Saint Paul, MN · On-site
$77K - $124K/yr
The Biomedical Engineer, Design Assurance, is part of the product design and development team and ensures quality and regulatory compliance throughout the medical device lifecycle for class I and II ...
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Saint Paul, MN · On-site
$77K - $124K/yr
The Biomedical Engineer, Design Assurance, is part of the product design and development team and ensures quality and regulatory compliance throughout the medical device lifecycle for class I and II ...
About the Department The UMN Biomedical Engineering Department (BMED) is a dynamic and ... Enhance recognition of the department on national and international stages; * Together with ...
About the Department The UMN Biomedical Engineering Department (BMED) is a dynamic and ... Enhance recognition of the department on national and international stages; * Together with ...
Plymouth, MN · On-site
$90 - $120/hr
... international regulations and guidance Requirements * BS in Mechanical, Plastics, Biomedical ... Proficient in utilizing engineering tools and methodologies to translate user needs into product ...
New
Plymouth, MN · On-site
$90 - $120/hr
... international regulations and guidance Requirements * BS in Mechanical, Plastics, Biomedical ... Proficient in utilizing engineering tools and methodologies to translate user needs into product ...
New
Rochester, MN · On-site
$148K/yr
Qualifications BS in Engineering or a related field (Biomedical Engineering preferred) and 5 years ... International Assignment No Site Description Just as our reputation has spread beyond our Minnesota ...
Rochester, MN · On-site
$148K/yr
Qualifications BS in Engineering or a related field (Biomedical Engineering preferred) and 5 years ... International Assignment No Site Description Just as our reputation has spread beyond our Minnesota ...
Rochester, MN · On-site
$106K - $145K/yr
... biomedical-related engineering systems, applying knowledge of complex principles, theories ... and at our international locations. Each Mayo Clinic location is a special place where our ...
Rochester, MN · On-site
$106K - $145K/yr
... biomedical-related engineering systems, applying knowledge of complex principles, theories ... and at our international locations. Each Mayo Clinic location is a special place where our ...
Rochester, MN · On-site
$95K - $131K/yr
... biomedical-related engineering systems, applying knowledge of complex principles, theories ... and at our international locations. Each Mayo Clinic location is a special place where our ...
Rochester, MN · On-site
$95K - $131K/yr
... biomedical-related engineering systems, applying knowledge of complex principles, theories ... and at our international locations. Each Mayo Clinic location is a special place where our ...
Minneapolis, MN · On-site
$15.25 - $60/hr
The Department of Biomedical Engineering at the University of Minnesota occasionally needs to hire ... Paul benefit from extensive partnerships with world-renowned health centers, international ...
Minneapolis, MN · On-site
$15.25 - $60/hr
The Department of Biomedical Engineering at the University of Minnesota occasionally needs to hire ... Paul benefit from extensive partnerships with world-renowned health centers, international ...
Minneapolis, MN · On-site
$15.25 - $60/hr
About the Job The Department of Biomedical Engineering at the University of Minnesota occasionally ... Paul benefit from extensive partnerships with world-renowned health centers, international ...
Minneapolis, MN · On-site
$15.25 - $60/hr
About the Job The Department of Biomedical Engineering at the University of Minnesota occasionally ... Paul benefit from extensive partnerships with world-renowned health centers, international ...
Rochester, MN · On-site
$71K - $84K/yr
Mostafa Fatemi (Department of Physiology and Biomedical Engineering). Using state-of-the-art ... Friday International Assignment No Site Description Just as our reputation has spread beyond our ...
Rochester, MN · On-site
$71K - $84K/yr
Mostafa Fatemi (Department of Physiology and Biomedical Engineering). Using state-of-the-art ... Friday International Assignment No Site Description Just as our reputation has spread beyond our ...
... Based | Local & Domestic Travel Siemens Healthineers is building a strong pipeline of Medical ... biomedical engineer) servicing diagnostic instruments needed. * Valid driver's license, ability to ...
