Senior R&D Engineer

Actalent; Plymouth (MN); Hybrid; USD 88,000 - 121,000; Full time

Job summary

Actalent in Plymouth, MN is seeking a Mechanical/ Biomedical Engineer to support design changes for Class II/III disposable medical devices within a sustaining engineering environment. You will drive device improvements, verify performance, and ensure regulatory compliance with FDA and ISO standards.

Responsibilities include developing test methods, creating design docs, collaborating across functions, and contributing to CAPA and risk management initiatives.

Qualifications

• Bachelor's degree in Mechanical, Plastics, Biomedical Engineering, or related field.
• 3+ years of experience with Class II/III disposable medical devices.
• Experience with sustaining engineering and change management.
• Knowledge of plastics manufacturing: injection molding, extrusion, bonding, sterilization.
• Proficiency with CAD tools such as Creo or SolidWorks.
• Understanding of FDA Design Controls, ISO quality systems, and medical device risk management.
• Strong problem-solving, communication, and project management skills.

Responsibilities

• Lead and support design changes for disposable medical devices, including materials, suppliers, features, labeling updates, CAPA actions, and cost reduction initiatives.
• Develop and execute test methods, product testing, and verification/validation activities.
• Create and maintain design documentation, specifications, drawings, protocols, and reports.
• Apply risk management tools, dFMEA, Human Factors Engineering, and statistical analysis to solve engineering challenges.
• Design and build prototypes, tooling, fixtures, and test equipment as needed.
• Use CAD tools (Creo/SolidWorks) to develop and maintain product designs.
• Collaborate with cross-functional teams to ensure projects are completed on time and in compliance with FDA and ISO requirements.
• Support continuous improvement initiatives and best practices within R&D and sustaining engineering.

Skills

CAD experience

Project management

Problem solving

Communication

Education

Bachelor's in Mechanical/ Biomedical Eng

Tools

Creo/SolidWorks

Job description

Position Summary

Support the design, development, and implementation of product changes for Class II and III disposable medical devices within a sustaining engineering environment. This role focuses on improving product performance, ensuring regulatory compliance, and driving continuous improvement in support of life-saving kidney care therapies.

Key Responsibilities

• Lead and support design changes for disposable medical devices, including new materials, suppliers, features, labeling updates, CAPA actions, and cost reduction initiatives.

• Develop and execute test methods, product testing, and verification/validation activities.

• Create and maintain design documentation, specifications, drawings, protocols, and reports.

• Apply risk management tools, dFMEA, Human Factors Engineering, and statistical analysis to solve engineering challenges.

• Design and build prototypes, tooling, fixtures, and test equipment as needed.

• Use CAD tools (Creo/SolidWorks) to develop and maintain product designs.

• Collaborate with cross-functional teams to ensure projects are completed on time and in compliance with FDA and ISO requirements.

• Support continuous improvement initiatives and best practices within R&D and sustaining engineering.

Required Qualifications

• Bachelor's degree in Mechanical, Plastics, Biomedical Engineering, or a related field.

• 3+ years of experience developing or supporting Class II/III disposable medical devices.

• Experience with sustaining engineering and product change management.

• Knowledge of plastics manufacturing processes, including injection molding, extrusion, bonding, and sterilization.

• Proficiency with CAD tools such as Creo or SolidWorks.

• Understanding of FDA Design Controls, ISO quality systems, and medical device risk management.

• Strong problem-solving, communication, and project management skills.

Preferred Qualifications

• Master's degree in Engineering.

• DFSS training or certification.

• Advanced SolidWorks experience.

• Experience with prototype development, validation testing, CAPA/NCR activities, and design history documentation.

Job Type & Location

This is a Permanent position based out of Plymouth, MN.

Pay and Benefits

The pay range for this position is $88000.00 - $121000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Will get benefits from customer when needed

Workplace Type

This is a hybrid position in Plymouth,MN.

Application Deadline

This position is anticipated to close on Oct 21, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.