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Remote Medical Device Design Jobs in Minnesota (NOW HIRING)

Heraeus

Regulatory Affairs Specialist

Minneapolis, MN · On-site +1

$110K - $120K/yr

... Medical Device Design Engineer * Alternatively, Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Pharmacy, Biology, or Chemistry 2 years of experience as a ...

Varsity Tutors

Biomedical Engineering Tutor

Edina, MN · Remote

$18 - $40/hr

Ability to explain signal processing for biosignals, finite element analysis, drug delivery systems, and medical device design principles while preparing students for biomedical engineering ...

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Remote Medical Device Design information

What is remote medical device design?

Remote medical device design refers to the process of developing and engineering medical devices while working from a location outside of a traditional office or laboratory, often using digital collaboration tools. Professionals in this field may design, prototype, test, and iterate devices such as diagnostic tools, monitoring equipment, or implants, all while collaborating with teams virtually. This approach allows for greater flexibility, access to global talent, and the ability to quickly adapt to changes in project requirements or regulatory standards. Remote medical device designers need strong communication skills, technical expertise, and familiarity with relevant regulations and standards.

What is the difference between Remote Medical Device Design vs Remote Medical Device Manufacturing?

AspectRemote Medical Device DesignRemote Medical Device Manufacturing
Primary FocusConcept development, product design, prototypingProduction, assembly, quality control
Required SkillsCAD, biomedical engineering, regulatory knowledgeManufacturing processes, quality assurance, equipment operation
Work EnvironmentDesign studios, labs, remote collaborationFactories, production lines, remote monitoring
CertificationsBiomedical engineering, FDA regulationsISO standards, manufacturing certifications

Remote Medical Device Design focuses on creating and developing new medical devices, while Remote Medical Device Manufacturing involves producing and assembling these devices. Both roles require specialized knowledge and often collaborate closely, but they differ in their core activities and skill sets.

What are some common challenges encountered when designing medical devices remotely, and how can they be addressed?

One of the main challenges in remote medical device design is effective collaboration, especially when teams are distributed across different time zones and may have limited access to physical prototypes. To address this, teams often rely on advanced digital collaboration tools, virtual whiteboards, and cloud-based CAD platforms to share designs and feedback in real time. Regular virtual meetings and clear documentation protocols are essential for maintaining alignment and ensuring regulatory compliance. Additionally, early and frequent communication with manufacturing and regulatory specialists helps to anticipate and resolve potential issues before they become major obstacles.

What are the key skills and qualifications needed to thrive as a Remote Medical Device Designer, and why are they important?

To thrive as a Remote Medical Device Designer, you need expertise in biomedical engineering, product development, and regulatory standards, often supported by a relevant engineering degree. Familiarity with CAD software, prototyping tools, and knowledge of FDA or ISO regulations is typically required. Excellent problem-solving, communication, and project management skills help in collaborating virtually with cross-functional teams. These skills ensure innovative, compliant device designs that meet clinical needs and succeed in competitive markets.
What are the most commonly searched types of Medical Device Design jobs in Minnesota? The most popular types of Medical Device Design jobs in Minnesota are:
What are popular job titles related to Remote Medical Device Design jobs in Minnesota? For Remote Medical Device Design jobs in Minnesota, the most frequently searched job titles are:
What job categories do people searching Remote Medical Device Design jobs in Minnesota look for? The top searched job categories for Remote Medical Device Design jobs in Minnesota are:
What cities in Minnesota are hiring for Remote Medical Device Design jobs? Cities in Minnesota with the most Remote Medical Device Design job openings:
Remote Medical Device Design jobs near you
Infographic showing various Remote Medical Device Design job openings in Minnesota as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% Remote job distribution.
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Heraeus

Minneapolis, MN • On-site, Remote

$110K - $120K/yr

Other

Medical, Dental, Vision, Retirement, PTO

Posted 11 days ago

Heraeus Group rating

6.9

Company rating: 6.9 out of 10

Based on 11 frontline employees who took The Breakroom Quiz

Job description

Regulatory Affairs Specialist
Fridley 
 

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.


