Design Verification Engineer Labeling

Primary function of position

The Global Labeling group designs develops and supports product labeling for the full lifecycle of Intuitives 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 crossfunctional inputs from Marketing Design Engineering Regulatory Affairs and Legal.

Roles and responsibilities

• 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 crossfunctional 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 firsttimeright 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 ontime 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)
  • Closely 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

Qualifications :

Education experience skills and training

Education and experience

• Minimum of bachelors 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 FormFillSeal (FFS) systems and UV laser markers is a plus
• Comfortable making riskbased recommendations 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 lead and deliver in a matrix organization environment
• Excellent written and verbal communication skills with the ability to work effectively across departments and influence stakeholders
• Proven problemsolving skills and ability to be selfmanaged in a fastpaced 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 independently and with minimal supervision
• Ability to multitask and handle tasks with competing 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 decisions 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

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 COVID19. 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 marketcompetitive 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 COVID19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity / Affirmative Action 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.

EEO and AA Policy

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 marketcompetitive 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.

Remote Work :

No

Employment Type :

Fulltime