Product Support Engineer – Quality Portfolio (Finance)

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
Primary Function of Position

The Product Support Engineer is responsible for providing operational and service engineering support of the Intuitive's Robotic System Platforms. The Product Support Engineer serves as a primary liaison between Intuitive's internal technical groups (Product Development and Product Operations) and the various internal and external departments within the Services Business (e.g. Field Service, Technical Product Education, Technical Support, Service Marketing). Primary focus of this Product Support Engineer will be supporting Field Service's Quality Portfolio, providing expertise in Field Service Process Design-Assurance, Service Design Control, Field Equipment Quality Management, Field Action Management, CAPAs and Audit Support.

Essential Job Duties

• Author and execute Verification and Validation Protocols and Reports for field service documentation, processes, equipment, tools, parts and software.
• Develop, manage, ensure compliance & calibration and field escalations related to field equipment/tools, field parts and service infrastructure/solutions.
• Provide technical support and service record management for Regulatory/Quality/Post-Market Surveillance activities (e.g. Field Actions, Non-conformance Events, CAPAs, Audits, Submissions)
• Lead service-related Design Control Process, Risk Management and Design History File development to define scalable and reliable standards and internal processes.
• Facilitate failure investigations, data collection and analysis, and work closely with product engineering, quality engineering & operations teams to identify product design, service and quality continuous improvement opportunities, initiatives and projects.

Qualifications
Required Skills and Experience

• Minimum 5 years of experience in Engineering Role or equivalent experience supporting Service or Quality organization required.
• Minimum 3 years of experience in the Medical Capital Equipment industry. Familiarity with medical device regulations, quality systems and standards (e.g. ISO 14971, ISO 13485, IEC 60601, and FDA Design Controls)
• Demonstrated experience reviewing and understanding complex electromechanical product/component specification to develop effective technical documentation and utilize effective analytical, troubleshooting and problem-solving skills.
• Demonstrated experience developing equipment qualification, calibration and PM procedures and practices.
• Demonstrated experience with design control and risk management from early design and development through commercialization.
• Demonstrated experience in identification and implementation of continuous improvement initiatives.
• Possess excellent written/oral/technical communication ability, with strong interpersonal skills and effective working in cross-functional and remote team environments.

Required Education and Training

• Bachelor's degree in Engineering discipline or equivalent experience required.

Preferred Skills and Experience

• Experience implementing the Lean/Six Sigma principles in both Engineering or Business environments. Lean Six Sigma Certification by an accredited body or equivalent desired.
• Familiarity with relational database management systems (e.g. SQL) and experience with statistical analysis tools.
• Experience with scripting languages (e.g. Python, Matlab, PowerShell etc.) and Atlassian toolset (e.g. JIRA, Confluence) a plus.
• Experience with Enterprise software and Electronic Documentation/Quality systems (Agile/ACCS, SAP, SalesForce, Polarion, Windchill, Trackwise)

Additional Information

Due 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.

Intuitive is an Equal 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.

Mandatory Notices

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

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 salary ranges are listed.

Base Salary Range Region 1: $125,500 USD - $180,700 USD
Base Salary Range Region 2: $106,700 USD - $153,500 USD
Shift: Day
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.