Description
Senior Process Development Engineer
Position Overview
We are seeking an experienced Senior Process Development Engineer to provide technical leadership in the design, development, validation, and optimization of manufacturing processes, tooling, and equipment for innovative single-use medical devices.
This role will have a strong focus on design transfer and process validation, partnering cross-functionally with R&D, Quality, Regulatory, and Operations to move new products from early-stage development into manufacturing. The Senior Process Development Engineer will lead IQ/OQ/PQ activities, provide Design for Manufacturability (DFM) expertise, develop manufacturing documentation, and ensure processes are robust, scalable, compliant, and ready for production.
This is an opportunity to join a growth-stage medical device organization and take a hands-on role in new product introduction, manufacturing engineering, and continuous improvement.
Key Responsibilities
- Lead design transfer activities from R&D through manufacturing, ensuring products and processes are ready for successful production.
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in accordance with FDA QMSR and ISO 13485 requirements.
- Partner with product development teams early in the design cycle to provide Design for Manufacturability (DFM) input and reduce downstream manufacturing risk.
- Optimize manufacturing processes through Design of Experiments (DOE), process capability studies, and engineering analysis.
- Establish standard work, manufacturing methods, and equipment operating parameters.
- Author, review, and maintain documentation supporting design transfer, process validation, SOPs, work instructions, and Medical Device File requirements.
- Develop and implement manufacturing automation solutions.
- Design, prototype, and evaluate manufacturing fixtures and tooling as needed.
- Troubleshoot manufacturing equipment and process issues and implement effective corrective actions.
- Analyze quality and manufacturing problems and identify opportunities for process improvement.
- Ensure appropriate engineering studies, design verification, and process validation activities are completed before processes are transferred into manufacturing.
- Maintain traceability between process validation results and applicable design inputs.
- Partner with Quality Control and suppliers to resolve supplier quality issues.
- Define and track design transfer readiness criteria, milestones, and deliverables.
- Coordinate cross-functionally with R&D, Quality, Regulatory, and Operations throughout the design transfer process.
- Support manufacturing and engineering objectives related to product performance, quality, cost, process validation, and safety.
- Provide technical guidance to technicians and junior engineers and may supervise daily activities.
- Ensure compliance with applicable Good Manufacturing Practices (GMPs), Standard Operating Procedures, and company quality requirements.
Qualifications
- Bachelor’s degree in Manufacturing, Mechanical, Industrial, Plastics Engineering, or a related engineering discipline.
- 7+ years of experience in an equipment-intensive medical device manufacturing environment.
- Direct experience developing and executing IQ/OQ/PQ process validation protocols is required.
- Strong understanding of ISO 13485, FDA QMSR, design transfer, and medical device manufacturing requirements.
- Demonstrated experience working cross-functionally with Quality, Operations, R&D, and other technical teams.
- Strong process development, troubleshooting, and continuous improvement skills.
- Ability to manage multiple priorities and projects in a fast-paced, dynamic environment.
- Strong organizational, written, and verbal communication skills.
- Hands-on engineering approach with demonstrated technical leadership capabilities.
Preferred Qualifications
- 1–2 years of direct supervisory or team leadership experience.
- Project management experience.
- Experience with SolidWorks, including the design, prototyping, and evaluation of fixtures and tooling.
- Experience with plastics manufacturing processes such as extrusion, injection molding, or fiber forming.
- Experience developing or implementing manufacturing automation solutions.
What You’ll Bring
You are a hands-on process development engineer who understands what it takes to move a medical device from design into a validated, production-ready manufacturing process. You can work across engineering, quality, regulatory, and operations teams while maintaining the technical rigor and documentation required in a regulated medical device environment.