Senior New Product Development Engineer

Real; Minneapolis (MN); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work environment

4 weeks PTO

Parental Leave

Medical, dental, and vision coverage

Job summary

Real is seeking a Senior New Product Development Engineer in Minnesota to drive the development of innovative disposable medical technologies from concept to launch. You will lead projects, optimize designs, and ensure regulatory compliance within a global team.

The role requires 3+ years in medical device product development, expertise in design controls and risk management, and hands-on CAD experience (Creo/SolidWorks). A B.S.

Qualifications

• 3+ years of medical device product development experience.
• Experience supporting Class II and/or Class III medical devices.
• Strong understanding of design controls, risk management, and regulated product development.
• Hands-on experience with plastics and manufacturing processes such as injection molding, extrusion, bonding, or sterilization.

Responsibilities

• Lead and support engineering projects from concept through implementation.
• Drive product design changes, enhancements, and continuous improvement initiatives.
• Investigate and resolve technical challenges using risk-based engineering methodologies.
• Partner with cross-functional stakeholders across Quality, Manufacturing, Regulatory, and Operations.
• Develop and execute verification, validation, and test method activities.
• Create and maintain technical documentation supporting product development and design controls.
• Build prototypes, evaluate product performance, and support engineering testing.
• Ensure compliance with medical device regulations and quality system requirements.

Skills

Medical device development

Design controls

Risk management

Regulated product development

Education

Bachelor's degree in Mechanical Engineering

Tools

Creo

SolidWorks

Injection molding

Extrusion

Bonding

Sterilization

Job description

Ready to make a direct impact on products that improve patient outcomes? We're partnering with an industry-leading medical device organization seeking a Senior New Product Development Engineer to join a high-performing team focused on advancing and enhancing innovative disposable medical technologies.

In this role, you'll work on a variety of engineering initiatives ranging from product improvements and design changes to remediation, cost optimization, supplier transitions, and next-generation enhancements. If you enjoy solving complex technical challenges in a regulated environment and collaborating across global teams, this could be an excellent fit.

What You'll Be Doing

• Lead and support engineering projects from concept through implementation
• Drive product design changes, enhancements, and continuous improvement initiatives
• Investigate and resolve technical challenges using risk-based engineering methodologies
• Partner with cross-functional stakeholders across Quality, Manufacturing, Regulatory, and Operations
• Develop and execute verification, validation, and test method activities
• Create and maintain technical documentation supporting product development and design controls
• Build prototypes, evaluate product performance, and support engineering testing
• Ensure compliance with medical device regulations and quality system requirements

What We're Looking For

• 3+ years of medical device product development experience
• Experience supporting Class II and/or Class III medical devices
• Strong understanding of design controls, risk management, and regulated product development
• Hands-on experience with plastics and manufacturing processes such as injection molding, extrusion, bonding, or sterilization
• Proficiency with CAD systems such as Creo or SolidWorks
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics Engineering, or a related field

Why Consider This Opportunity?

• Join a recognized medical device innovator with a strong pipeline of products
• Work on meaningful technologies that impact patient care
• Collaborate with talented engineers and cross-functional leaders
• Gain exposure to a diverse range of engineering and product development projects
• Competitive compensation, benefits, and long-term career growth potential
• Strong Benefits: Hybrid work environment, 4 weeks of PTO, Parental Leave, and full medical, dental, and visiton coverage.

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.

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.