About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

Position Summary

The Regulatory Affairs Specialists are responsible for initiating global regulatory strategies for new products and post-market changes. They review post-market changes for devices currently marketed to determine regulatory impact and prepare and/or review US FDA 510(k) regulatory submissions and 510(k) letters to file to obtain/maintain U.S. market clearance.

We are hiring two positions and these are based at the Fridley, MN location and Telecommuting permitted 4 days per week.

What You'll Do Every Day:

  • Initiate global regulatory strategies for new products and post-market changes.
  • Review post-market changes for devices currently marketed to determine regulatory impact.
  • Prepare and/or review US FDA 510(k) regulatory submissions and 510(k) letters to file to obtain/maintain U.S. market clearance.
  • Prepare and/or review technical documentation for Health Canada and submit regulatory recertifications and change notifications as appropriate.
  • Prepare and/or review appropriate documentation for initial submissions, change notifications, or renewals for EU MDR CE marked devices.
  • Keep up to date with changing regulations and educate cross functional peers on new medical device regulations, such as EU MDR or relevant guidance published by the FDA, etc.
  • Review international submissions to be submitted by our medical device company customers/partners.
  • Review and approve changes to currently marketed devices to determine impact to regulatory clearances / approvals.
  • Answer customer questions and provide letters/other documentation as is appropriate.
  • Support Notified Body and other regulatory agency audits.
  • Review and approve the rationale for reporting complaints to regulatory agencies and/or customers.
  • Ensure understanding of all quality policy/system items that are applicable.
  • Review and/or approve customer agreements for regulatory language that is relevant to the services provided.
  • Ensure that the information provided through the FURLS registration system with the FDA and the MDALL database in Health Canada is up-to-date and accurate regarding establishments licensing, owner/operator and medical device listings.
  • Update GUDID and/or EUDAMED database as needed for new and existing products.

What We're Looking For:

  • Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Pharmacy, Biology, or Chemistry and 5 years of experience as a Medical Device Regulatory Affairs Specialist, Medical Device Quality Engineer, or Medical Device Design Engineer
  • Alternatively, Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Pharmacy, Biology, or Chemistry 2 years of experience as a Medical Device Regulatory Affairs Specialist, Medical Device Quality Engineer, or Medical Device Design Engineer
  • The five years of experience with a Bachelor's degree or the two years of experience with a Master's degree must consist of experience with US and International medical device regulatory submissions, working with PMA or 510(k) devices, FDA, EU MDR, Health Canada, MHRA, MHLW, and TGA requirements, interactions with regulatory body/agency, and Vigilance/Adverse Event Medical Device Reporting.

Medevio is committed to providing competitive total compensation and benefits packages. The expected hiring range for this position is between $110,178 and $120,000/year based upon a full-time schedule. This is a good faith estimate on the applicable range. Base salaries are determined by taking a variety of factors in account, including, but not limited to, candidate qualifications, geographic locations, market conditions and internal equity. This position is bonus eligible, with a target bonus of 10%. Our total compensation package includes eligibility for comprehensive medical, dental, and vision coverage, a 401(k) plan with company match, education reimbursement, paid parental leave and paid time off.

Curious? Apply now!

Heraeus is proud to be an employer that provides equal access to opportunities for all its employees. We provide fair and equal consideration to all qualified applicants, regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, physical or mental disability, protected veteran status, age, or any other legally protected characteristic. A diverse and inclusive culture is at the heart of our Vision, Mission, and Values. We are dedicated to cultivating a workforce that reflects a broad spectrum of cultures, backgrounds, and perspectives.

We participate in E-Verify to confirm employment eligibility after hire. Learn more at www.e-verify.gov

Any further questions?

If you need any assistance or have questions, please contact hrdirect-americas@heraeus.com or visit our website at jobs.heraeus.com.

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