Sr. NPI Manufacturing Engineer

Job Type

Full-time

Description

We are looking for a highly skilled and motivated NPI (New Product Introduction) Engineer to join our dynamic team. The NPI Engineer will be instrumental in the successful introduction of new orthopedic products into our manufacturing processes. They will play a critical role in the development, scale up, and commercialization of new and existing product lines. This position requires a deep understanding of medical device manufacturing, design engineering principles, GD&T, new process development, project management, and cross-functional collaboration.

Requirements

Design Transfer:

• Collaborate with product development to review new product designs for manufacturability and recommend improvements.
• Support the transition of products from product development to manufacturing, ensuring a seamless scale-up process.
• Develop and introduce new manufacturing processes into full-scale production environments.
• Develop, document, and update work instructions and assembly procedures for production teams.
• Conduct process development (Experiments, DOE’s, etc.) and validation and qualification activities (IQ, OQ, PQ, MSA, etc.)
• Generate Bill of Operation and Bill of Material of material deliverables.
• Design and manufacture fixtures for new and established processes.
  
  

Cross Functional Collaboration

• Conduct feasibility studies and prototype builds to identify potential manufacturing issues early in the development process.
• Provide technical support and training to production teams regarding new product machining, finishing, laser marking, and assembly techniques.
• Collaborate with external suppliers and internal procurement teams to ensure timely delivery of materials and components at the prototype and production levels.
• Collaborate with quality assurance teams to ensure desired product quality is achieved.
  
  

Regulatory Compliance

• Ensure compliance with medical device quality standards and regulatory requirements
  
  

Risk Management And Continuous Improvement

• Conduct risk assessments through tools such as PFMEA and Engineering Testing and develop mitigation plans.
• Identify and resolve production issues and bottlenecks.
• Implement continuous improvement initiatives to enhance product quality, reduce cost, and increase efficiency.
  
  

Project Management And KPI’s

• Develop and manage timelines, project plans, and budgets for all design transfer initiatives, ensuring timely and cost-effective delivery.
• Track and report on key performance indicators (KPIs) to measure success and drive improvements in the design transfer process. KPIs include:
  
  

Team Leadership And Development

• Maintain up-to-date knowledge of industry trends and best practices.
• Participate and/or lead root cause analysis and problem-solving activities.
  
  

Qualifications

• A minimum of 7 years of experience in Medical Device or related industry preferably in orthopedic device manufacturing.
• A Bachelor's or Master's degree in Mechanical Engineering, Manufacturing Engineering, or a related field.
• Demonstrated Process Engineering experience, preferably in an NPI focused role.
• Experience with Swiss turning, Milling, and Finishing of Titanium, PEEK, and Stainless medical devices (Titanium Anodization, Sputter Coating, Deburring methods/automation, Cleaning, Passivation, Electropolish, etc.)
• Demonstrated experience in new process engineering, quality assurance, and quality control.
• Excellent communication skills and attention to detail.
• Ability to work under pressure in a fast-paced environment.
• Strong understanding of ISO 13485 with knowledge and experience in working with the Regulatory pathways associated with 510k approval process the associated ISO & ASTM standards
• Demonstrated fixture design experience, preferably in Solidworks.
• Ability to identify the best manufacturing methods for fixturing to ensure precision and longevity. Experience with additive and subtractive manufacturing methods is highly desirable.
• Six Sigma Green Belt and/or Lean Certification highly desirable.