Overview

We are partnering with a growing medical device design and manufacturing organization to hire a Product Development Engineer specializing in minimally invasive medical devices and catheter-based technologies.

The company serves as a contract design, development, and manufacturing partner to medical device OEMs, helping customers take new technologies from early-stage concepts through feasibility, design, prototyping, verification/validation, design transfer, and manufacturing.

This creates a very different engineering environment than many large medical device OEMs.

Rather than owning one narrow portion of a mature product, engineers work across the development lifecycle, solve problems directly at the bench, rapidly build and evaluate prototypes, develop manufacturing processes, and collaborate directly with customer engineering teams.

We're looking for an engineer who enjoys that hands-on, fast-moving development environment and has meaningful experience actually designing, building, and developing medical devices—not simply testing finished designs.

The Opportunity

As a Product Development Engineer, you'll serve as a key technical contributor across complex catheter development programs.

Projects can involve technologies such as extruded tubing, braided and coiled reinforced shafts, balloons, steerable or deflectable systems, catheter assemblies, fixtures, tooling, and associated manufacturing processes.

You'll help translate customer and clinical requirements into engineering solutions, evaluate feasibility, build and test prototypes, refine designs, develop manufacturing processes, and ultimately help transfer successful products into production.

Depending on experience, you'll also lead technical workstreams, interact directly with customers, mentor developing engineers, and take significant ownership over design decisions and project execution.

What You'll Be Doing

Catheter Design & Product Development

  • Develop complex medical device components, assemblies, and catheter systems
  • Translate customer and product requirements into practical engineering solutions
  • Support concept development, feasibility evaluations, prototyping, and design iteration
  • Work with catheter technologies including extrusions, reinforced shafts, balloons, assemblies, and steerable/deflectable systems
  • Evaluate characteristics such as pushability, torqueability, flexibility, trackability, and system performance
  • Perform tolerance analysis, technical trade studies, and design optimization
  • Use SolidWorks and sound mechanical design principles to develop production-ready solutions

Hands-On Prototyping & Process Development

  • Build and evaluate prototypes throughout the development lifecycle
  • Develop processes for manufacturing complex catheter components and assemblies
  • Design fixtures, tooling, and test equipment
  • Rapidly iterate designs based on testing, manufacturing feedback, and customer requirements
  • Troubleshoot technical and process challenges at the bench
  • Collaborate closely with manufacturing as designs mature toward production
  • Support process-development and validation activities during design transfer

Verification, Validation & Risk Management

  • Develop and execute verification and validation strategies
  • Architect test methods and develop appropriate fixtures and protocols
  • Analyze test results and produce clear technical reports
  • Conduct engineering risk assessments and support formal risk-management activities
  • Apply statistical methods to engineering and process-development challenges
  • Utilize Minitab for DOE, regression, capability analysis, and other statistical evaluations
  • Maintain accurate and compliant documentation throughout the development process

Technical Leadership & Customer Collaboration

  • Serve as a technical contributor in cross-functional reviews with Quality, Regulatory, Manufacturing, suppliers, and other engineering resources
  • Present engineering findings and recommendations directly to customers
  • Participate in technical planning discussions with customer engineering teams
  • Drive technical decisions and resolve design challenges with limited oversight
  • Lead portions of development programs or technical workstreams based on experience
  • Mentor junior and mid-level engineers and help reinforce engineering best practices

What We're Looking For

The strongest candidate is a hands-on medical device engineer who knows how products are actually built.

Direct catheter development experience is especially attractive. We're interested in engineers who understand the physical construction and development of catheter systems—not simply individuals who have worked somewhere within the catheter or medical-device industry.

Experience within a medical device contract manufacturer, CDMO, design consultancy, or similarly fast-paced development environment is particularly valuable because you'll be accustomed to balancing multiple customer programs, changing requirements, rapid iteration, and the pace of contract product development.

We're also more interested in what you've actually owned and built than simply your number of years in the industry. An engineer with fewer years of experience but substantial hands-on design, prototyping, and process-development responsibility may be more compelling than someone with significantly longer tenure focused primarily on testing or a narrow portion of the development lifecycle.

Qualifications

Required

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline
  • 2+ years of medical device product-development experience
  • Meaningful ownership of engineering design and development deliverables
  • Hands-on experience developing prototypes, processes, test methods, fixtures, or tooling
  • Strong understanding of medical device design controls and regulated product development
  • Knowledge of QMSR, ISO 13485:2016, and ISO 14971
  • Strong SolidWorks capabilities
  • Experience with GD&T, tolerance stack-ups, and design optimization
  • Experience developing and executing engineering test methods
  • Ability to analyze engineering data and make technically sound decisions
  • Ability to drive design challenges toward resolution with limited oversight
  • Strong communication skills and ability to work effectively across engineering, quality, regulatory, and manufacturing teams

Highly Preferred

  • Direct experience developing catheter-based or minimally invasive medical devices
  • Experience with catheter extrusion, reinforced shafts, braiding/coiling, balloon forming, catheter assembly, or steerable devices
  • Medical device contract manufacturing / CDMO experience
  • Strong process-development experience
  • Experience taking products from concept and feasibility through design transfer and manufacturing
  • Experience working directly with medical device OEM customers
  • Minitab experience, including DOE, regression, and capability analysis
  • Experience leading technical workstreams or mentoring other engineers

Compensation & Benefits

Base Salary: $120,000–$160,000, depending on experience and technical depth

The organization also offers a comprehensive benefits package, including:

  • Medical, dental, and vision coverage
  • Multiple medical plan options, including HSA-eligible plans
  • Employer HSA contribution of $500 for individual coverage / $1,000 for family coverage
  • 401(k) with a 50% employer match on employee contributions up to 6%
  • Flexible Time Off
  • 9 paid holidays
  • Voluntary short- and long-term disability coverage
  • Voluntary life insurance
  • Critical illness coverage
  • Hospital indemnity coverage
  • Accident coverage

Why This Opportunity

  • Build, don't just analyze: Work directly with prototypes, processes, fixtures, tooling, testing, and manufacturing
  • Own more of the lifecycle: Participate from early concepts and feasibility through commercialization and design transfer
  • Complex catheter technology: Develop sophisticated minimally invasive devices involving extrusions, reinforced shafts, balloons, and steerable systems
  • Fast development cycles: Work in an environment built around iteration, problem-solving, and getting new technologies to market
  • Direct customer exposure: Collaborate with engineering teams developing next-generation medical technologies
  • Technical variety: Solve different engineering challenges across multiple development programs rather than spending years on one mature product
  • Real technical ownership: Your responsibilities are driven by your capabilities—not simply your tenure
  • Leadership runway: Experienced engineers can lead workstreams, mentor teammates, and take increasing ownership over customer programs
  • Strong Twin Cities medtech opportunity: Join a specialized product-development organization in the heart of the Maple Grove medical-device community

Location & Work Environment

This position is based onsite in Maple Grove, Minnesota.

Given the hands-on nature of the work, engineers spend significant time collaborating with other engineers and manufacturing resources, developing prototypes, conducting testing, troubleshooting processes, and supporting customer programs.

This is best suited for someone who enjoys being close to the product and the manufacturing process rather than working primarily from a desk or within a narrowly defined engineering specialty.

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