Job Type
Full-time
Description
- Do you enjoy building and optimizing manufacturing processes that support high-quality medical device production?
- Are you energized by solving engineering challenges while developing innovative manufacturing solutions that improve efficiency and quality?
- Are you looking to join a growing team in the medical manufacturing industry where innovation, collaboration, and continuous improvement directly impact products that save lives?
What would you look forward to in this role?- Developing and optimizing manufacturing processes that ensure efficient, high-quality, and cost-effective production of medical devices.
- Designing tooling, fixtures, and manufacturing workflows that improve production accuracy, repeatability, and operational efficiency.
- Leading engineering activities that support successful new product launches from development through full production readiness.
- Partnering cross-functionally with Quality, Operations, customers, and Engineering teams to solve technical challenges and drive project success.
- Supporting validation activities and regulatory compliance efforts that ensure manufacturing processes meet strict medical industry standards.
- Playing a critical role in manufacturing products that directly support life-saving medical applications.
What key responsibilities would you assume in this role?Device Building & Process Optimization
- Develop and implement manufacturing processes supporting medical device production, including molding, machining, assembly, and post-processing operations.
- Design and implement custom assembly fixtures, inspection tooling, and manufacturing solutions that improve production accuracy and efficiency.
- Optimize production workflows to reduce cycle times, improve product yield, and lower overall manufacturing costs.
- Analyze production data to identify process improvement opportunities and support cost reduction initiatives.
- Troubleshoot manufacturing challenges, identify root causes, and implement corrective actions that improve operational performance.
- Support Lean Manufacturing initiatives focused on improving efficiency, reducing waste, and increasing throughput.
- Evaluate manufacturability of customer device designs to ensure production readiness and efficient manufacturing execution.
- Provide technical feedback during design reviews to improve manufacturability, assembly performance, and product quality.
Project Launch Support
- Lead engineering activities supporting projects from initial development through successful product launch and production readiness.
- Coordinate cross-functional teams including Quality, Operations, customers, and internal stakeholders to align project deliverables and timelines.
- Facilitate technical meetings that drive project alignment, resolve challenges, and maintain momentum toward successful launch milestones.
- Support Sales and business development efforts by assisting with cost estimates, manufacturing quotes, and lead time projections for customer proposals.
- Partner with internal teams to ensure manufacturing readiness before transitioning products into production.
Quality & Validation
- Develop and execute validation protocols supporting equipment, manufacturing processes, and test methods.
- Perform validation activities including Test Method Validation (TMV), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensure manufacturing processes comply with FDA regulations and applicable medical device industry standards.
- Support preparation and maintenance of documentation required for customer regulatory submissions and internal quality systems.
- Collaborate with Quality and Engineering teams to ensure validated manufacturing processes remain scalable, repeatable, and audit-ready.
- Support ongoing compliance initiatives that reinforce PMC's commitment to quality, safety, and regulatory excellence.
Who will you work side by side to achieve extraordinary results?
- Quality, Operations, and Engineering teams focused on successful product development and production execution
- Cross-functional teams supporting new product launches and manufacturing readiness
- Customers and project stakeholders collaborating on medical device development and production requirements
- Internal leadership teams focused on innovation, quality, and operational excellence
- Manufacturing teams committed to producing life-saving products with precision and consistency
Requirements
What is needed to thrive in this role?- Strong manufacturing engineering experience supporting process development, production optimization, and product launch activities.
- Experience developing manufacturing processes involving molding, machining, assembly, and post-processing operations.
- Experience designing tooling, fixtures, and manufacturing systems that improve efficiency and product quality.
- Strong troubleshooting and root cause analysis skills with the ability to solve technical manufacturing challenges quickly and effectively.
- Experience supporting validation activities including IQ, OQ, PQ, and Test Method Validation (TMV).
- Familiarity with FDA regulations, medical device manufacturing requirements, and regulated quality systems.
- Experience supporting new product launches and managing engineering deliverables from development through production.
- Strong project management and cross-functional collaboration skills with the ability to manage multiple priorities simultaneously.
- Experience with Lean Manufacturing, process improvement methodologies, and continuous improvement initiatives.
- Strong communication skills and the ability to work effectively with customers, internal stakeholders, and cross-functional teams.
- A proactive mindset focused on innovation, quality, accountability, and PMC's mission of manufacturing products that save lives.
