Product Development Engineer I

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Benefits

• 401K Match: Save for retirement with the company's help.
• Sustainability & Social Commitment: Support social and sustainable projects and encourage employee involvement.
• Diversity & Inclusion: Focus on providing an inclusive environment and recognize diversity contributes to success.
• Personal Development: Variety of trainings to ensure career development.
• Employee discounts: Opportunities for deals on products and services.
• Comprehensive benefits package including medical, dental, and vision coverage.
• Retirement savings with company match.
• Paid time-off.

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.

Requirements

• 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.

Candidates must be legally authorized to work in the United States without current or future visa sponsorship.

Pay

The expected salary range for this position is $75,000 to $90,000 USD annually, depending on skills, experience, and qualifications.

Location: Minnetonka, MN (On-Site)