Principal Project Engineer

PROMED MOLDED PRODUCTS INC•Plymouth, MN

8d•$144,126 - $198,894•Onsite

About The Position

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. 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.

Requirements

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
Project Management Methodologies (Proficient)
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)
Microsoft Project (Proficient)
Microsoft Office Suite (Proficient)
Design Verification and Validation (Proficient)
Technical Documentation (Proficient)
Problem-Solving and Critical Thinking (Proficient)
Mentoring and Training (Proficient)
Cost Estimation and Budgeting (Proficient)
Supplier Management (Proficient)
Regulatory Compliance (Proficient)

Responsibilities

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
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
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
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
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
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