Manufacturing Engineer - Process Development

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision stapling instruments for minimally invasive robotic surgery. The role requires active participation in the sustaining manufacturing engineering organization to refine mechanical components, assemblies, process documentation, tooling/fixtures/test tools, and test methods to improve efficacy, reliability, manufacturability, and cost for surgical robotic instruments.

Essential Job Duties

• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
• Provide production line support for day-to-day engineering issues on core instrument lines.
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
• Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability
• Take responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
• Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies, and field returns.
• Contribute to iterative component designs and manufacturing processes for reliability improvements and cost reductions.
• Create, maintain, and improve manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
• Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment.
• Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.

Qualifications

Required Skills and Experience

• Bachelors’ degree in Mechanical Engineering or related technical discipline.
• 2-5 years of experience as design or manufacturing engineer
• Experience in mid/high volume manufacturing of complex mechanisms including SPC knowledge.
• High mechanical aptitude.
• Experience in DFM assessment and BOM development.
• Strong oral and written communication skills.
• Experienced in ISO 13485 medical device manufacturing environment.
• CAD experience (SolidWorks)
• Sterilized medical device experience a plus.
• Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments, GR&R) in data analysis for process development and problem-solving.
• CAD experience (preferred Solidworks).
• Able to travel periodically to suppliers or Intuitive manufacturing sites.

Required Education and Training

• BS degree in Engineering discipline.
• MS degree in Engineering preferred.

Working Conditions

• None

Preferred Skills and Experience

• Prior experience designing automated equipment or complex mechanism manufacturing.
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment.
• Skills in problem solving and using MiniTab, Python, SQL, Tableau and/or oth