New Product Introduction Engineer II - Med Device

New Product Introduction Engineer II - Med Device

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

• 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.
• Engage in cross-functional communication and external collaboration to align project goals, manage stakeholders, to facilitate NPI project timelines.
• 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.

Benefits

• 401K Match: Save for retirement with the company's help.
• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.
• Safety Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.
• Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.

Pay

The expected salary range for this position is $90,000 to $105,000 annually, depending on skills, experience, and qualifications.

Schedule

On-Site Freudenberg Medical LLC payments

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.