Senior Staff Engineer Jobs in Natick, MA

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.
• Own design transfer activities to external manufacturing partners for both new products and product changes. Activities could include, but not limited to: Cost analysis, process and equipment development, supplier capability development, control of Manufacturing and Quality documentation.
• Lead the Change Control process for product or process improvement projects.
• Create design transfer plans, schedules, and deliverables. Document project activities.
• Work closely with suppliers, purchasing and development to ensure design specifications 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.
• Develop DFM best-practices and guidelines.
• Assist in 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

• May contribute directly to new product engineering or product design changes depending on resource availability.
• Review product designs for manufacturability content.
• Develop Quality Management System procedures to refine the New Product Introduction/Design Transfer process.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• Bachelor of Science in Manufacturing, Mechanical or Electrical Engineering or equivalent experience.
• Five or more years in related work experience in a medical device environment.
• Understanding of elements 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 of durable medical 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 is a plus.
• Able to prioritize and take initiative with minimal guidance.
• Able to help facilitate actions and work with others across multiple departments and organizations.
• Strong problem-solving skills.
• Self-motivated.
• Ability to work effectively to 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.