Manufacturing Engineer - Sustaining

About the position

SetPoint Medical’s Manufacturing Engineer - Sustaining will be responsible for maintaining and improving the manufacturing processes of SetPoint's novel medical device. The ideal candidate will have a robust understanding of medical device systems engineering and medical device manufacturing. This role requires gathering relevant data, conducting independent research, formulating hypotheses, executing experiments, and drafting reports for submission to quality and regulatory bodies. As a member of the Operations team, the Manufacturing Engineer - Sustaining will play a key role in implementing continuous improvement initiatives and resolving manufacturing issues to ensure consistent product quality and manufacturing efficiency. This position reports to the Engineering Manager. This position is in office, Monday - Friday, reporting to company headquarters in Valencia, CA.

Responsibilities

• Collaborate with Product Development, Operations, Quality, and Contract Manufacturers to support sustained manufacturing operations in accordance with regulatory and QMS compliance
• Analyze existing manufacturing processes and implement improvements to enhance yield, quality, and efficiency
• Lead failure investigations using industry tools such as 8D, FMEA, and root cause analysis, ensuring thorough cross-functional review and closure
• Plan, perform, and document qualification and validation activities (TMVs, IQs, OQs, and PQs) for existing manufacturing processes and equipment
• Troubleshoot manufacturing issues by analyzing process data, conducting investigations, and implementing corrective actions
• Support sustaining engineering activities including ECOs, deviations, and change requests to maintain regulatory compliance
• Create and update manufacturing documentation including work instructions, assembly procedures, and test protocols
• Train production operators on new or revised manufacturing processes and procedures
• Monitor key performance indicators (KPIs) and implement process improvements to optimize manufacturing operations
• Support QMS compliance by participating in acceptance activities, CAPAs, NCRs, QRB, and related quality initiatives
• Maintain technical specifications, drawings, and production control documentation
• Identify and implement cost reduction opportunities without compromising product quality
• Assist with other activities as required

Requirements

• B.S. degree in Biomedical, Electrical, Mechanical Engineering, or a related STEM field (advanced degree preferred)
• 2+ years of medical device manufacturing experience
• Class III medical device manufacturing knowledge and experience
• Knowledge of failure investigation techniques and tools
• Experience with process verifications and validations, and statistics
• Strong understanding of hardware specifications, manufacturing methods and procedures
• Experience with ISO 13485, GMP guidelines, and FDA regulations
• Proficiency with using lab equipment (DMMs, oscilloscopes, function generators, etc.) to gather measurements
• Skilled in mechanical systems and basic electromechanical assemblies
• Proficiency with reading and creating manufacturing drawings and procedures
• Proficiency in CAD solid modeling, CAD/CAM circuit design, and Microsoft Office Suite
• Strong analytical and critical thinking skills, with attention to detail
• Excellent writing skills