Medical Device Manufacturing Engineer

PMC Smart Solutions LLC•Shelbyville, IN

14h

About The Position

PMC SMART Solutions is seeking a Medical Device Manufacturing Engineer to join their growing team. This role involves developing and optimizing manufacturing processes for high-quality medical device production, solving engineering challenges, and developing innovative manufacturing solutions to improve efficiency and quality. The company is a globally-recognized, award-winning contract manufacturer providing life-saving medical devices and safety-enhancing automotive components. PMC operates under ISO 13485 certification, FDA registration, and state-of-the-art clean rooms, focusing on precise-tolerance, intricate devices and components.

Requirements

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.

Responsibilities

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.
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.
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.