Principal NPD Process Engineer

PROMED MOLDED PRODUCTS INC•Plymouth, MN

8h•$115,000 - $152,000•Onsite

About The Position

The Principal New Product Development Process Engineer plays a critical role in transforming innovative product designs into robust, repeatable, and scalable manufacturing processes that enable successful product commercialization. Serving as ProMed's senior technical resource for new product process development, this role leads the design, validation, and optimization of manufacturing processes that consistently deliver quality, efficiency, and regulatory compliance. This role also provides technical leadership and mentorship to other process engineers, operating with minimal supervision while exercising broad independent judgment on complex, high-impact engineering decisions. By partnering with Engineering, Manufacturing, Quality, Tooling, Operations, and customers, the Principal New Product Development Process Engineer helps ensure new products are successfully transferred into production while supporting ProMed's mission of Working As One to Help Many. The Principal New Product Development Process Engineer supports ProMed’s mission and values by applying and reinforcing the company’s brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work.

Requirements

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, Biomedical Engineering, Chemical Engineering, or a related engineering discipline.
Minimum of ten (10) years of progressively responsible engineering experience in process development, manufacturing engineering, new product development, or medical device manufacturing.
Demonstrated success developing and implementing manufacturing processes for new product introductions within regulated manufacturing environments.
Advanced knowledge of silicone molding, injection molding, manufacturing process development, Design of Experiments (DOE), process validation (IQ/OQ/PQ), statistical analysis, and manufacturing process capability.
Strong understanding of FDA regulations, ISO 13485, ISO 14971, risk management principles, validation methodologies, and medical device quality systems.
Experience leading complex engineering initiatives and approving process validation strategies, protocols, and technical documentation.
Strong communication, technical writing, project leadership, customer interaction, and problem-solving skills.
Demonstrated ability to independently manage multiple engineering priorities while effectively collaborating across cross-functional teams.
Demonstrated experience providing technical leadership, mentorship, or informal guidance to other engineers, with the ability to operate effectively with minimal supervision.

Nice To Haves

Master's degree in Engineering or related technical discipline.
Lean Six Sigma Green Belt, Black Belt, or Design for Six Sigma (DFSS) certification.
Experience with automation systems, advanced manufacturing technologies, equipment qualification, and process optimization.
Experience supporting customer-facing engineering activities within a medical device contract manufacturing organization.
Experience with statistical software, Minitab, SolidWorks, or similar engineering analysis and design applications.

Responsibilities

Lead the development of robust manufacturing processes that successfully transition new medical device products from concept through manufacturing readiness while supporting customer expectations, business objectives, and regulatory requirements.
Design, develop, evaluate, and optimize manufacturing processes that improve product quality, repeatability, manufacturability, scalability, and operational efficiency throughout the product lifecycle.
Serve as ProMed's senior technical resource for new product process development by applying advanced engineering principles, sound technical judgment, and manufacturing expertise to solve complex process challenges.
Provide technical leadership and mentorship to other process engineers, guiding their development and elevating engineering standards and practices across the team, while operating with minimal supervision.
Lead process development activities including process characterization, equipment selection, tooling recommendations, Design of Experiments (DOE), process optimization, and manufacturing readiness planning.
Evaluate manufacturing risks throughout the product development lifecycle and implement engineering solutions that improve process capability, reduce variability, and support successful product launches.
Develop, review, and approve process validation strategies, protocols, and documentation, including IQ, OQ, and PQ activities, ensuring compliance with customer requirements, quality systems, and applicable regulatory standards.
Partner with New Product Development Project Engineers to ensure products are designed for manufacturability, scalability, quality, and long-term production success.
Collaborate with Manufacturing, Quality, Tooling, Operations, Supply Chain, Sales, and customers to develop manufacturing solutions that support efficient product commercialization and operational excellence.
Support customer technical discussions by providing engineering expertise related to manufacturing processes, process capability, validation strategies, and production readiness.
Evaluate new manufacturing technologies, equipment, materials, automation opportunities, and engineering methodologies that strengthen ProMed's manufacturing capabilities and competitive advantage.
Develop engineering documentation including process flow diagrams, work instructions, validation reports, technical studies, process specifications, and engineering recommendations that support successful product transfer into production.
Support development builds, pilot manufacturing activities, engineering trials, and production readiness efforts to ensure successful implementation of new manufacturing processes.
Identify opportunities to improve process development methodologies, validation practices, engineering standards, and technical documentation that strengthen organizational capability and support continuous improvement.
Provide technical guidance and subject matter expertise to cross-functional project teams while fostering collaboration, knowledge sharing, and sound engineering decision-making.
Support ProMed's mission and values by ensuring the company's brand, philosophy, systems, policies, and procedures are consistently applied and upheld.