CFR 820.30) and ISO 14971 risk management preferred.
• Lean Six Sigma Green Belt or higher.
• Experience with PLM/ERP systems (Agile, Arena, Windchill, SAP, Business Central, Oracle) and 3D CAD tools (SolidWorks, Creo, or similar).