Senior NPI Engineer - Medical Devices & Prototyping

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

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.