Product Development Engineer I

Freudenberg Medical LLC; Minnetonka (MN); On-site; USD 65,000 - 90,000; Full time

Job summary

Freudenberg Medical LLC in Minnetonka, MN is seeking an engineer to assist in designing and developing medical devices, creating specifications, prototypes, and design documentation in line with regulatory and quality requirements.

You will participate in risk assessments, design reviews, verification testing, and collaborate with NPI, manufacturing, quality, regulatory, suppliers, and customers to ensure manufacturability, regulatory compliance, and cost-effectiveness.

Qualifications

• Bachelor's degree in Engineering or related field required.
• 0-3 years of engineering experience in medical device or related industry.
• Familiarity with GMP principles and their application in medical device manufacturing.

Responsibilities

• Assist in the design and development of medical devices by creating specifications, prototypes and design documentation.
• Support design/development documentation, participate in risk assessments, design/project reviews, and verification testing for safety and efficacy.
• Assist build and testing of prototype devices; select materials and help develop processes and test methods.

Skills

GMP knowledge

3D CAD (Solid modeling)

Technical drawings

Prototype testing basics

DFM awareness

Effective communication

Education

Bachelor's degree in Engineering (Mechanical, Biomedical, etc.)

Related science/technical field

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 Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.