Working knowledge of

ISO 13485

Quality Management System Experience manufacturing Class II or Class III medical devices About Our Client Our client is a global provider of advanced engineering, prototyping, product development, and precision manufacturing solutions serving the medical device industry. The organization partners with leading healthcare companies to bring innovative technologies from concept through commercialization, with expertise in complex manufacturing processes and highly regulated environments. Job Description Lead new and existing medical device programs from process development through production. Manage development and build schedules while serving as a technical liaison with customers and internal stakeholders. Collaborate with engineering, operations, quality, and manufacturing teams to support product launches and ongoing production needs. Design and develop manufacturing processes, tooling, and fixtures that optimize product quality, operational efficiency, capacity, and workplace safety. Provide production support through process improvements, troubleshooting, equipment optimization, operator training, and issue resolution. Create, update, and maintain manufacturing documentation in accordance with established quality system requirements. Drive continuous improvement efforts through structured problem-solving methodologies and data-driven decision making. Analyze manufacturing performance and recommend process or equipment enhancements. Prepare technical reports and communicate project results to both internal leadership and external customers. Lead process validation activities and associated documentation, including

IQ/OQ/PQ

protocols, manufacturing process validations, equipment commissioning, and preventive maintenance programs. 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. The Successful Applicant Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline, or equivalent industry experience. 6+ years of manufacturing engineering experience, preferably within a regulated industry. Strong experience with New Product Introduction (NPI), Product Development Processes (PDP), and manufacturing scale-up activities. Demonstrated ability to solve complex technical problems using disciplined engineering and analytical methodologies. Proficiency in statistical analysis tools and techniques, including process capability studies, regression analysis, ANOVA, DOE, and equivalency studies. Experience using SolidWorks or similar CAD software for tooling and fixture design. Strong understanding of GD&T and technical drawing generation. Experience with structured problem-solving methodologies such as Six Sigma, DMAIC, A3, and 5 Why analysis. Excellent technical writing skills with the ability to develop manufacturing procedures, validation protocols, and engineering reports. Strong project management, planning, and organizational skills. Ability to work effectively in cross-functional environments and manage multiple priorities. Strong communication skills with experience presenting project updates to customers, leadership teams, and key stakeholders. Preferred Qualifications Experience manufacturing Class II or Class III medical devices. Advanced degree in an Engineering or Scientific discipline. Experience with interventional medical devices, including design, assembly, packaging, and sterilization. Experience serving as a cross-functional technical lead on medical device development programs. Lean Six Sigma certification or formal training. Working knowledge of

ISO 13485

Quality Management Systems. PMP certification or formal project management training. What's on

Offer Salary:

$100,000 - $125,000 Comprehensive health and insurance benefits Paid Vacation time 401k with company match available