Job description

Position Title: PACKAGING ENGINEER 3

Location: SUNNYVALE, CA (onsite)

Role Type: Long term contract

Description

Primary Function Of Position
As part of the Packaging Engineering team, the person in this position will work to design and qualify packaging systems for instruments, accessories, endoscopes and system FRU’s across all ISI business units. The work will include designing, validating, and verifying packaging systems that include but not limited to, thermoform packaging such as Form, Fill & Seal trays, rigid trays and/or pouch sterile barrier systems, custom cartons, shippers, over shippers, reusable cases as well as identifying appropriate label stock for all products.

Roles and Responsibilities:

• Design and develop best in class packaging solutions from early concept through commercialization for sterile and non-sterile medical devices (includes Field Replaceable Units - FRU’s). Support packaging needs from concept through end of life.
• Design packaging solutions that meet both internal and external customer needs.
• Own of all aspects of design verification of the packaging systems to meet design requirements and release to production.
• Collaborate with manufacturing and process engineering to implement packaging designs compatible with class 100K clean-room environment.
• Identify new packaging processes to improve efficiencies and reduce cost.
• Develop component specifications, inspection plans and packaging protocols/reports to insure that the packaging system performs to requirements.
• Create and manage change requests within the document control system.
• Support qualification of sealing/packaging processes within clean room.
• Manage all projects to ensure that all internal and external packaging compliance requirements have been met and are not on the critical path for product launch.
• Set standards within the organization on what packaging requirements are needed for ISI products.
• As packaging SME, support audits, non-conformances and CAPAs as needed.

Skill/Job Requirements:

• BS Packaging Engineering, Mechanical Engineering, Industrial Engineering or applicable technical field.
• 5+ years of experience in medical device packaging design development and various packaging processes (high volume preferred).
• Thorough working knowledge of packaging dynamics, various packaging materials and their compatibility with sterilization processes such as, but not limited to EtO, and Gamma.
• Knowledge of packaging validation and verification requirements under CFR Part 820, ISO11607 part 1 & 2 and applicable ASTM standards. Strong understanding of GMP.
• Strong design and project management skills and to manage multiple re-usable and/or single use disposable (SUD) packaging projects across multiple product lines, on time.
• Strong verbal and written communication skills required to successfully collaborate with cross-functional teams and effectively communicate at multiple levels in the organization.
• Demonstrate a high level of service while managing a high and varied workload from internal clients and adhering to tight timelines.
• Self-motivated with an ability to prioritize and multitask effectively in a fast-paced, dynamic environment.
• CAD knowledge and experience (Pro-E or Solidworks) preferred.
• Must be able to travel occasionally to vendors, subcontractors and ISI Mexico plant

Thank you

Job Type: Contract

Pay: $65.00 - $72.00 per hour

Benefits:

• 401(k)
• Health insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift

Work setting:

• In-person

Education:

• Bachelor's (Preferred)

Experience:

• CAD OR Solidworks OR Pro-e: 5 years (Required)
• Packaging Engineering: 5 years (Required)
• ISO11607: 5 years (Required)

Work Location: One location

gatheringourvoice.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, gatheringourvoice.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, gatheringourvoice.org is the ideal place to find your next job.