We are looking for NPI/Sustain Mechanical Engineer! Job description: The NPI/Sustain Mechanical Engineer is responsible for supporting new product introduction (NPI) from design through production, ensuring manufacturability, quality, and cost targets are met. The role includes sustaining engineering activities such as troubleshooting field issues, implementing design improvements, and supporting continuous product optimization. The engineer works cross-functionally with R&D, manufacturing, quality, and suppliers to resolve technical challenges and drive product readiness. Develop and maintain documentation, including drawings, TEST protocols, and validation reports.
Responsibilities:
Collaborate with the design engineering team to review and improve mechanical designs for manufacturability and cost-effectiveness.
Support the development of prototypes and testing of new designs. Plan, design, and perform prototype builds, including tests for functionality, durability, and reliability.
Ensure product designs are optimized for manufacturing.
Support production lines across multiple contract manufacturers, implement design improvements, and drive continuous product optimization.
Work with suppliers and manufacturers to ensure they understand the design and meet required specifications.
Identify and resolve mechanical design issues and challenges during the transition from prototype to production.
Prepare and maintain comprehensive product documentation, including technical drawings for tools, specifications and manufacturing instructions.
Conduct process validation IQ, OQ, and PQ activities to ensure that all systems and processes meet regulatory standards and deliver products of the highest quality.
Requirements: Required Experience:
3-5 years of experience in new product introduction, product development, or manufacturing engineering, preferably in the medical device industry.
Hands-on experience with SolidWorks for mechanical design.
Familiarity with product lifecycle management (PLM) tools and processes.
Strong understanding of materials, manufacturing processes, and product testing methodologies.
Proficiency in root cause analysis and solving complex mechanical problems.
Excellent communication skills, both written and verbal.
Ability to work effectively in cross-functional teams and manage multiple projects simultaneously.
This position is open to all candidates.