NPI Engineer

The NPI (New Product Introduction) Engineer is responsible for managing and overseeing the process of introducing new products into manufacturing, bridging the gap between product design and full production. This role ensures product designs are manufacturable, develops and tests production processes, and troubleshoots issues from prototype through launch. The NPI Engineer coordinates with design, sales, engineering, quality, and manufacturing teams to ensure smooth product launches. The ideal candidate has a strong background in medical device development, a working knowledge of ISO 13485 and Design Controls, and familiarity with plastic materials and processes.

KEY RESPONSIBILITIES

• Champion and uphold the company's values, mission, and quality policy in all activities.

• Adhere to and help enforce company policies, procedures, and internal control standards.

• Ensure compliance with all applicable Quality Management System (QMS) requirements, including ISO 9001, AS9100, and ISO 13485, as applicable to this role.

• Follow all safety rules and PPE requirements, and promptly report hazards, incidents, and near-misses.

• Work closely with the design team to ensure new products are designed for manufacturability, cost-effectiveness, and efficiency.

• Evaluate product technical requirements and help define technical specifications.

• Help create prototypes, identify potential design or production issues, and test different manufacturing methods.

• Develop and optimize manufacturing processes that meet quality standards and can be scaled for production.

• Coordinate testing of the product and production processes to verify that the product performs as intended and is built to specification.

• Oversee the product lifecycle from development to launch, collaborating with design, operations, quality, and logistics to ensure smooth transitions between phases.

• Address issues that arise during the transition from prototype to production, including supply chain or assembly challenges.

• Create and maintain documentation of processes, designs, technical specifications, and testing results, and provide regular updates to senior management.

• Support development phases guided by Design Controls requirements and comply with Quality SOPs.

• Apply a strong understanding of ISO 13485 to participate in audits and guide coworkers.

• Independently work through complex problems with some input from senior colleagues.

• Perform other related duties as assigned.

EDUCATION & EXPERIENCE

• Bachelor's degree in Engineering (Mechanical or Manufacturing preferred) required.

• 5+ years of related experience in a manufacturing environment required.

• 5–10 years of experience in the medical device design and development field.

• Foundational SolidWorks skills.

SKILLS & QUALIFICATIONS

• Functional technical and clinical understanding of products being actively worked on, with a developing breadth of technical process expertise.

• Familiarity with plastic materials and processes.

• Strong understanding of ISO 13485 and Design Controls; working knowledge of ISO 9001 and AS9100, as applicable to this role.

• Proficiency with Microsoft Office Suite (Teams, Excel, PowerPoint, Outlook).

WORK ENVIRONMENT

• Office setting.

• Manufacturing floor environment.

• Use of personal protective equipment (PPE) such as safety glasses.

PHYSICAL REQUIREMENTS

• Prolonged periods sitting at a desk and working on a computer.

• Mobility to navigate the production floor to support prototype builds, testing, and troubleshooting.

EXPECTED HOURS OF WORK

• This is a full-time exempt position, required to work Monday through Friday. Occasional weekend availability may be required based on business needs.

TRAVEL

• Up to 20% international travel required.