Job SummaryServes as the technical expert for internal and external manufacturing processes, ensuring they are robust, validated, and ready to support product launch and scale-up. This role reviews concepts and supports the development and build-up of manufacturing equipment. The engineer partners with cross-functional teams and suppliers to manage risk, maintain product quality, and drive continuous process improvement.
Responsibilities- Technical SME and support for internal and external manufacturing processes ensuring alignment with product requirements
- Ensure readiness for pilot builds, commercial scale-up and capacity expansion
- Drive timelines aligned to product launch milestones
- Own deliverables during scale-up
- Define and ensure validation strategy for equipment (IQ/OQ/PQ) and support process performance validation
- Support or lead internal process or equipment validation efforts
- Assess internal and external technical capability
- Evaluation impact of 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 data
- Review deviation investigations and CAPAs impacting product quality
- 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
- Strong cross-functional leadership, communication, project management, and ability to work under tight deadlines
- Excellent oral and written communication skills as well as strong interpersonal skills
- Well versed in medical device regulatory requirements from Food and Drug Administration (FDA), European
- Medicines Agency (EMA), etc. and regulatory standards
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+ years of experience in design/development/troubleshooting of medical devices and/or electromechanical systems
- Hands-on experience with process and equipment validation (IQ/OQ/PQ/PPQ), including authoring and approving protocols and reports
- Experience managing suppliers through pilot builds and commercial scale-up, including supplier capability assessments and on-site audits
- Experience with risk management and problem-solving tools, including PFMEA, root cause analysis and CAPA
- Experience working in compliance with GMP and GDP regulations
- Experience in numerical modeling including CFD
- Experience in statistical analysis, including use of tools such as JMP for data analysis and experimental design
- Experience designing and troubleshooting electronic and mechanical systems
- Experience with CAD software (SolidWorks) including preparation of engineering drawings using GD&T preferred
- Experience in designing injection molded parts preferred
- Experience programming in LabVIEW a plus
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
Compensation & EEOThe base salary for this role ranges between $164,000-209,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes a discretionary bonus program, diverse health and other benefits.
