Principal Project Engineer

PROMED MOLDED PRODUCTS INC; Plymouth (MN); On-site; USD 144,000 - 199,000; Full time

Benefits offered by this job

401k with company match

Profit sharing

Medical Insurance

Health Savings Account / Flexible Sp.

Vision Insurance

Life Insurance

Paid Family Medical Leave and LTD

Hospital Indemnity

Critical Illness

Accident Insurance

Identity Theft Protection

Pet Insurance

Job summary

ProMed is seeking a Principal New Product Development Project Engineer to own projects from strategy to delivery in a medical device environment. You will translate customer needs into production plans within ProMed's regulated manufacturing setting, balancing cost, schedule, and quality while guiding teams and mentoring engineers.

The role emphasizes driving commercialization of innovations with rigorous design, development, and regulatory compliance to meet FDA and ISO standards, while

Qualifications

• Working knowledge of English, both verbal and written.
• Previous experience interfacing with customers and managing project communications – timelines, costs, and risks.
• Bachelor of Science in engineering or physical science; Master’s with relevant experience as an alternative.

Responsibilities

• Lead complex product development initiatives from strategy through delivery.
• Develop and validate engineering designs, tooling concepts, and process specifications.
• Lead project planning including timeline development, resource allocation, and risk assessment.
• Prepare detailed project timelines, cost estimates, and resource requirements.
• Apply engineering analysis and project coordination tools to maintain technical accuracy and cost control.
• Solve complex engineering problems and optimize product designs to reduce development cycles and improve quality.
• Cultivate strategic customer relationships through expert technical consultation and communication.

Skills

English proficiency

Project management

Customer communication

Engineering design methodologies

Regulatory knowledge

Education

BS in engineering or physical science

MS in related field with experience

Job description

Salary Range: $144,125.92 To $198,893.77 Annually

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.

Your work matters here! ProMed is looking for a Principal New Product Development Project Engineer to serve as the project owner — fully accountable for the project from strategy through delivery. You'll understand the customer's needs and translate their requirements into a realistic plan within ProMed's manufacturing environment, all while balancing cost, timeline, quality, and risk with authority and clarity. You'll lead customer communication directly, negotiate contracts, guide technical teams, and mentor other engineers and project managers along the way.

WHY THIS ROLE MATTERS

The mission of this role is to drive successful commercialization of medical device innovations through expert engineering design, development, and technical execution that meet stringent regulatory requirements and quality standards. This position ensures organizational competitiveness by optimizing engineering designs, processes, and technical capabilities to reduce cycle times while maintaining compliance with FDA and ISO quality systems. The role strengthens market position by building strategic customer relationships through technical consultation that translates clinical needs into viable product solutions. Additionally, this position enhances organizational capability by developing engineering talent and establishing consistent technical practices that support sustainable growth and operational excellence across the product development lifecycle.

WHAT YOU’LL ACHIEVE

While the ways that you fulfill these responsibilities will likely evolve, your core responsibilities are:

Drive technical engineering design and development to deliver complex product development initiatives that meet design intent, on time and within budget, resulting in successful commercialization of medical device innovations and enhanced organizational capability

On average this should be about 30% of your time. Among other things this means we expect you to:

• Conduct regular project reviews with stakeholders to ensure alignment and address emerging challenges
• Develop and validate engineering designs, tooling concepts, and process specifications that meet customer requirements and manufacturability standards
• Lead comprehensive project planning activities including timeline development, resource allocation, and risk assessment
• Prepare detailed project timelines, cost estimates, and resource requirements based on technical specifications
• Apply engineering analysis and project coordination tools to maintain technical accuracy, schedule adherence, and cost control

Apply deep technical expertise to solve complex engineering problems and optimize product and process designs, resulting in reduced development cycle times and enhanced product quality

On average this should be about 25% of your time. Among other things this means we expect you to:

