Manufacturing Engineer - Medical Device - Hudson, WI

This Senior Manufacturing Engineer position offers the opportunity to lead new product introductions, process development, and manufacturing scale-up initiatives for complex medical device programs in a highly regulated environment. The role combines technical leadership, process validation, continuous improvement, and cross-functional project management to ensure successful product transfers and operational excellence.

Client Details

Our client is a rapidly growing advanced manufacturing organisation supporting some of the world's leading medical technology companies. Specializing in precision engineering, product development, prototyping, and high-volume manufacturing, the company helps bring innovative medical devices from concept through production. With significant investment in technology, automation, and operational excellence, they have established themselves as a trusted partner within the medical device industry.

Their collaborative culture encourages innovation, continuous improvement, and professional development while providing employees with exposure to cutting-edge manufacturing techniques and highly impactful healthcare products. As the business continues to expand globally, they offer a fast-paced environment where talented engineers can make meaningful contributions while advancing their careers.

Description

We are seeking a Senior Manufacturing Engineer to lead manufacturing readiness, process development, validation, and production support activities for medical device programs. This individual will serve as a key contributor to new product introductions, ensuring manufacturing processes are robust, scalable, compliant, and capable of meeting customer expectations. Working across engineering, quality, operations, and customer teams, the successful candidate will drive technical problem solving, continuous improvement initiatives, and process optimisation efforts throughout the product lifecycle.

• Lead new product introduction (NPI) and product transfer activities from development into manufacturing.
• Design, develop, and optimise manufacturing processes, tooling, fixtures, and production methods.
• Drive validation activities including IQ/OQ/PQ, equipment qualification, and process documentation.
• Analyse manufacturing performance, troubleshoot technical issues, and implement corrective actions.
• Collaborate with customers, quality teams, and operations to support programme execution and growth.

Profile

The ideal candidate is an experienced manufacturing engineer with a strong background supporting regulated production environments and bringing complex products into manufacturing. They possess excellent analytical and project management abilities, a structured approach to problem solving, and the communication skills required to work effectively with both customers and cross-functional teams. Experience within medical devices or similarly regulated industries will be highly advantageous.

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Minimum of 6 years' manufacturing engineering experience, preferably within a regulated environment.
• Strong knowledge of NPI, process validation, GMP principles, and quality management systems.
• Proficiency with statistical analysis, DOE, process capability studies, and continuous improvement methodologies.
• Experience with SolidWorks, tooling design, GD&T, and technical documentation development.

Job Offer

This opportunity provides exposure to cutting-edge medical technologies while working within a growing organisation known for technical excellence and innovation. Employees enjoy a collaborative environment where engineering expertise is valued, career progression is encouraged, and individuals can directly influence manufacturing performance and product success. The role offers diverse technical challenges, high visibility projects, and the opportunity to contribute to products that positively impact patient outcomes worldwide.

• Competitive salary package.
• Opportunity to work on advanced medical device technologies and manufacturing processes.
• Strong career development prospects within a rapidly expanding global organisation.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.