Development Engineer - Medical Device

Description

Nuwellis is not accepting resumes from 3rd party recruiters.

Development Engineer

Overview

If you're the kind of engineer who enjoys solving complex technical problems, likes taking ownership of your work, and wants to see your designs make a real difference for patients, we'd love to meet you.

As a Development Engineer, you'll play a key role in designing, developing, testing, and improving our innovative medical technology. Working alongside Engineering, Quality, Regulatory, Clinical, Marketing, and Operations, you'll contribute throughout the product lifecycle—from early design concepts through verification, validation, design transfer, and ongoing product improvements.

Because we're a smaller organization, you'll have the opportunity to be involved in far more than just one piece of the process. You'll work closely with experienced colleagues across multiple disciplines, have visibility into how decisions are made, and see the direct impact your work has on both our products and the patients who depend on them.

What You'll Do

• 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.

Requirements

What You'll Bring

• 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.

It Would Be Great If You Also Have

• 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.

Why Join Nuwellis?

At Nuwellis, you'll be part of a collaborative team where your ideas matter and your contributions are visible. Rather than being responsible for one small piece of a large organization, you'll have the opportunity to work across multiple phases of product development, collaborate directly with decision-makers, and help shape products that improve patient care.

What We Offer

We believe great people deserve great benefits. Here's a snapshot of what we offer:

• 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.

A Few Things You Should Know About Us

• You'll work closely with leaders across Medical Affairs, Clinical, Regulatory, Quality, Marketing, and Commercial.
• Your work will be visible and will have a meaningful impact on the organization.
• We value people who take initiative, ask thoughtful questions, and enjoy solving problems.
• We believe the best ideas can come from anyone, regardless of title.
• We appreciate people who are collaborative, dependable, adaptable, and willing to jump in wherever they're needed.

Any offer of employment is contingent upon the successful completion of a background check and drug screening.

Nuwellis participates in E-Verify. For more information, please visit http://www.uscis.gov/e-verify.