Principal R&D Engineer

JCW Group; Maple Grove (MN); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading medical device company is seeking a Principal R&D Engineer to drive product development from concept to commercialization. In this role, you will lead cross-functional teams, mentor engineers, and manage multiple projects while ensuring compliance with quality and regulatory standards. The ideal candidate has over 7 years of experience in the medical device industry, a strong background in design controls, and is skilled in CAD tools. This position offers a chance to shape innovative medical solutions.

Qualifications

• 7+ years of product development experience in the medical device industry.
• Strong background in design controls, test method development, and materials/process selection.
• Working knowledge of applicable U.S. and international medical device standards.

Responsibilities

• Lead design and development of new devices complying with quality and regulatory requirements.
• Translate user needs into validated designs with specifications and test methods.
• Oversee verification, validation, and design transfer activities.

Skills

Design controls

Test method development

CAD (SolidWorks)

Leadership

Cross-functional team management

Education

Bachelor’s degree in Engineering or related field

Tools

Lab tools

Statistical methods

Job description

Seeking a Principal R&D Engineer to lead medical device product development from concept through commercialization. This role drives cross‑functional teams, mentors engineers, and plays a strategic role in shaping both products and processes.

Responsibilities

• Lead design and development of new devices in alignment with quality system and regulatory requirements
• Translate user needs into validated designs with clear specifications and robust test methods
• Oversee verification, validation, and design transfer activities
• Guide design reviews and ensure timely completion of deliverables
• Manage multiple projects and act as primary technical contact for leadership
• Mentor engineers and potentially supervise direct reports
• Collaborate with physicians, suppliers, and cross‑functional teams
• Identify department‑level process improvements and contribute to product strategy
• Support product line extensions and continuous improvement initiatives

Qualifications

• Bachelor’s degree in Engineering or related field
• 7+ years of product development experience in the medical device industry
• Strong background in design controls, test method development, and materials/process selection
• Skilled in CAD (SolidWorks), lab tools, and statistical methods
• Proven leadership and cross‑functional team management experience
• Working knowledge of applicable U.S. and international medical device standards

Preferred

• Expertise in catheter or minimally invasive device design and fabrication
• Experience from concept through commercialization
• Strong project management and mentoring capabilities