Development Engineer - Medical Device

Nuwellis, Inc. • Eden Prairie, MN

1d • $105,000 - $125,000

About The Position

Nuwellis is seeking a Development Engineer who enjoys solving complex technical problems, takes ownership of their work, and wants to see their designs make a real difference for patients. As a Development Engineer, you will play a key role in designing, developing, testing, and improving innovative medical technology. You will work alongside Engineering, Quality, Regulatory, Clinical, Marketing, and Operations, contributing throughout the product lifecycle from early design concepts through verification, validation, design transfer, and ongoing product improvements. Due to the smaller organization size, you will have the opportunity to be involved in more than just one piece of the process, working closely with experienced colleagues across multiple disciplines, gaining visibility into decision-making, and seeing the direct impact of your work on products and patients.

Requirements

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related engineering discipline.
• 3–6 years of experience developing medical devices.
• Experience working within FDA Design Controls and ISO 13485.
• Experience developing electro-mechanical products.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• The ability to manage multiple priorities while working collaboratively across cross-functional teams.

Nice To Haves

• Experience with ISO 14971 risk management.
• Experience planning or executing verification and validation testing.
• Experience supporting design transfer into manufacturing.
• Experience working with contract manufacturers or suppliers.
• Familiarity with medical device standards such as IEC 60601, IEC 62366, ISO 10993, or similar.

Responsibilities

• Design, prototype, and evaluate electro-mechanical medical devices and disposable products.
• Contribute throughout the product development lifecycle, from concept through commercialization and ongoing product improvements.
• Develop engineering documentation, specifications, test protocols, reports, and Design History File documentation.
• Plan and execute product verification and validation testing.
• Participate in design reviews, risk assessments, and engineering change activities.
• Support development efforts involving usability, biocompatibility, packaging, sterilization, shelf life, labeling, and test method validation.
• Analyze engineering and test data to identify opportunities for product improvements and resolve technical challenges.
• Partner with Quality, Regulatory, Clinical, Marketing, Operations, and external suppliers to move projects forward.
• Support design transfer activities and product qualification while ensuring compliance with FDA Design Controls and applicable international standards.
• Assist with root cause investigations and implementation of corrective actions.
• Contribute to continuous improvement initiatives across products and engineering processes.

Benefits

• Salary: $105,000–$125,000 depending on experience and qualifications.
• Eligible for annual discretionary bonus.
• Medical insurance with multiple plan options, including a High Deductible Health Plan (HDHP) with an annual company HSA contribution of $2,000 for individual coverage or $4,000 for family coverage.
• Company contributions toward dental and vision insurance.
• Employer-paid life insurance (up to one times annual salary), plus short-term and long-term disability coverage.
• Generous Paid Time Off (PTO), floating holidays, and 8 paid company holidays.
• 401(k) plan with a 3% company match.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level