Principal Process Engineer, Injection Molding - NMPH - Rice Creek/Fridley, MN (Onsite)

This position is based at the Rice Creek facility in Fridley, Minnesota and requires a minimum of four days onsite each week in a laboratory and engineering development environment. The role includes collaboration with internal product development teams, manufacturing sites, contract manufacturers, tooling suppliers, and external development partners. <25% travel may be required to support manufacturing partners and technology transfer activities.

As Principal Process Engineer, Advanced Manufacturing Engineering (AME), you will provide technical leadership for manufacturing feasibility, rapid prototyping, and process development efforts supporting emerging implantable device technologies. This role focuses on developing and maturing manufacturing processes for complex implantable assemblies, identifying process risks, and establishing scalable manufacturing approaches that support future commercialization. The position serves as a key manufacturing partner to research and development teams while influencing manufacturing strategy, technical standards, and organizational capability development.

Primary Responsibilities

• Lead manufacturing feasibility assessments and process development activities for novel implantable medical device concepts and emerging therapies.
• Develop and evaluate proof-of-concept manufacturing methods for implantable assemblies, stimulation leads, and miniature electromechanical components.
• Drive rapid prototyping and iterative experimentation to assess manufacturability, process capability, failure mechanisms, and design tradeoffs.
• Provide technical leadership in micro-insert molding, over-molding, precision injection molding, mold tool design, implantable lead assembly, and precision assembly technologies.
• Partner with research and development teams to apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles during product development.
• Establish process characterization strategies, design of experiments (DOE), process windows, and manufacturing readiness assessments to support process maturation.
• Collaborate with manufacturing sites, contract manufacturers, tooling vendors, and automation suppliers to transition prototype processes into scalable production solutions.
• Mentor engineers and influence technical decision-making across cross-functional teams to strengthen manufacturing capability and engineering rigor.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related engineering discipline and a minimum of 7 years of experience in manufacturing engineering, OR Master's degree in manufacturing engineering, process development, or medical device manufacturing and a minimum of 5 years of relevant experience, OR PhD with minimum of 3 years of relevant experience
• Demonstrated expertise in micro-insert molding and over-molding, including mold tool design, process development, and molding process optimization.
• Experience developing, characterizing, and troubleshooting manufacturing processes for precision-engineered products or assemblies.
• Experience designing and executing process characterization studies and Design of Experiments (DOE) to establish process capability and operating windows.

Preferred Qualifications

• Experience with implantable lead manufacturing, conductor assembly, or other implantable medical device manufacturing processes.
• Experience with precision assembly automation, fixture design, and advanced manufacturing technologies.
• Experience supporting early feasibility manufacturing, rapid prototyping, and iterative product development environments.
• Experience transferring manufacturing processes from development or pilot environments into commercial-scale production.
• Experience working with contract manufacturers, tooling suppliers, and external development partners to develop scalable manufacturing solutions.