Design Verification Engineer Labeling (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 Global Labeling group designs, develops, and supports product labeling for the full lifecycle of Intuitive's products. Our mission is to produce, optimize and sustain product labeling solutions through progressive improvements and curious discovery. This position is within the Technical Servies organization reporting to the Product Labeling & Packaging Operations Manager. The Design Verification Engineer (Labeling) will support project teams in developing, finalizing, executing, and implementing product label verification and its artifacts, while ensuring labels adhere to functional requirements, regional requirements, international standards, and cross-functional inputs from Marketing, Design Engineering, Regulatory Affairs, and Legal.
Roles and responsibilities
Essential duties
- Generate and take ownership of test protocol design, strategy, test execution, trace matrix, test report, artifacts, and related activities
- Perform all upstream and downstream requirements tracing using tools such as Polarion or equivalent
- Develop and execute test protocols for product labels
- Clearly document test results and observations in test reports
- Review and recommend improvements to test methods, leverage/incorporate industry best practices, collaborate with cross-functional partners and adhere to quality standards
- Identify and present problems that arise during feasibility and design verification testing, and escalate new or persistent failure modes to appropriate engineering teams
- Proactively engage with engineering teams on failure investigation and root cause analysis
- Passionate about achieving first-time-right results
Other responsibilities:
- Manage and qualify all lab test equipment
- Perform a broad variety of tasks in support of label verification and process design established by departmental goals
- Deep understanding of design controls processes related to verification and validation
- Perform equipment validation as required (IQ/OQ/PQ)
- Ensure successful, on-time completion of department projects; communicate constraints to direct management when successful project completion is at risk
- Own label verification deliverables for assigned projects as the Subject Matter Expert (SME)
- Actively contribute to core team meetings by providing insights, and updates on project deliverables, ensuring alignment with overall project goals
- Collaborate closely with Packaging and Test Engineering teams to drive seamless integration, troubleshoot issues, and ensure compliance with quality and performance standards
Education and experience
- Minimum of bachelor's degree in engineering, or a related field
- Minimum of 4 years of experience working in labeling, hardware, system production, or test environment primarily as Verification Engineer in the medical device industry
Technical skills
- Working knowledge of tools for label development such as Robar, Prisym360, Bartender, PLM (Agile), issue tracking (Jira), and software testing (Qtest) is preferred.
- Experience with Polarion or other equivalent requirements tracing software is a plus
- Experience working in a regulated industry is preferred. Proven understanding of medical device standards including ISO, FDA, GDP, and GMP guidelines is preferred.
- Prior experience with labeling equipment, such as thermal transfer printers, Form-Fill-Seal (FFS) systems, and UV laser markers is a plus
- Comfortable making risk-based conclusions, interpreting regulations, and explaining and justifying strategies based on quality systems
Other skills and abilities
- Able to learn and apply established procedures in a reliable and consistent manner
- Proven leadership, negotiation, interpersonal, communication, and facilitation skills
- Ability to manage and deliver in a matrix organization environment
- Excellent written and verbal communication skills with the ability to work effectively across departments and influence stakeholders
- Exceptional problem-solving skills and ability to be self-managed in a fast-paced environment utilizing agile/sprint methodologies
- Quick learner with the ability to understand complex products and processes
- Ability to work in a team environment
- High level of attention to technical details and accuracy
- Ability to work unsupervised and with minimal supervision
- Ability to multitask, and handle tasks with contesting priorities effectively
- Proficient with MS Office applications, including Word, Excel, Outlook, and Teams
Integrity
- Accept and adhere to high ethical, moral, and personal values in judgments, communications, actions, and when dealing with others
Travel
- Role is onsite 4 days/week based in Sunnyvale, California. Ability to travel (10%) domestically and internationally as needed to support programs at other facilities
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 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.
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.
Base Salary Range Region 1: $127,800 USD - $184,000 USD
Base Salary Range Region 2: $108,700 USD - $156,400 USD
Shift: Day
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
