New Product Introduction Engineer II - Med Device

Freudenberg Medical LLC; Minnetonka (MN); On-site; USD 110,000 - 160,000; Full time

Job summary

Freudenberg Medical LLC in Minnesota is seeking a qualified engineer to lead development, prototyping, testing, and documentation for new medical devices. You will drive NPI initiatives from concept through commercialization, ensuring adherence to timelines and budgets.

Collaborate with internal teams and suppliers to create scalable manufacturing processes, perform IQ/OQ/PQ validations, and contribute to risk assessments and QMS activities to maintain product quality and regulatory compliance.

Qualifications

• Understanding of ISO standards and GMP principles for medical devices.
• Knowledge of SPC and root cause analysis.
• Familiar with product testing and inspection to meet specs.

Responsibilities

• Execute development, prototyping, testing, and documentation for new products.
• Support NPI projects from concept to commercialization with timelines and budgets.
• Collaborate with teams and suppliers to develop manufacturable processes.
• Plan process validation (IQ/OQ/PQ) and risk assessments per ISO 13485.
• Support QMS activities such as CAPA, PAR, and NCMR.

Education

Bachelor's or higher in Engineering (Mechanical/Biomedical) or related technical field

Job description

Working at Freudenberg: We will wow your world!

Responsibilities:

• 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.
• Support planning and executing NPI projects from concept to commercialization, ensuring timelines, budgets, and customer requirements are met.
• Collaborate with internal teams, customers, and suppliers to develop manufacturing processes, select materials, resolve technical issues, and support design for manufacturability.
• 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.
• 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.
• Contribute to feasibility studies and evaluate new technology identification to ensure scalable, compliant manufacturing solutions.
• 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.
• Support management of QMS activities such as CAPA's, PAR's, NCMR's and other applicable items as required.

Qualifications:

• Bachelor's/University degree in Engineering (Mechanical, Biomedical etc.) or related science/technical field.
• 3+ years’ experience in a medical device or related industry experience.
• Understanding of relevant ISO standards, knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements.
• Understanding of process validation principles and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols.
• Intermediate knowledge of quality control tools such as statistical process control (SPC) and root cause analysis.
• Familiarity with product testing and inspection methods to ensure compliance with specifications and standards.

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.