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Research And Development Engineer Medical Device Jobs in Wisconsin

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.

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.

New

GoMacro

R&D Manager

Madison, WI · On-site

Working closely with Manufacturing, Engineering, Marketing, Innovation, FSQA, Procurement, Project ... package, including medical, dental, vision, retirement, paid time off, and wellness-focused ...

GoMacro LLC

R&D Manager

Madison, WI · On-site

Working closely with Manufacturing, Engineering, Marketing, Innovation, FSQA, Procurement, Project ... package, including medical, dental, vision, retirement, paid time off, and wellness-focused ...

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All JobsResearch And Development Engineer Medical Device JobsResearch And Development Engineer Medical Device Jobs in Wisconsin

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.

Integration (Process Validation) Engineer

Vonco Products LLC

Trevor, WI • On-site

$70K - $85K/yr

Full-time

Re-posted 26 days ago

Job description

Description:

Integration (Process Validation) Engineer

Medical Device Contract Manufacturer – Flexible Films & Packaging


Position Summary

The Integration (Process Validation) Engineer is responsible for leading and supporting process validation and manufacturing integration activities for medical device packaging, flexible film converting, and related manufacturing processes. This role ensures manufacturing processes are developed, validated, transferred, and maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, customer requirements, and internal quality standards.

The engineer will work cross-functionally with Operations, Quality, Design Engineering, and customers to support new product introductions, process improvements, equipment qualifications, and ongoing manufacturing validation activities.


Reporting Structure

• Reports To: VP of Quality and Integration Engineering

• Department: Integration Engineering


Essential Duties and Responsibilities

• Develop and execute IQ, OQ, and PQ validation protocols and reports.

• Lead validation activities for flexible film converting, RF welding, heat sealing, pouch manufacturing, printing, and labeling operations.

• Perform process capability studies and statistical analysis to support validation activities.

• Establish process windows, critical process parameters, and acceptance criteria.

• Support new product introductions (NPI) from concept through commercial production.

• Identify and implement process improvements focused on quality, efficiency, scrap reduction, and throughput.

• Lead root cause investigations and corrective actions related to process performance.

• Ensure compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485, GMP requirements, and customer-specific quality requirements.

• Support internal, customer, and regulatory audits.

Project Management & Customer Communication

• Lead cross-functional project activities related to process validation, equipment implementation, and new product integration.

• Develop and manage project timelines, deliverables, and validation schedules to support customer and internal milestones.

• Coordinate activities between Engineering, Quality, Operations, Supply Chain, and customer teams to ensure successful project execution.

• Serve as a primary technical point of contact for customers during new product introductions, validation activities, process transfers, and ongoing manufacturing support.

• Communicate project status, technical risks, validation progress, and issue resolution plans to internal leadership and customers.

• Facilitate customer meetings, technical reviews, and validation planning discussions.

• Support quotation reviews and provide technical input related to manufacturability, process capability, and validation requirements.

• Collaborate with customers to understand product requirements, critical-to-quality characteristics, and regulatory expectations.

• Support customer visits, audits, factory acceptance activities, and production trials as needed.



Requirements:

Required Qualifications

• Bachelor’s degree in Engineering or related technical field required.

• 3+ years of engineering experience in a regulated manufacturing environment.

• Experience with process validation in regulated manufacturing.

• Working knowledge of IQ/OQ/PQ methodologies, statistical analysis, root cause analysis tools, and risk management methodologies.

• Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.

• Strong technical writing and documentation skills.

Preferred Qualifications

• Experience in flexible films, medical packaging, or converting operations.

• Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.

• Experience supporting customer audits and regulatory inspections.

• Experience with EQMS systems.

Key Competencies

• Strong analytical and problem-solving skills

• Project management and organizational skills

• Attention to detail and documentation accuracy

• Effective communication and collaboration skills

• Ability to manage multiple priorities in a fast-paced manufacturing environment

• Customer-focused mindset