... Based | Local & Domestic Travel Siemens Healthineers is building a strong pipeline of Medical ... biomedical engineer) servicing diagnostic instruments needed. * Valid driver's license, ability to ...
Plymouth, MN Duration: 12 Months Workers can be remote/hybrid but must be local and able to come ... Experience and/or Background * BS in Mechanical, Plastics, Biomedical Engineering or a related ...
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Plymouth, MN Duration: 12 Months Workers can be remote/hybrid but must be local and able to come ... Experience and/or Background * BS in Mechanical, Plastics, Biomedical Engineering or a related ...
Minneapolis, MN · On-site +1
$55K - $76K/yr
... biomedical engineer) servicing diagnostic instruments needed. * Valid driver's license, ability to ... state/local law). #LI-DC1 Who we are : We are a team of more than 72,000 highly dedicated ...
Minneapolis, MN · On-site +1
$55K - $76K/yr
... biomedical engineer) servicing diagnostic instruments needed. * Valid driver's license, ability to ... state/local law). #LI-DC1 Who we are : We are a team of more than 72,000 highly dedicated ...
... biomedical engineer) servicing diagnostic instruments needed. * Valid driver's license, ability to ... state/local law). #LI-DC1 Who we are : We are a team of more than 72,000 highly dedicated ...
... biomedical engineer) servicing diagnostic instruments needed. * Valid driver's license, ability to ... state/local law). #LI-DC1 Who we are : We are a team of more than 72,000 highly dedicated ...
Plymouth, MN · On-site
$96K - $118K/yr
... international regulations and guidance. Qualifications : * To perform this job successfully, an ... Biomedical Engineering or a related field, MS preferred. * With minimum of 2 years of relevant ...
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Plymouth, MN · On-site
$96K - $118K/yr
... international regulations and guidance. Qualifications : * To perform this job successfully, an ... Biomedical Engineering or a related field, MS preferred. * With minimum of 2 years of relevant ...
Moundsview, MN · On-site
$25 - $27/hr
Ensure compliance with FDA and international (OUS) regulatory requirements. * Maintain complaint ... Degree in Nursing, Biology, Pre-Med, Pre-Vet, Biomedical Engineering, or Biomedical Sciences.
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Moundsview, MN · On-site
$25 - $27/hr
Ensure compliance with FDA and international (OUS) regulatory requirements. * Maintain complaint ... Degree in Nursing, Biology, Pre-Med, Pre-Vet, Biomedical Engineering, or Biomedical Sciences.
... be local and able to come into the office at least three days a week Summary: * This section ... Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field ...
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... be local and able to come into the office at least three days a week Summary: * This section ... Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field ...
Woodbury, MN · On-site
$10K - $12K/mo
... engineering, biomedical engineering, or the like. The preferred candidate should be a persuasive ... S. export control laws, including the International Traffic in Arms Regulations (ITAR). To be ...
Woodbury, MN · On-site
$10K - $12K/mo
... engineering, biomedical engineering, or the like. The preferred candidate should be a persuasive ... S. export control laws, including the International Traffic in Arms Regulations (ITAR). To be ...
Woodbury, MN · On-site
$10K - $12K/mo
... engineering, biomedical engineering, or the like. The preferred candidate should be a persuasive ... S. export control laws, including the International Traffic in Arms Regulations (ITAR). To be ...
Woodbury, MN · On-site
$10K - $12K/mo
... engineering, biomedical engineering, or the like. The preferred candidate should be a persuasive ... S. export control laws, including the International Traffic in Arms Regulations (ITAR). To be ...
Saint Paul, MN · On-site
Career development with an international company where you can grow the career you dream of ... Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering ...
Saint Paul, MN · On-site
Career development with an international company where you can grow the career you dream of ... Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering ...
Plymouth, MN · On-site
$104K - $156K/yr
... and international regulations and guidance. * May supervise engineers and/or technicians ... Experience and/or Background * BS in Mechanical, Plastics, Biomedical Engineering or a related ...
