Post Market Process Analyst

Sunnyvale, California

Posted in Manufacturing and Production
about 1 month ago

This job has expired.

Job Info

At Intuitive, 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. Our mission is our guiding force; our culture is the DNA that makes us unique.  

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges. 

We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse 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 strive to 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 help to advance the world of minimally invasive care. 

Primary Function of Position:

The Post Market Process Analyst uses a strong firsthand knowledge of da Vinci® products, Intuitive processes, and regulations to work with technical and regulatory experts (internal and external), complaints analysts, R&D/Sustaining Engineering, RMA/FA/Post Market Investigation, dVStat, Service, Risk Management, the Data Analytic team, the commercial team, Clinical Engineering, Business IT, CSR and Customer Service support to assess existing and potential new process and customer satisfaction improvements within the Intuitive Surgical product lines. These products include instruments, accessories, robotic systems, vision systems, and other related products & features. The primary focus of this individual is to assess:

  • Opportunities to reduce process gaps and waste in the complaint handling process (focus on efficiency, accuracy while staying true to compliance)
  • Drive Kaizen and continuous improvement projects as a technical lead but also co-manage execution timeline with assigned Program Manager when needed
  • Work with EU-MDR, Aubonne, APAC, China JV and other Regulatory key stakeholders (US and OUS) to identify process hurdles and help enable process execution related to the complaint handling process, but also with data collection for regional post market planning and reporting (e.g. PMSP/ PSUR)

The ideal candidate possesses a solid technical/analytical background complimented by regulatory/compliance experience along with a natural curiosity to ask the right questions.  Further, they should be comfortable communicating nuanced technical and regulatory information across multiple levels of the organization. 

Roles & Responsibilities:

  • Engage broadly cross functional teams on behalf of the post market team to assist with the Kaizen and continuous improvement initiatives as needed.
  • Work alongside key stake holders to scope problem description
  • Lead detailed technical cross-functional discussions and execution on potential process and customer satisfaction opportunities
  • Analyze complaint related data to identify trends and patterns that may represent opportunities to reduce or eliminate specific customer issues.  Summarize and prioritize these findings in the form of recommended actions and projects showing anticipated benefits to customers and ISI. Review of complaint data to identify other data improvement opportunities.
  • Support New Product Introduction Activities in preparing the Complaints group in product knowledge,
  • Participate in necessary IT changes (e.g. TrackWise) to support product after launch.
  • Assist the team in planning, preparing and reviewing information to be presented at quality data review (QDR) weekly/monthly meetings, QRB/MR. 
  • Support audit activities associated with Post Market Surveillance processes

Skills, Experience, Education, & Training:

  • In order to adequately perform the responsibilities of this position the individual must:
  • Minimum Education/Experience: Bachelor or master’s degree in mechanical engineering, S.T.E.M. or other relevant engineering/technical discipline or minimum of 2-4 years of experience in a medical device compliance function with relevant exposure to direct complaint handling and customer interaction preferred
  • Proven ability to lead teams and work cross-functionally
  • Strong interpersonal, written and communication skills
  • Passionate about our mission to constantly make our products better
  • Able to think critically and assist people in finding creative solutions around constraints
  • Strong analytic skills as proven by track record for analyzing complex problems
  • Proven ability to navigate large datasets to extract essential themes and trends
  • Ability to deliver under pressure and tight deadlines
  • Knowledge of Good Documentation Practices & Quality Systems Regulations
  • Must be proficient in the use of Microsoft Office suite of applications.
  • Familiarity with Trackwise and SAP a plus.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.  

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. 

Shift : Shift 1 - Day

Travel : No

Travel Requirements: No Shift: Shift 1 - Day

This job has expired.

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