Product 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

Working at Freudenberg: We will wow your world!

Responsibilities:

• Assist in the design and development of new and existing medical devices by developing specifications, prototypes, and design documentation in compliance with regulatory and quality requirements.
• Support the preparation of design/development documentation; participate in risk assessments, design/project reviews, and verification testing to ensure product safety and efficacy.
• Assist in the build and testing of prototype devices, select appropriate materials, and assist with developing processes, test methods and characterization studies.
• Collaborate cross-functionally with NPI, manufacturing, quality, regulatory, suppliers and customers to learn and support design/process activities that ensure manufacturability, regulatory compliance, and cost-effectiveness.
• Assist in the preparation and maintenance of design/development documentation, in accordance with ISO, applicable regulatory and company standards.
• Participate in project execution by managing tasks, participating in team meetings, maintaining accurate engineering documentation, and coordinating testing activities with internal and external partners to meet project timelines and deliverables.
• Support product launches by providing engineering input during transition to NPI/ production, resolving technical issues, and contributing to continuous improvement efforts.
• Contribute to early-stage innovation efforts by researching new technologies and supporting technical feasibility assessments under the guidance of senior engineers.
• Ability to manage multiple tasks and adapt to a changing, fast-paced environment.

Qualifications:

• Bachelor's/University degree in Engineering (Mechanical, Biomedical, etc.), or related science/technical field.
• 0-3 years of engineering in medical device or related industry experience (or Internship or academic experience).
• Familiarity with GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements.
• Working knowledge or coursework in 3D solid modeling and technical drawings
• Basic understanding of creating prototypes using various materials and techniques to test and validate product designs.
• Awareness of Design for Manufacturability (DFM) principles to design products that are manufacturable and cost effective.
• Ability to communicate technical ideas clearly, ask thoughtful questions, and document work accurately.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical LLC