Medical Device Development Engineer I

freudenberg; Minnetonka (MN); On-site; USD 60,000 - 80,000; Full time

Job summary

Freudenberg Medical LLC in Minnesota seeks an entry-level engineer to assist in designing and developing medical devices. You will create specifications, prototypes, and design documentation while aligning with regulatory and quality requirements.

You will support risk assessments, reviews, and verification testing to ensure product safety and efficacy. Collaboration across NPI, manufacturing, quality, regulatory, and suppliers will help ensure manufacturability and cost efficiency.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical) or related field.
• 0-3 years of engineering experience in medical devices or related internships/academic experience.
• Familiarity with GMP principles and regulatory requirements.
• Working knowledge of 3D solid modeling and technical drawings.
• Basic understanding of prototyping using various materials and techniques.
• Awareness of Design for Manufacturability (DFM) to ensure manufacturability and cost efficiency.
• Ability to communicate technical ideas clearly and document work accurately.

Responsibilities

• Assist in the design and development of medical devices by creating specifications, prototypes, and design documentation.
• Support preparation of design/development docs; participate in risk assessments, design reviews, and verification testing for safety and efficacy.
• Assist build/testing of prototype devices; select materials; help develop processes, test methods, and characterization studies.
• Collaborate cross-functionally with NPI, manufacturing, quality, regulatory, suppliers and customers to ensure manufacturability and regulatory compliance.
• Prepare and maintain design/development documentation in accordance with ISO and company standards.
• Participate in project execution; manage tasks, attend team meetings, and coordinate testing with internal/external partners to meet timelines.
• Support product launches by providing engineering input during transition to NPI/production and contributing to continuous improvement.
• Contribute to early-stage innovation through researching new technologies and feasibility assessments under senior engineers guidance.

Skills

GMP knowledge

3D modeling

Technical drawings

Prototype testing

DFM principles

Documentation

Education

Bachelor's degree in Engineering (Mechanical, Biomedical)

Job description

Freudenberg Medical LLC in Minnesota seeks an entry-level engineer to assist in designing and developing medical devices. You will create specifications, prototypes, and design documentation while aligning with regulatory and quality requirements.

You will support risk assessments, reviews, and verification testing to ensure product safety and efficacy. Collaboration across NPI, manufacturing, quality, regulatory, and suppliers will help ensure manufacturability and cost efficiency.