Working at Freudenberg: We will wow your world!<h1>Responsibilities:</h1><ul><li>Execute the development, prototyping, and testing of new products/processes, including design verification, validation, and the creation of standard operating procedures (SOPs), test methods, and technical documentation.</li><li>Support planning and executing NPI projects from concept to commercialization, ensuring timelines, budgets, and customer requirements are met.</li><li>Collaborate with internal teams, customers, and suppliers to develop manufacturing processes, select materials, resolve technical issues, and support design for manufacturability.</li><li>Plan and execute process validation (IQ, OQ, PQ), risk assessments (per ISO 13485), and process control strategies to support robust product and process development. Support risk management activities (i.e., PFMEA) and ensure integration and alignment with applicable regulatory standards.  </li><li>Provide hands-on support for prototyping, pilot builds, process development, validation, transfer to production and troubleshooting, and collaborate with suppliers for materials, components, and equipment qualification.</li><li>Contribute to feasibility studies and evaluate new technology identification to ensure scalable, compliant manufacturing solutions.</li><li>Engage in cross-functional communication and external collaboration to align project goals, manage stakeholders, to facilitate NPI project timelines. and stay current with industry technologies and best practices.</li><li>Support management of QMS activities such as CAPA's, PAR's, NCMR's and other applicable items as required.</li></ul><h1>Qualifications:</h1><ul><li>Bachelor's/University degree in Engineering (Mechanical, Biomedical etc.)  or related science/technical field.  </li><li>3+ years’ experience in a medical device or related industry experience.</li><li>Understanding of relevant ISO standards, knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements.</li><li>Understanding of process validation principles and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols.  </li><li>Intermediate knowledge of quality control tools such as statistical process control (SPC) and root cause analysis.  </li><li>Familiarity with product testing and inspection methods to ensure compliance with specifications and standards.</li></ul>‎ ‎ 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

Freudenberg e-Power Systems is one of the world's leading suppliers of emission-neutral energy systems for heavy-duty applications. With its experience and expertise in battery and fuel cell technology, the company offers tailor-made solutions, in particular combined systems, for sustainable and economical e-mobility. With over 800 employees, Freudenberg e-Power Systems supports its customers from application development through to production, commissioning and service.
The company is part of the global Freudenberg Group, which has four business areas: Seals and Vibration Control Technology, Nonwovens and Filtration, Household Products as well as Specialties and Others. In 2022 the Group generated sales of more than 11 billion euros and employed more than 50,000 associates in around 60 countries.

New Product Introduction Engineer II - Med Device

Working at Freudenberg: We will wow your world!<h1>Responsibilities:</h1><ul><li>Execute the development, prototyping, and testing of new products/processes, including design verification, validation, and the creation of standard operating procedures (SOPs), test methods, and technical documentation.</li><li>Support planning and executing NPI projects from concept to commercialization, ensuring timelines, budgets, and customer requirements are met.</li><li>Collaborate with internal teams, customers, and suppliers to develop manufacturing processes, select materials, resolve technical issues, and support design for manufacturability.</li><li>Plan and execute process validation (IQ, OQ, PQ), risk assessments (per ISO 13485), and process control strategies to support robust product and process development. Support risk management activities (i.e., PFMEA) and ensure integration and alignment with applicable regulatory standards.  </li><li>Provide hands-on support for prototyping, pilot builds, process development, validation, transfer to production and troubleshooting, and collaborate with suppliers for materials, components, and equipment qualification.</li><li>Contribute to feasibility studies and evaluate new technology identification to ensure scalable, compliant manufacturing solutions.</li><li>Engage in cross-functional communication and external collaboration to align project goals, manage stakeholders, to facilitate NPI project timelines. and stay current with industry technologies and best practices.</li><li>Support management of QMS activities such as CAPA's, PAR's, NCMR's and other applicable items as required.</li></ul><h1>Qualifications:</h1><ul><li>Bachelor's/University degree in Engineering (Mechanical, Biomedical etc.)  or related science/technical field.  </li><li>3+ years’ experience in a medical device or related industry experience.</li><li>Understanding of relevant ISO standards, knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements.</li><li>Understanding of process validation principles and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols.  </li><li>Intermediate knowledge of quality control tools such as statistical process control (SPC) and root cause analysis.  </li><li>Familiarity with product testing and inspection methods to ensure compliance with specifications and standards.</li></ul>‎ ‎ 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

New Product Introduction Engineer II - Med Device

About the Job

About the Company

Freudenberg

Similar Jobs

Quality Engineer

Quality Engineer

Sr. Quality Engineer - Medical Manufacturing

Sr. Quality Engineer - Medical Manufacturing

Product Development Engineer I

Product Development Engineer I

Quality Engineer II

Quality Engineer II

Quality Engineer

Quality Engineer

Quality Engineer II

Quality Engineer II

Quality Engineer II

Quality Engineer II

Manufacturing Engineer II

Manufacturing Engineer II

Quality Engineer

Quality Engineer

Sr. Manufacturing Engineer

Sr. Manufacturing Engineer