Position Description:

As a member of the SetPoint Medical Operations team, the Manufacturing Engineer will be responsible for overseeing 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. As specific tasks arise, the right individual will need to gather relevant data, undertake independent research, formulate hypotheses, conduct experiments as needed, and draft reports for submission to quality and regulatory bodies. 

The Manufacturing Engineer will play a meaningful role in the development and implementation of continuous improvement efforts within the organization.

Position Responsibilities:

• Interface with Product Development, Operations, Quality, and Contract Manufacturers to ensure technology transfer and manufacture of new products is performed in accordance with regulatory and QMS compliance
• Create test plans and reports facilitating documentation of functional, electrical, and mechanical drawing and specifications
• Utilizing industry tools, perform failure investigation activities, ensuring complete cross-functional review and close out
• Plan, perform, report qualification and validation activities (TMVs, IQs, OQs, and PQs)
• Evaluate manufacturing processes by designing and conducting research activities; apply knowledge of product specification, design, fabrication, assembly, tooling, materials; and confer with contract manufacturers by soliciting observations from operators
• Develop manufacturing processes by studying product requirements, researching, designing, modifying, and testing manufacturing methods and equipment
• Work with production to identify and implement process improvements
• Support QMS compliance by performing acceptance activities, CAPAs, NCRs, QRB, process improvements, and operator training
• Create and manage documentation of functional, electrical, and mechanical specifications, drawings, and production control
• Assist with other activities as required

Minimum Qualifications:

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

Travel Requirements: Up to 30% 

Location: Company Headquarters in Valencia, CA 

Company Description: 

SetPoint Medical is a development stage medical device company pioneering the development of bioelectronics therapy for the treatment of chronic inflammatory diseases.