Principal NPD Process Engineer

ProMed Molded Products, Inc.; Plymouth (MN); On-site; USD 115,000 - 152,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account / Flexible SpE

Vision Insurance

Life Insurance

Paid Family Medical Leave

Long-Term Disability Insurance

Hospital Indemnity

Critical Illness

Pet Insurance

Job summary

ProMed Molded Products, Inc. seeks a Principal New Product Development Process Engineer to transform innovative designs into scalable manufacturing workflows.

You will lead process development, validation, and transfer of medical devices, collaborating across Engineering, Manufacturing, Quality, Tooling, and Customer teams to ensure regulatory compliance and production readiness. You will mentor engineers, apply advanced engineering principles, and shape processes that improve quality,

Qualifications

• Bachelor's degree in Mechanical Engineering or related discipline is required.
• Minimum 10 years of progressive engineering experience in process development/manufacturing/medical devices.
• Experience developing and implementing manufacturing processes for new product introductions in regulated environments.
• Strong knowledge of silicone molding, injection molding, tooling design, and automation.
• Familiarity with FDA regulations, ISO 13485, ISO 14971, risk management, and validation methodologies.
• Ability to independently manage multiple priorities and lead cross-functional teams.
• Proven track record of mentorship and guiding engineers to higher standards.
• Excellent communication, technical writing, and problem-solving skills.

Responsibilities

• Lead development of manufacturing processes from concept to manufacturing readiness.
• Design, evaluate, and optimize processes for quality, repeatability, and scalability.
• Act as senior technical resource for new product process development and DOE.
• Provide mentorship and raise engineering standards across the team.
• Oversee process validation strategies, protocols, and documentation (IQ/OQ/PQ).
• Collaborate with Manufacturing, Quality, Tooling, Operations, and Customer teams.
• Identify opportunities to adopt new technologies and improve methodologies.
• Ensure documentation supports successful transfers into production.

Skills

Manufacturing process development

DOE

Statistical analysis

Process validation

Regulatory compliance

FDA regulations

Mentorship

Cross-functional collaboration

Analytical thinking

Documentation practices

Education

Bachelor's degree in Mechanical or related engineering

Tools

SolidWorks

Job description

Salary Range: $115,000.00 To $152,000.00 Annually

Team: New Product Development

History:

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

WHY THIS ROLE MATTERS

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.

WHAT YOU’LL ACHIEVE

• 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.

Necessary Skills:

• Demonstrates advanced expertise in manufacturing process development, Design of Experiments (DOE), process validation, statistical analysis, process capability, and engineering problem solving within regulated manufacturing environments.
• Applies extensive knowledge of silicone molding, injection molding, tooling design, automation, manufacturing equipment, materials, and engineering principles to develop reliable, repeatable, and scalable manufacturing processes.
• Demonstrates strong knowledge of FDA regulations, ISO 13485, ISO 14971, risk management principles, process validation methodologies, and medical device quality systems.
• Builds collaborative relationships across Engineering, Manufacturing, Quality, Tooling, Operations, Sales, Supply Chain, and customer organizations to successfully commercialize new products.
• Communicates complex technical concepts clearly and effectively while supporting cross-functional decision making, customer confidence, and successful project execution.
• Exercises sound engineering judgment by balancing product requirements, manufacturing capability, quality expectations, regulatory compliance, project timelines, and business objectives, operating independently with minimal supervision.
• Demonstrates exceptional analytical thinking by evaluating technical risks, identifying process improvement opportunities, and implementing innovative manufacturing solutions.
• Maintains exceptional documentation practices that support engineering decisions, process validation, regulatory compliance, knowledge sharing, and organizational consistency.
• Demonstrates curiosity and continuous learning by evaluating emerging manufacturing technologies, engineering methodologies, automation solutions, and industry best practices that strengthen ProMed's technical capabilities.
• Builds organizational capability by establishing engineering standards, promoting process consistency, mentoring other engineers, and serving as a trusted technical resource for new product process development.

Requirements

Minimum Qualifications for the Role

Required

• 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.

Preferred

• 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.

Physical, Sensory, Cognitive & Neurological Demands:

• Requires the ability to safely perform the physical movements necessary to carry out the essential functions of the role, including sitting, standing, walking, bending, reaching, lifting, pushing, pulling, and repetitive movements throughout the workday.
• Requires mobility throughout office, laboratory, manufacturing, and customer environments to support engineering evaluations, manufacturing process development, equipment qualification, validation activities, and cross-functional collaboration.
• Requires the ability to effectively communicate highly technical information through verbal, written, and presentation formats with customers, suppliers, leadership, and cross-functional teams.
• Requires advanced analytical, mathematical, and critical thinking abilities to evaluate manufacturing processes, analyze engineering data, assess process capability, solve complex technical challenges, and make sound engineering decisions.
• Requires visual, auditory, and cognitive abilities sufficient to review engineering drawings, technical specifications, process documentation, validation reports, manufacturing data, and quality records.
• Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.

HOW YOUR SUCCESS WILL BE MEASURED

Success in this role is measured by your ability to develop manufacturing processes that enable successful commercialization of innovative medical device products, while supporting quality, efficiency, scalability, and regulatory compliance. You solve complex manufacturing challenges, develop robust validation strategies, and collaborate across departments to ensure products transfer successfully into production. Through technical leadership, mentorship, and continuous improvement, you strengthen ProMed's manufacturing capabilities and long-term success.

Your Key Performance Indicators:

• Successful commercialization and transfer of new products into manufacturing.
• Manufacturing process capability, repeatability, and robustness.
• Process validation quality, timeliness, and regulatory compliance.
• Product launch readiness and successful production transfer.
• Engineering project support and milestone achievement.
• Manufacturing process improvements and efficiency gains.
• Technical documentation accuracy and completeness.
• Customer satisfaction with engineering support and technical solutions.
• Continuous improvement and implementation of innovative manufacturing technologies.
• Compliance with ProMed engineering, quality, and regulatory standards.
• Effectiveness of technical mentorship and leadership provided to other engineers.

Competency

Description

Process Engineering Excellence

Develops innovative, scalable manufacturing processes that consistently deliver quality, efficiency, and production readiness.

Technical Leadership

Provides engineering expertise, mentorship, and technical guidance that supports informed decision-making and organizational success, operating with minimal supervision.

Strategic Problem Solving

Evaluates complex manufacturing challenges and develops practical, sustainable engineering solutions.

Manufacturing Partnership

Collabora effectively with Manufacturing, Quality, Tooling, Operations, and Project Engineering to ensure successful commercialization.

Customer Focus

Understands customer requirements and develops manufacturing solutions that support product quality, regulatory compliance, and long-term customer success.

Identifies and implements new technologies, engineering methodologies, and process improvements that strengthen ProMed's competitive advantage.

Accountability

Takes ownership of engineering decisions, validation strategies, and process outcomes while consistently delivering high-quality results.

Champions engineering excellence by strengthening process development methodologies, validation practices, and organizational technical capabilities.

ProMed offers a generous benefits package including:

• 401k with company match
• Profit Sharing Program
• Medical Insurance
• Health Savings Account/Flexible Spending Account
• Vision Insurance
• Life Insurance
• Paid Family Medical Leave and Long-Term Disability Insurance
• Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection
• Pet Insurance

ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.