Plymouth, MN · On-site
$104K - $156K/yr
... and international regulations and guidance. * May supervise engineers and/or technicians ... Experience and/or Background * BS in Mechanical, Plastics, Biomedical Engineering or a related ...
| Aspect | Local International Biomedical Engineer | Clinical Biomedical Engineer |
|---|---|---|
| Credentials | Biomedical engineering degree, certifications like CBET or BIOMEDE | Biomedical engineering degree, certifications like CBET or BIOMEDE |
| Work Environment | Hospitals, clinics, medical device companies, international settings | Hospitals, healthcare facilities, medical device maintenance |
| Employer & Industry | Global medical device firms, healthcare organizations, international agencies | Hospitals, healthcare providers, medical equipment companies |
The Local International Biomedical Engineer typically works across various countries or regions, focusing on international standards and diverse healthcare environments. In contrast, the Clinical Biomedical Engineer primarily operates within local hospitals or clinics, maintaining and troubleshooting medical equipment on-site. Both roles require similar credentials but differ mainly in scope and work setting.
$77K - $124K/yr
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 22 days ago
What You’ll Do:
The Biomedical Engineer, Design Assurance, is part of the product design and development team and ensures quality and regulatory compliance throughout the medical device lifecycle for class I and II reusable surgical instruments and disposable medical devices, and supports the implementation and management of the digital requirements management system. This position reports to the Director of R&D Engineering.
40% Lead Design Assurance For Representation & Compliance
• Represent product quality and compliance in new product development and sustaining engineering projects.
• Ensure design and process controls meet regulatory and customer requirements.
• Implement medical device requirements management software (Jama) to organize and effectively manage the company’s design and development files.
• Create and update controlled documents (QSPs, specifications, methods) within the Quality Management System.
30% Product Testing
• Develop and execute implementation, inspection, and test plans for design transfer.
• Support R&D with verification/validation protocols, specifications, and reliability testing.
• Coordinate external validation activities (e.g., mechanical, functional, biocompatibility, sterilization).
20% Risk Management & Reviews
• Lead risk management activities (FMEA, hazard analysis, FTA, statistical analysis).
• Participate in design reviews and change control processes.
20% Technical Guidance & Design Principles
• Provide technical guidance on product quality attributes.
• Apply Design-to-Cost and Design-for-Manufacturability principles.
The Experience, Skills and Abilities Required:
• Bachelor of Science in Mechanical Engineering or Biomedical Engineering
• Minimum of 3+ years design assurance or product development.
• Understanding of ISO 13485 and FDA 21 CFR 820 compliance.
• Experience with full design lifecycle and phase-gate processes.
• Understanding of FMEAs, DOEs and Risk Assessment methods
• Strong written and verbal skills for documentation, presentations, and team alignment.
• Problem-Solving & Critical Thinking: Analytical skills to identify gaps, assess risks, and draw conclusions.
• High degree of accuracy in documentation and reviews.
• Working effectively in cross-functional teams (design, manufacturing, regulatory).
Preferred Experience, Skills and Abilities:
• Experience in medical devices
• Jama Connect requirements management software
• Minitab statistical analysis software
• Knowledge of quality methodologies (Six Sigma, DFSS, DMAIC).
• Project Management, time management, prioritization, and execution.
• Leadership, mentoring, and fostering a quality culture.
This position is based out of our corporate office, south of downtown St. Paul. We welcome an on-site work environment Monday through Friday.
Compensation
We are committed to equitable and transparent pay practices. The salary range for this position is $77,700 - $124,400, representing the minimum and maximum of our compensation structure. Starting pay will typically fall between these values and is determined based on factors such as relevant experience, skills, and internal equity. Offers near the higher end of the range are reserved for candidates with exceptional qualifications.
Comprehensive Benefits Offerings
- Medical, Dental, and Vision Insurance
- Group Life Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- 401(k) Plan with Company Match
- Workers' Compensation
- Employee Assistance Program (EAP)
- Regular Part-Time Benefit Eligibility
- Training and Development Program
- Tuition Assistance Program
- Paid Time Off, including holidays, floating holidays, vacation and Earned Sick and Safe Time (ESST)
