Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.
Develops new packaging or containers to meet established requirements and maintains oversight and quality of existing packages/containers for all product groups. Defines package requirements for product groups and customer requirements. Develops recommendations according to the nature of the product, cost limitations, legal requirements, and the type of protection required, taking into consideration the need for resistance to external variables. May be responsible for coordination of activities and logistics at secondary contract packaging and labeling sites. Responsibilities may include documentation management and an understanding of good manufacturing practices (GMPs). Uses appropriate tools and performs integrity analysis of packaging.
Essential Duties & Responsibilities:
- Design, development and qualification of primary, secondary, and tertiary packaging solutions for existing and new Dexcom products.
- Lead validation & verification of packaging design, processes and equipment to support product extension to different geographies for commercially available packaging design.
- Implement changes to commercial packaging systems as necessary to support corporate objectives. This typically includes identifying requirements, gaining multi-department buy-in, communicating with vendors, updating documentation, and processing through document control system.
- Communication and collaboration with packaging vendors on new designs, tooling, and qualification. This includes, as necessary, identifying and onboarding new/secondary suppliers.
- Provide technical assistance in scaling up equipment and processes from prototype to pilot to full scale manufacturing.
- Develop and maintain technical project timelines and provide updates and feedback to project leadership.
- Provide technical oversight and coordinate Research and Development builds within a pilot production facility for multiple projects and project teams.
- Develop Packaging design requirement flow down.
- Identify project risks and track mitigations through standard methods.
- Exercise judgment within defined procedures and policies to determine appropriate action.
- This position assumes and performs other duties as assigned.
- Demonstrated ability to design, develop and implemented packaging system for sterile and non-sterile per ISO 11607-1/2, ASTM & EN standards.
- Exceptional technical writing skills through experience drafting study protocols and reports, validation protocols and reports, and technical analysis position papers.
- Proficiency with Medical Device development life cycles and packaging design, processes and technologies preferred.
- Demonstrated ability to run self-directed projects, maintain timelines, and execute projects in an R&D environment.
- Detail knowledge of selecting packaging material for sterile and non-sterile requiring ESD protection preferred.
- Experience in scaling-up from R&D design prototypes to fully automatable commercial packaging systems.
- Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
- Proven ability to work hands-on in a fast-paced environment.
- Detailed oriented with strong time management skills.
- Excellent communication (written and verbal) and personal interaction skills.
- Familiar with sterile barriers and various sterilization methods and design/process constraints.
- Self-starter who is able to formulate and execute a sub-project plan (including estimation of timeline and key milestones) with moderate technical guidance and managerial support.
- Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
- Comfortable in working cross-functionally with all internal departments, team members and outside suppliers.
- Strong communication skills with both internal and external contacts.
- Excellent attention to detail, especially technical writing.
- Proficient in the use of Esko ArtiosCAD and Cape Palletization Software SolidWorks or equivalent CAD software.
- Familiar with data analysis methods and analysis software, experience in JMP or Minitab preferred.
- Microsoft office applications (Project, Power Point, Visio, Excel, and Word) proficiency is required.
- Knowledge of Design for Six Sigma and/or Lean Six Sigma will be a plus.
Experience and Education Requirements:
- Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
- Up to 25%
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at email@example.com.
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.