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Process Development Engineer
About the Role
We are seeking a hands-on Process Development Engineer to support the transition of innovative medical device designs into robust, scalable, and compliant manufacturing processes. This role partners closely with R&D, Operations, Quality, and external manufacturing partners to ensure products are developed with manufacturability, reliability, and regulatory requirements in mind.
This is a high-visibility, high-ownership position offering exposure across multiple customer programs and technologies. It is well-suited for engineers who thrive in fast-paced environments, enjoy working across the full product lifecycle, and are motivated by technical growth and real-world impact.
Key Responsibilities
Process & Manufacturing Development
- Lead and support process development and characterization once prototype designs are available
- Develop scalable manufacturing processes with strong design-for-manufacturability (DFM) principles
- Evaluate materials, tooling, and equipment to optimize process performance and reliability
- Support catheter-based manufacturing processes including molding, bonding, extrusion, and assembly
Risk Management & Validation
- Lead or contribute to Process FMEAs (PFMEA) and related risk management activities
- Develop and execute process validation plans (IQ, OQ, PQ)
- Define process specifications, acceptance criteria, and control strategies
- Partner with Quality to ensure alignment with design controls and regulatory standards
Manufacturing Readiness & Transfer
- Prepare development programs for transfer to internal manufacturing or external partners
- Support equipment qualification, line setup, and cleanroom manufacturing environments
- Develop process documentation, work instructions, and manufacturing test methods
- Serve as a technical bridge between R&D and Operations during scale-up and production readiness
Project Ownership & Collaboration
- Own technical deliverables for assigned development programs
- Support multiple projects across different stages of the product lifecycle
- Collaborate cross-functionally with Engineering, Quality, Operations, and suppliers
- Communicate progress, risks, and recommendations clearly to stakeholders
Qualifications
- Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related Engineering discipline
- Experience in medical device development or manufacturing environments
- Hands-on background in process development, characterization, or manufacturing scale-up
- Working knowledge of process validation and regulated product development
- Experience in cleanroom manufacturing environments
- Strong analytical and problem-solving skills
- Ability to manage multiple priorities independently
- Demonstrated ownership mindset and proactive approach
Preferred Experience
- Catheter-based device development and manufacturing
- PFMEA, process validation, and manufacturing transfer
- SolidWorks for drawing and tolerance review
- Extrusion, molding, bonding, and precision assembly processes
- Experience in a CDMO or multi-customer environment
- Supporting products from prototype through commercialization
What Success Looks Like
- Prototype designs are translated into robust, repeatable, and scalable manufacturing processes
- You take ownership of meaningful portions of development programs
- You partner effectively with both R&D and Operations
- You grow rapidly through exposure to multiple technologies, customers, and development stages
Why This Opportunity
- Broad exposure across multiple medical device programs and technologies
- Accelerated technical and career growth compared to traditional single-product environments
- Strong mentorship from senior engineers
- Hands-on, high-impact engineering culture
- Opportunity to directly influence products that improve patient outcomes
Benefits
- Comprehensive Medical, Dental, and Vision coverage
- Retirement plan with company match
- Generous PTO, personal days, and paid holidays
- Wellness programs and lifestyle benefits
- Life Insurance, AD&D, and Disability coverage
- Paid parental and family leave
