New Product Introduction Engineer II - Med Device

Location: Minnetonka, Minnesota, United States

Company

hirify.global is part of the Freudenberg Group and focuses on medical device manufacturing.

What you will do

• Develop, prototype, test, and validate new products and manufacturing processes.
• Support new product introduction projects from concept through commercialization, including timelines, budgets, and customer requirements.
• Collaborate with internal teams, customers, and suppliers on materials, manufacturing processes, equipment qualification, and design for manufacturability.
• Plan and execute IQ, OQ, and PQ process validation, risk assessments, PFMEA, and process control strategies.
• Provide hands-on support for pilot builds, process development, production transfer, troubleshooting, and technical documentation.
• Support QMS activities, including CAPA, PAR, and NCMR processes.

Requirements

• Bachelor’s degree in engineering, biomedical engineering, mechanical engineering, a related science, or a technical field.
• At least 3 years of experience in the medical device or related industry.
• Knowledge of relevant ISO standards, GMP principles, medical device manufacturing, and country-specific regulatory requirements.
• Understanding of manufacturing process validation and safety protocols.
• Intermediate knowledge of statistical process control and root cause analysis.
• Familiarity with product testing and inspection methods used to verify compliance with specifications and standards.

Culture & Benefits

• Full-time employment with hirify.global.
• Equal opportunity workplace committed to diversity and inclusion.