Medical Device Manufacturing Engineer at PMC Smart Solutions LLC

Shelbyville, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Sep, 26

Salary

0.0

Posted On

18 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Manufacturing Process Development, Tooling and Fixture Design, IQ/OQ/PQ Validation, Test Method Validation, Lean Manufacturing, Root Cause Analysis, FDA Regulatory Compliance, Project Management, Cross-functional Collaboration, Medical Device Manufacturing, Process Optimization, New Product Launch, ISO 13485, Clean Room Operations, Cost Reduction, Design for Manufacturability

Industry

Medical Equipment Manufacturing

Description

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? If yes, PMC SMART Solutions is the place for you! Who is PMC SMART Solutions? PMC, as a globally-recognized, award-winning contract manufacturer, provides life-saving medical devices and safety-enhancing automotive components to a broad base of international, market-leading OEMs and Tier One customers. PMC offers services from design for manufacturability and program management through injection molding, full assembly, packaging and sterilization management, focusing on precise-tolerance, intricate devices and components. For its medical customers, PMC functions under ISO 13485 certification, FDA registration and operates state-of-the-art, certified Class 8 (100,000) clean rooms. PMC is a certified Women-Owned Business Enterprise, offering a comprehensive range of services while supporting global OEMs’ supplier diversity goals. 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.

Responsibilities

Develop and optimize manufacturing processes for medical devices, including the design of custom tooling and fixtures to improve efficiency. Lead engineering activities for new product launches while ensuring strict adherence to FDA regulations and quality validation protocols.