Job description

Packaging Engineer
Sunnyvale,CA (100% onsite role)
12 Months

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 plan

Job Type: Contract

Salary: $60.00 - $65.00 per hour

Experience level:

• 5 years

Schedule:

• 5x8
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• Sunnyvale, CA: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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