Serves as a technical expert for medical device manufacturing processes, equipment validation, scale-up, supplier capability, risk management, and continuous improvement. Leads pilot and commercial production readiness, process FMEA, validation protocols, technical reviews, change controls, yield analysis, deviation investigations, CAPAs, site transfers, and second-source qualification. Partners with cross-functional teams and suppliers to ensure robust, compliant processes and product quality.
Job Summary
Serves 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 & EEO
The 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.
Nova Pneuma, Inc. is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Equal Opportunity EmployerThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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