Senior R&D Engineer

Real Staffing; Minneapolis (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Real Staffing is seeking a Senior R&D Engineer for a medical device client focusing on Class II/III disposable devices. You will lead projects from concept through implementation, driving quality, compliance and performance improvements in a regulated environment.

The role emphasizes risk-based methodologies, documentation, and collaboration with cross-functional teams to deliver robust engineering solutions and compliant products.

Qualifications

• Bachelor's degree in Mechanical/ Biomedical Engineering or related field.
• 3+ years developing or supporting Class II/III medical devices.
• Experience with disposable medical product design and sustaining engineering.

Responsibilities

• Lead and support projects on product improvements, compliance, quality and performance.
• Develop and maintain design specs, drawings, validation protocols and labeling docs.
• Plan and execute V&V, product testing and method validations.
• Ensure FDA, ISO 13485 design controls and risk management practices.

Skills

Project leadership

Cross-functional collaboration

Regulatory awareness

Quality mindset

Education

Bachelor's degree in Mechanical / Biomedical Engineering

Tools

Creo

SolidWorks

PDM systems

Job description

Senior R&D Engineer - Medical Devices

Are you passionate about designing products that improve lives? We're partnering with an innovative medical device organization seeking a Senior Product Development Engineer to support sustaining engineering initiatives for Class II and III disposable medical devices.

This is an opportunity to work on meaningful products, collaborate with global cross-functional teams, and drive engineering solutions from concept through implementation in a highly regulated environment.

What You'll Do

As a Senior R&D Engineer, you will lead and support engineering projects focused on product improvements, compliance, quality, and performance enhancements. Responsibilities include:

• Leading small to medium-sized projects involving:
  • Product enhancements and new features
  • Supplier and material changes
  • Labeling updates
  • CAPA/NCR activities
  • Cost reduction initiatives
  • Product remediation efforts

Identifying and solving complex engineering challenges using risk-based and customer-focused methodologies.

Developing and maintaining technical documentation, including:

• Design specifications
• Engineering drawings
• Validation protocols and reports
• Product labeling documentation

Planning and executing:

• Verification & Validation (V&V)
• Product testing
• Test method validations

Building prototypes and supporting fixture/tooling development for product evaluation and manufacturing support.

Ensuring compliance with FDA regulations, ISO standards, design controls, and quality system requirements.

What We're Looking For

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics Engineering, or a related discipline
• 3+ years of experience developing or supporting Class II and/or Class III medical devices
• Experience with disposable medical product design and sustaining engineering activities

Technical Expertise

• Plastics processing technologies including injection molding, extrusion, ultrasonic welding, bonding processes, and sterilization methods
• CAD and Product Data Management (PDM) platforms such as Creo or SolidWorks
• FDA Design Controls and ISO 13485 Quality Management Systems
• Risk Management practices aligned with ISO 14971

Professional Attributes

• Self-starter with a strong sense of ownership and accountability
• Innovative mindset with a passion for continuous improvement
• Strong communication and cross-functional collaboration skills
• Highly organized with excellent attention to detail
• Ability to manage multiple priorities in a fast-paced environment

Why This Opportunity?

You’ll join a team focused on delivering high-quality medical device solutions that make a real difference for patients and healthcare providers worldwide. If you enjoy solving complex engineering challenges, driving product improvements, and working in a collaborative environment, we’d love to connect.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com