Sr. Packaging Engineer

Job 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. They will provide the leadership, and aid in technical development of junior members in the team.

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.

Qualifications

Skill/Job Requirements:

• Minimum BS Packaging Engineering, Mechanical Engineering, Industrial Engineering or applicable technical field.
• Minimum 12 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

Additional Information

All your information will be kept confidential according to EEO guidelines.

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 Employment 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.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.