Job Summary
Bridges the gap between R&D and mass production, optimizing manufacturing processes, supplier quality, and cost-efficiency. They lead product ramp-ups, conduct Design for Manufacturing (DFM) analyses, audit suppliers, and ensure high-quality, high-yield production.
Responsibilities
- Technical SME and support for external suppliers ensuring alignment with product requirements
- Ensure supplier readiness for pilot builds, commercial scale-up and capacity expansion
- Drive timelines aligned to product launch milestones
- Own supplier-side deliverables during scale-up
- Define and ensure validation strategy at suppliers for equipment (IQ/OQ/PQ) and support process performance validation
- Support or lead internal process or equipment validation efforts
- Draft, review and approve protocols and reports
- Assess supplier technical capability
- Evaluation impact of supplier change requests, process improvements and raw material substitution
- Perform on-site technical reviews and gap assessments
- Lead process FMEA and risk mitigation with supplier teams
- Ensure traceability from design inputs to production controls
- Draft, review and approve protocols and reports
- Analyze yield, scrap and defect
- Review deviation investigations and CAPAs impacting product
- Identify process optimization opportunities
- Evaluate second-source suppliers for risk mitigation and assist with site transfers and line expansion
- Author technical justification for change controls and supplier RFC as required
Skills required
- Excellent mechanical aptitude and good attention to details
- Experience designing and troubleshooting electronic and mechanical systems
- Experience with CAD software (SolidWorks) including preparation of engineering drawings using GD&T preferred
- Experience in numerical modeling including CFD
- Experience in statistical analysis, including use of tools such as JMP for data analysis and experimental design
- Experience in designing injection molded parts preferred
- Excellent oral and written communication skills as well as strong interpersonal skills
- Experience programming in LabVIEW a plus
- Well versed in medical device regulatory requirements from Food and Drug Administration (FDA), European
- Medicines Agency (EMA), etc. and regulatory standards
- Experience working in compliance with GMP and GDP regulations
Education and experience
- Bachelor’s degree in Mechanical, Electrical, Industrial or Mechatronics Engineering or equivalent
- Master’s or higher-level degree in Engineering, Physics or related field, or demonstrated equivalent experience.
- 10-15 years of experience in design/development/troubleshooting of medical devices and/or electromechanical systems
- Strong cross-functional leadership, communication, project management, and ability to work under tight deadlines
Physical Requirements
- Prolonged periods of sitting at a desk and working on a computer
- Potentially prolonged periods standing
- Must be able to lift up to 15 pounds at times
- Must be willing to travel
