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Research And Development Engineer Medical Device Jobs in Wisconsin

Kellton Tech

Medical Device Assembler

Madison, WI · On-site

$23 - $24/hr

Job Title: Medical Device Assembler Location: Madison, WI (Onsite) Pay Rate: $23-24/hr on W2 ... Engineering group as required. Working Conditions: Clean, temperature controlled environment.

Haemonetics Software Solutions

WI · On-site

$51 - $87/hr

... Engineer (FSE) will support the Blood Management Centers and Hospitals onsite in the field and provide ongoing customer support. This position is responsible for providing device installation ...

Kellton Tech

Medical Device Technician

Madison, WI · On-site

$38K - $48K/yr

Provide guidance in problem diagnosis and resolution with team members. * Assist in development and ... Bachelor's degree in engineering or related scientific field. Associate's degree with 2+ years ...

Experis

Medical Device Test Engineer

Waukesha, WI · On-site

As a Medical Device Test Engineer, you will be part of the Quality Assurance department supporting the testing and validation of medical devices used in invasive cardiology. The ideal candidate will ...

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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.

Computer / Software Engineer (Medical Device)

Mallinckrodt

Madison, WI • On-site

Full-time

Re-posted 9 days ago

Mallinckrodt rating

8.0

Company rating: 8.0 out of 10

Based on 11 frontline employees who took The Breakroom Quiz

43rd of 86 rated pharmaceutical

Job description

Job Title
Computer / Software Engineer (Medical Device)
Requisition
JR000015837 Computer / Software Engineer (Medical Device) (Open)
Location
Madison, WI
Additional Locations
Job Description Summary
We are seeking an experienced Computer / Software Engineer to support the Sustaining Engineering team responsible for maintaining and improving test systems, automated equipment, and supporting software used in the manufacture of FDA regulated medical devices for respiratory therapy. This role focuses on test and support systems not directly embedded in the therapeutic device, but which are essential for product verification, production workflows, and device commissioning.
The ideal candidate has strong software engineering skills, hands-on experience with automated test systems, and deep familiarity with regulated environments (FDA 21 CFR Part 820.72, GMP). They will ensure test system reliability, maintain compliance, support cybersecurity controls, and drive continuous improvement across manufacturing support technologies.
Job Description
Key Responsibilities:
Software Development & Test System Engineering
  • Develop, maintain, and optimize test and automation software using LabVIEW, NI TestStand, and Python.
  • Write efficient and scalable code in Python for backend testing, data processing, and hardware/software integration.
  • Design and implement software solutions that interface with sensors, industrial PCs, DAQ modules, and automated machinery.
  • Assist in developing test frameworks, scripts, and utilities used for software/system validation.
  • Debug complex code and system behavior across Windows 11, industrial PCs, and embedded device interfaces.

Systems Support & Troubleshooting
  • Diagnosing and resolving issues in complex test and measurement systems, including hardware/software interactions and system-level faults.
  • Support enterprise IT systems used for device commissioning, access control, configuration management, and backup/recovery processes.
  • Perform root cause analysis (RCA) on system failures and implement corrective and preventive actions (CAPA).

Cross-Disciplinary Engineering Support
  • Partner with Electrical and Mechanical Engineering teams to investigate complex system behaviors involving hardware-software integration.
  • Analyze ambiguous or intermittent production test issues where failures present in subtle, non-obvious ways to users or operators.
  • Develop software tools, instrumentation scripts, and diagnostic routines to capture hidden failure modes that traditional hardware diagnostics may not detect.
  • Contributes to the creation of advanced test strategies that correlate data across mechanical, electrical, and software subsystems.

Regulatory & Compliance Responsibilities
  • Work within FDA 21 CFR Part 820.72 and applicable GMP quality system requirements.
  • Ensures data integrity, cybersecurity protections, audit trails, and access controls are properly implemented in test systems.
  • Maintain clear, compliant documentation of code, workflows, and validation processes.
  • Participate in risk analysis and support validation/verification activities for test equipment and software tools.

Collaboration & Technical Leadership
  • Collaborate with cross-functional teams including Manufacturing Engineering, Quality, IT Security, and R&D.
  • Translate production and engineering needs into technical requirements for software and test systems.
  • Train users and provide engineering support for manufacturing personnel and test technicians.

Required Qualifications:
  • Bachelor's degree in Computer Engineering, Software Engineering, Electrical Engineering, or related field.
  • Strong proficiency in:
    • LabVIEW
    • Python
    • High-level languages (C++, Java) and associated development environments
    • Scripting languages for automation/test development
  • Experience working with:
    • Windows 11 OS and PC hardware architectures
    • Industrial PCs and automated test hardware
    • GitHub, source control, debuggers, build systems
    • TestStand or similar automated test frameworks
  • Hands-on experience debugging complex embedded or computerized systems.
  • Understanding of the software development lifecycle (SDLC).
  • Experience with root cause analysis, fault isolation, and system troubleshooting.
  • Familiarity with cybersecurity fundamentals related to:
    • Access control
    • Data protection
    • System administration
    • Networked test systems

Preferred Qualifications:
  • Prior experience in a medical device or other FDA-regulated industry.
  • Knowledge of data integrity requirements, ALCOA/ALCOA+ principles, and digital recordkeeping compliance.
  • Experience validating software or equipment under GxP frameworks.
  • Background in test equipment calibration, test method validation, or automated manufacturing tools

Soft Skills:
  • Strong communication and documentation abilities.
  • Detail-oriented with a disciplined approach to working within regulated processes.
  • Ability to manage multiple tasks, prioritize effectively, and collaborate across diverse teams.
  • Problem-solving mindset with a focus on system reliability and continuous

Organizational Relationship/Scope:
This position operates cross-functionally and collaborates regularly with Product Performance, Complaint Management, Service Support, Device Quality, Post-Market Surveillance, Device Development, and Materials Management, as well as external partners, to address product lifecycle challenges and support new product introductions.
This is an advanced role requiring deep technical understanding of products and therapy across multiple use cases, along with the ability to interpret and balance stakeholder needs. The position serves as a key technical resource, providing guidance, influencing decisions, and driving alignment across functions to ensure effective resolution of complex product issues.
Working Conditions:
This role operates across a range of environments, including office, engineering laboratory, and medical device manufacturing areas, supporting hands-on investigation, testing, and product support activities.
The position requires engagement with both development and production settings to diagnose issues, validate design and process changes, and support ongoing product lifecycle needs.
Domestic and international travel of up to 20% may be required to support manufacturing sites, suppliers, and field issue investigations.
Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
#LI-GN1
At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.
We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.
We are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com.

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