Intuvie

GENERAL SUMMARY

The New Product Introduction (NPI) Engineer at Intuvie facilitates the transition of new products and product changes from the engineering team to the manufacturing team. Successful candidates possess a blend of technical and hands-on experience in medical device development and manufacturing. Experience with the detailed requirements of CGMP, familiarity with general product quality management, and manufacturing engineering and process development are important for this role. The NPI Engineer will be a key member of the engineering team, ensuring DFM during development while being responsible for technology transfer activities with internal teams and external manufacturing partners to transition products from development to full scale production. The job responsibilities are broad and require flexibility, attention to detail, and good organization skills.

ESSENTIAL JOB FUNCTIONS

• Work with Engineering, Quality, and External Manufacturing teams to provide guidance on manufacturability, robustness, DFM, and process/supplier development during new product development and post market/sustaining support.
• Owndesign transfer activities to external manufacturing partnersfor both new productsand product changes. Activities could include, but not limited to: Cost analysis, processand equipment development,suppliercapabilitydevelopment, control of Manufacturing and Quality documentation.
• Leadthe Change Control process forproduct or process improvement projects.
• Create design transfer plans,schedules, and deliverables. Document project activities.
• Work closely with suppliers,purchasingand development to ensure designspecifications are adequately defined and met.
• Analyze and improve the effectiveness of current contract manufacturing processes.
• Analyze and improve the efficiency and quality of manufactured parts and sub-assemblies.
• Develop efficient process flow, manufacturing fixtures, and manufacturing work instructions in collaboration with contract manufacturers.

• DevelopDFMbest-practicesand guidelines.
• Assistin evaluating, resolving, and auditing quality issues.
• Provide guidance for Lean Manufacturing at Contract Manufacturer to reduce waste
• Initiate continuous improvement projects throughout the company.
• Oversee and Support Contract Manufacturer for the selection, installation, qualification (IQ/PQ/OQ) of tooling and/or capital equipment utilized in product manufacture.
• Provide progress reports to management as required.

OTHER DUTIES AND RESPONSIBILITIES

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• Bachelor of Science inManufacturing, Mechanical or ElectricalEngineering or equivalentexperience.
• Five or more yearsinrelated work experience in a medical device environment
• Understanding ofelements of design that impact product cost and quality. Ability to influence the cost and quality of new products early in the design process.
• Experience with the full development life cycle ofdurablemedical equipment and disposables.
• General understanding of all manufacturing operations within the company and at our contract manufacturers and their suppliers
• Excellent analytical, organizational, written, verbal communication, and hands-on skills.
• Works cooperatively with R&D, Quality and Regulatory, Production Facilities, Supply Chain, and Marketing on complex projects to ensure project success
• Proficient in Computer Aided Design software such as SolidWorks
• Experience with statistical methods. Six-Sigma Green Belt isa plus.
• Able to prioritize and take initiative with minimal guidance
• Able to helpfacilitateactions and work with others across multiple departments and organizations
• Strong problem-solving skills
• Self-motivated
• Ability to work effectivelyto meet deadlines
• Solid organizational skills-able to handle multiple tasks simultaneously
• Working knowledge of Microsoft applications including MS Project
• Fluency in Mandarin is a plus