Engineering Manager, Product Label Implementation
Engineering Manager, Product Label Implementation
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Salary Not Disclosed
1 Vacancy
Job Description
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 Intuitives product lines including robotic systems instruments accessories endoscopes and FRUs (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:
- Lead 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.
- Lead mentor and grow a team of engineers to deliver above.
Qualifications :
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.
- Strong understanding of Good Manufacturing Practices (GMP)
- Strong understanding of analytical 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.
- Strong 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 Intuitives 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
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.
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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
