Product Development Engineer

Job Title: Product Development Engineer Location: St. Paul, MN Contract: 12+ Months

Experience: 4 - 8 Years

Overview

We are seeking a Product Development Engineer to support the design and development of complex capital equipment and devices. This role requires hands-on experience in Solidworks modeling, injection molding, and mechanical testing. The engineer will work closely with cross-functional teams to conceptualize, design, analyze, and validate mechanical components and systems. The position also involves supporting design reviews, compliance with regulatory standards, and contributing to continuous improvement initiatives. An ideal candidate is an E2-level Mechanical Engineer who is detail-oriented, technically strong, and able to collaborate across teams to deliver innovative and reliable solutions.

Key Responsibilities

Perform system design of capital equipment devices, select components and processes, and propose design alternatives.

Design hardware to support product features and develop hardware design specifications.

Assist product definition teams with feature selection.

Ensure compliance with FDA regulations, regulatory requirements, company policies, and operating procedures.

Complete component and system designs using Solidworks, including requirements, BOM creation, and documentation.

Plan, coordinate, and execute activities of development teams in support of project goals.

Communicate project successes, risks, and roadblocks effectively to management.

Perform product analysis using empirical and computational models to mitigate risks.

Conceptualize new designs using innovative approaches.

Interface with internal teams, external consultants, vendors, and medical professionals.

Support animal studies, bench testing, clinical evaluations, and production activities.

Lead and contribute to design reviews and continuous improvement initiatives.

Solve technical problems using sound judgment, data analysis, and creativity.

Establish product requirements and specifications, including supplier collaboration and validation.

Required Qualifications

Bachelor’s degree in Mechanical Engineering or related field.

4+ years of relevant hardware design, development, and testing experience.

Proficiency in 3D CAD, particularly Solidworks.

Experience with metals (machining, forming) and plastics (molding, machining, forming).

Strong communication skills across multiple organizational levels.

Familiarity with manufacturing processes for reliable devices.

Preferred Qualifications

• Familiarity with IEC 60601 standards.

• Knowledge of electronics and medical device development.

• Proven ability to develop new designs and design features.

• Strong analytical skills, including statistical tools.

• Experience with manual fabrication equipment (mills, lathes, etc.).

• Background in medical device manufacturing processes and methods.

• Ability to thrive in a matrixed, cross-division, and fast-paced environment.

• Strong organizational skills, multitasking, and attention to detail.