Product Development Engineer I

Freudenberg Group • Minnetonka, MN

11d

About The Position

The Product Development Engineer I will assist in the design and development of new and existing medical devices. This role involves developing specifications, prototypes, and design documentation in compliance with regulatory and quality requirements. The engineer will support the preparation of design/development documentation, participate in risk assessments, design/project reviews, and verification testing to ensure product safety and efficacy. They will also assist in the build and testing of prototype devices, select appropriate materials, and help develop processes, test methods, and characterization studies. Collaboration with NPI, manufacturing, quality, regulatory, suppliers, and customers is key to ensuring manufacturability, regulatory compliance, and cost-effectiveness. The role requires managing tasks, participating in team meetings, maintaining accurate engineering documentation, and coordinating testing activities to meet project timelines. Support for product launches, resolving technical issues, and contributing to continuous improvement efforts are also expected. Additionally, the engineer will contribute to early-stage innovation by researching new technologies and supporting technical feasibility assessments under the guidance of senior engineers. The ability to manage multiple tasks and adapt to a changing, fast-paced environment is essential.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level