NPI Manufacturing Engineer

Intuitive•Sunnyvale, CA

3d•$87,500 - $139,200•Onsite

About The Position

Contribute your technical skills in the areas of manufacturing process technologies, process development, early engagement with NPD, problem-solving, training, and project management in a growing medical device company. In this key role, you will be the driving force behind next generation product and process development within Ion Accessories.

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 marketing organizations.
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.

Nice To Haves

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
Demonstrated ability to effectively design experiments, solve problems and implement them in manufacturing

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.
Create and revise work instructions for assembly and test processes, and train manufacturing team on new content.