Job DescriptionPrimary Function of 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.
Essential Job Duties - 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.
Required Skills and Experience- 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
QualificationsRequired Education and Training - Minimum BS degree in Mechanical or Biomedical Engineering
Working Conditions Preferred Skills and Experience - 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
Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
