Sr. Packaging Engineer

Full Time
Pleasanton, CA
$82,100 - $164,100 a year
Posted
Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Qualifications

Minimum BS Packaging Engineering, Mechanical Engineering, Industrial Engineering, or applicable technical field. Minimum 4+ years of experience in medical device packaging design development and various packaging processes. Understanding 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, ISO 11607 part 1 & 2, applicable ASTM standards and global regulatory requirements. Experienced with IQ/OQ/PQ as part of packaging validation processes. Strong understanding of GMP and GDP practices. Strong design and project management skills and to manage multiple packaging projects across multiple product lines, on time CAD knowledge and experience (Solid works) preferred. Strong verbal and written communication skills required to successfully collaborate with cross-functional teams and effectively communicate at multiple levels in the organization Self-motivated with an ability to prioritize and multitask effectively in a fast-paced, dynamic environment. Ability to effectively work and communicate with vendors and suppliers.

Job Description:

Sr. Packaging Engineer will be the subject matter expert of sterile and non-sterile packaging and labeling materials, processes, design, testing and equipment’s. As part of the Packaging Engineering team, the person in this position will work to design and qualify packaging systems for instruments, accessories across Abbott HF division. The work will include designing, validating, and verifying packaging systems that include but not limited to, thermoform packaging, 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. This position will work closely with R&D, Marketing, Product Development teams, Regulatory affairs, Supply Chain, and Quality teams.

Roles and Responsibilities:

Design and develop packaging solutions from early concept through commercialization for sterile and non-sterile medical devices. Support packaging and labeling needs from concept through end of life. Own all aspects of design verification of the packaging systems to meet design requirements and release to production. Support labeling development and sustaining packaging and label related issues during production. Collaborate with manufacturing and process engineering to implement packaging designs compatible with clean-room environment. As packaging SME, support audits, non-conformances and CAPAs as needed Identify new packaging processes to improve efficiencies and reduce cost. Develop component specifications, inspection plans and packaging protocols/reports to ensure 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.

The salary for this role is between $82,100 – $164,100

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