A Product Development Engineer develops new products for companies, and participates in all phases of product development including research, design, production and marketing. Uses research on customer demand and industry trends to develop product ideas; builds and tests product prototypes; evaluates production options and costs. May specialize in a particular type of product or in products for a specific industry.
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
