New Product Introduction Engineer II - Med Device

Freudenberg Group; Minnetonka (MN); On-site; USD 80,000 - 100,000; Full time

Job summary

Freudenberg Group is seeking a New Product Introduction Engineer II in Minnetonka, MN. The role involves developing, prototyping, and testing medical devices, ensuring compliance with regulatory standards and managing project timelines.

Applicants should have a Bachelor's degree in Engineering and over 3 years of relevant experience. The position offers a full-time contract with opportunities for growth in a dynamic environment.

Qualifications

• 3+ years’ experience in a medical device or related industry.
• Understanding of relevant ISO standards and GMP principles.
• Intermediate knowledge of quality control tools.

Responsibilities

• Execute development and prototyping of new products.
• Support NPI projects from concept to commercialization.
• Collaborate with teams to resolve technical issues.

Skills

3+ years in medical device industry

Understanding of relevant ISO standards

Intermediate knowledge of SPC

Familiarity with product testing methods

Education

Bachelor's degree in Engineering or related field

Job description

## New Product Introduction Engineer II - Med DeviceApplylocations: Minnetonka, MNtime type: Full timeposted on: Posted Todayjob requisition id: R\_00101507**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.