• Innovate and implement process improvements for moderately complex technical processes
• Perform engineering analysis of mold, tooling, and process designs to identify technical risks and improvement opportunities
• Ensure all documentation meets internal and external quality system requirements
• Predict complex technical interactions and develop contingency plans to mitigate project risks
• Apply design for manufacturing practices to translate customer requirements into feasible production solutions

Cultivate strategic customer relationships through expert technical consultation and communication, resulting in increased customer satisfaction and expanded business opportunities

On average this should be about 20% of your time. Among other things this means we expect you to:

• Interface with customers via phone, email, and in-person meetings to understand requirements and expectations
• Translate complex technical information into accessible summaries for diverse audiences
• Lead customer interactions regarding project updates including cost, timeline, and quality considerations
• Collaborate with customers to recommend appropriate studies and development project plans
• Communicate project timelines, costs, and risks clearly to customers and internal stakeholders

Build technical expertise and organizational knowledge across engineering teams through mentorship and guidance, resulting in improved team capabilities and consistent engineering practices

On average this should be about 15% of your time. Among other things this means we expect you to:

• Identify and implement comprehensive education plans to advance technical skills and organizational effectiveness
• Make recommendations to management concerning improvements to processes and procedures
• Train and provide work direction to technicians, engineers, and manufacturing operators as required
• Provide guidance to others on tool design, project management, and quality systems deliverables
• Share technical knowledge with engineers and project managers regarding innovation and design development

Ensure regulatory compliance and quality system adherence across all engineering activities, resulting in successful audits and maintained certifications

On average this should be about 10% of your time. Among other things this means we expect you to:

• Establish and cultivate networks across laboratory, quality, manufacturing, engineering, sales, and marketing functions
• Execute functional deliverables associated with customer orders, project management, and quality systems
• Apply complex customer requirements in project management of process development activities
• Ensure proper documentation including technical reports, project plans, and validation documentation

Necessary Skills:

• Engineering Design and Development (Expert)
• Medical Device Development (Expert)
• ISO 13485 Quality Systems (Expert)
• Cross-Functional Team Leadership (Expert)
• Technical Communication (Expert)
• Risk Assessment and Mitigation (Expert)
• Customer Relationship Management (Expert)
• Process Development and Validation (Proficient)
• Design for Manufacturing (DFM) (Expert)
• Molding Theory and Mold Design (Expert)
• Design Verification and Validation (Proficient)
• Technical Documentation (Proficient)
• Problem-Solving and Critical Thinking (Proficient)
• Mentoring and Training (Proficient)
• Cost Estimation and Budgeting (Proficient)
• Regulatory Compliance (Proficient)

MINIMUM REQUIREMENTS

Minimum Qualifications For The Role:

• Working knowledge of English, both verbal and written
• Previous experience with medical device development or highly regulated manufacturing environments
• A Bachelor of Science degree in engineering or physical science from an accredited university, or a Master's degree with at least 2 years of applicable experience in a related field
• The ability to work independently with minimal supervision while managing multiple priorities and deadlines
• At least 10 years of applicable engineering experience, or at least 2 years with a Master's degree
• Previous experience interfacing with customers and managing project communications regarding timelines, costs, and risks
• A demonstrable working knowledge of engineering design methodologies, project coordination tools, and best practices

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, and grasp as needed for facility navigation and equipment interaction
• Visual acuity for close vision to read handwritten or typed material and the ability to adjust focus for detailed technical work
• Ability to move about the building and maneuver in tight spaces between desks and equipment
• Physical capability to walk on even or uneven surfaces during facility tours and site visits
• Manual dexterity for grasping and manipulating pens, markers, scissors, staplers, and other office equipment
• Ability to use whiteboards requiring grasping pens, reaching at various heights, and trunk or neck rotation
• Physical stamina to push or pull equipment such as computers, overhead projectors, and presentation materials weighing up to 25 pounds
• Ability to see and hear on a continuous basis and speak frequently for meetings, presentations, and customer interactions
• Physical flexibility to vary between standing, sitting, and walking throughout the workday with occasional need to move quickly over smooth or uneven surfaces

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.