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Research And Development Engineer Medical Device Jobs in Wisconsin

Verily Life Sciences LLC

WI · On-site

$113 - $170/hr

... research, and medical device (SaMD) product portfolio. This role champions quality and security throughout the software development lifecycle - partnering closely with engineering, security, and ...

Grande

Research & Development Intern

Fond Du Lac, WI · On-site

$14.75 - $19.75/hr

Student in Sophomore or greater status working towards a degree in a science or engineering related ... Interest in Research & Development, New Product Development, Sensory Analysis, and/or Microbiology.

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Research And Development Engineer Medical Device information

What does a research and development engineer do in the medical device industry?

A Research and Development (R&D) Engineer in the medical device industry is responsible for designing, developing, and testing new medical devices and technologies. They work closely with cross-functional teams to ensure products meet regulatory standards, are safe for patient use, and address clinical needs. Their tasks may include prototyping, conducting experiments, analyzing data, and collaborating with manufacturing teams to bring products from concept to market. R&D Engineers also stay updated on technological advancements and regulatory changes to ensure innovation and compliance.

What are the key skills and qualifications needed to thrive as a research and development engineer in the medical device industry?

To excel as a Research and Development Engineer in Medical Devices, you need a solid background in biomedical engineering or a related field, strong problem-solving skills, and experience with product development cycles. Familiarity with CAD software, prototyping tools, regulatory standards like ISO 13485, and relevant certifications (such as Six Sigma) is highly valued. Excellent teamwork, creativity, and effective communication are crucial soft skills for collaborating across multidisciplinary teams and driving innovation. These competencies ensure the design and launch of safe, effective, and compliant medical devices that improve patient outcomes.

What are some common challenges faced by research and development engineers in the medical device industry?

Research and Development Engineers in the medical device industry often face challenges such as navigating complex regulatory requirements, managing tight project timelines while ensuring product safety and efficacy, and collaborating with cross-functional teams like quality assurance and clinical affairs. Additionally, adapting to rapid technological advancements and integrating feedback from clinicians and end-users into the design process can be demanding. These challenges require strong problem-solving skills, adaptability, and effective communication to deliver innovative and compliant medical devices.

What is the difference between Research And Development Engineer Medical Device vs Quality Assurance Engineer Medical Device?

AspectResearch And Development Engineer Medical DeviceQuality Assurance Engineer Medical Device
Primary FocusDesigning, developing, and testing new medical device productsEnsuring products meet quality standards and regulatory requirements
Required CredentialsEngineering degree, knowledge of product developmentEngineering or science degree, knowledge of quality systems
Work EnvironmentResearch labs, product development teamsManufacturing facilities, quality control departments
Industry UsageInvolved in innovation and product creationInvolved in compliance, validation, and process improvement

While both roles require engineering knowledge and are integral to the medical device industry, Research And Development Engineers focus on creating and testing new products, whereas Quality Assurance Engineers ensure these products meet safety and quality standards throughout production.

What are popular job titles related to Research And Development Engineer Medical Device jobs in Wisconsin?

For Research And Development Engineer Medical Device jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Research And Development Engineer Medical Device jobs in Wisconsin look for?

The top searched job categories for Research And Development Engineer Medical Device jobs in Wisconsin are:

What cities in Wisconsin are hiring for Research And Development Engineer Medical Device jobs?

Cities in Wisconsin with the most Research And Development Engineer Medical Device job openings:

Research And Development Engineer Medical Device jobs near you
Infographic showing various Research And Development Engineer Medical Device job openings in Wisconsin as of July 2026, with employment types broken down into 1% As Needed, 80% Full Time, 15% Part Time, and 4% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution.

Engineer, Device Engineering

Scorpion Therapeutics

Madison, WI • On-site

$120 - $145/hr

Other

Posted 5 days ago

Job description

Responsibilities:
  • Develop and execute strategies/roadmaps for drug-device combination product programs.
  • Provide technical leadership from concept through commercialization and lifecycle management.
  • Lead human factors/usability engineering; author/review plans, URRAs, protocols, reports, and design control documentation.
  • Lead formative/summative human factors evaluations and interpret results.
  • Provide technical expertise in drug delivery technologies, device/system engineering, design controls, risk management, materials, and manufacturing processes.
  • Lead development of prefilled syringes, autoinjectors, and other drug delivery systems.
  • Collaborate cross-functionally (Product Development, Packaging, Manufacturing, Clinical, Supply Chain, Commercial, Quality, Regulatory).
  • Oversee external testing labs; establish/maintain design control processes and DHF documentation.
  • Support design transfer (risk assessments, specs, control strategies, statistical evaluation).
  • Author/review combination-product regulatory submission sections (IND/IMPD/BLA/MAA).
  • Ensure compliance with FDA/EU requirements and standards (ISO 14971, ISO 13485, EU MDR); manage risks and vendors.
Requirements:
  • BS in Biomedical/Mechanical Engineering, Pharmaceutical Sciences, or related.
  • 8+ years in combination product/medical device development; concept-to-commercialization/lifecycle.
  • Experience commercializing prefilled syringes and autoinjectors.
  • Knowledge of subcutaneous delivery systems, device design, systems engineering, materials, manufacturing.
  • Experience with design controls, risk management, human factors/usability engineering.
  • Knowledge of FDA/EU regulations/quality systems (ISO 14971, ISO 13485, EU MDR).
  • Experience with device characterization/design verification testing and device regulatory submission content.
  • Strong communication, cross-functional influence, and project management.
Preferred:
  • Advanced degree.
  • Experience with biological drug products/primary packaging.
  • cGMP process development, manufacturing controls, process risk assessments, design transfer.
  • Fast-paced biotech/pharma experience; mentoring/technical leadership.
Compensation/Benefits:
  • Wisconsin pay range: $120,000–$145,000; California pay range: $135,000–$155,000.
  • Competitive salaries and an excellent benefit package.
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