Engineering Manager, Product Label Implementation

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.

Primary Function of Position:

As part of Process Engineering team, the product labeling implementation manager will work to design and build a team and system for a common implementation of product labels across all of Intuitive’s product lines, including robotic systems, instruments, accessories, endoscopes and FRU’s (Field Replaceable Units). They will provide the leadership to build a team to establish best-practice standards for hardware, documentation, validation and implementation of labels with the accuracy required of a world-leading medical device manufacturer. The work will cover a variety of labeling systems and media such as in-line and purchased paper-based label printing, direct marking (e.g., laser marking), thermoform packaging with sterile barriers and custom cartons. Comprehensive knowledge and support of end-to-end labeling and packaging processes, equipment, and business systems will be used to establish, sustain, and continuously improve manufacturing and operations activities.

Roles & Responsibilities:

• Drive the interface between the label design and process engineering teams to ensure successful and standardized implementation of product labels in volume production.
• Provide input to the label design team to develop best-in-class product labeling and packaging solutions from early concept through commercialization for sterile and non-sterile medical devices.
• Use expertise with enterprise-scale business systems (e.g., SAP, Agile), manufacturing best-practices, and equipment to identify opportunities and improve work methods.
• Support product labeling and packaging needs from concept through end of life.
• Manage all projects to ensure internal and external compliance requirements have been met and are not on the critical path for product launch.
• Own all aspects of label implementation to meet design requirements and production release.
• Build a system of standards for hardware, software, documentation, validation and production implementation to achieve a standard workflow for label design changes.
• Drive, mentor, and grow a team of engineers to deliver above.

Skills, Experience, Education, & Training:

• Minimum BS in Packaging Engineering, Mechanical Engineering, Industrial Engineering or applicable technical field.
• 8+ years of experience in medical device or life sciences manufacturing, preferably in packaging or labeling (high volume preferred).
• 3+ years managing an engineering team
• Thorough knowledge of process design, qualification and production implementation, from initial concept through sustaining production.
• Proven understanding of Good Manufacturing Practices (GMP)
• Proven understanding of data-backed and statistical techniques commonly used in manufacturing, including (p)FMEA, tolerance analysis, design of experiments, statistical process control, gauge reliability and repeatability, etc.
• Proven design and project management skills to manage multiple projects across multiple product lines, on time.
• Proven verbal and written communication skills required to successfully collaborate with cross-functional teams and effectively communicate up and down within the organization.
• Ability to function as a ‘working manager’ to deliver projects concurrently while building a team and workflow standards.
• Self-motivated with an ability to prioritize and multitask effectively in a fast-paced, dynamic environment.
• CAD knowledge and experience (Solidworks) preferred.
• Must be able to travel occasionally to vendors, subcontractors and Intuitive’s international facilities.

Working Conditions:

• Must be available to work full-time in Sunnyvale, CA
• Up to 25% travel. Some international travel may be required.

Preferred Skills and Experience

• Experience duplicating production facilities to new sites; line transfers
• Medical device process qualification: DQ/IQ/OQ/PQ
• Creation, use and governance of manufacturing equipment design and construction standards

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.

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.

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.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

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.