NPI Manufacturing Engineer

Job description

Job responsibilities

• Assist in developing and releasing manufacturing processes and EFTs for new accessories.
• Ensure processes meet quality standards. Manage and examine data for CPK and process capability, and implement improvements based on data.
• Conduct EFT qualifications to ensure readiness for production, validate equipment performance and reliability.
• Develop and validate test methods (TMV) to ensure product quality and compliance. Document and report validation results.
• Work closely with design engineers and clinical engineers to understand user needs and clinical requirements.
• Coordinate with quality and regulatory teams to ensure compliance with industry standards and regulations and support Supplier Engineering, Purchasing, Planning and Quality teams to resolve line facing issues.
• Resolve failures of varying complexity, of both process and hardware nature. Identify specific root cause and implement solutions to improve yield/manufacturability.
• Assist in product design reviews with a focus on DFX methods.

Job requirements

• Exceptional communication skills, both written and verbal. Necessary to engage with technicians, production management, product development, planning, purchasing, regulatory, inspection, customer support and clinical…
• A continuous improvement mindset
• Basic knowledge of process controls, including Six-Sigma, CPk, etc.
• Technical problem-solving skills with ability to identify root cause and drive corrective action (Fishbone, 8D Analysis)
• Able to travel periodically to suppliers or Intuitive manufacturing sites.
• Exceptional organizational skills and proven ability to work on fast-paced projects simultaneously .
• Excellent problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments
• Excellent technical skills in prototyping, tooling development, and troubleshooting