Senior Engineer, Packaging

About the role

Provide technical leadership and engineering support for the design, development, validation, implementation, and continuous improvement of released medical device packaging systems and processes. Serve as the packaging subject matter expert, driving process development, cost-reduction initiatives, and operational improvements through packaging design optimization, material selection, and manufacturing efficiency enhancements. Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Operations, Supply Chain, Regulatory Affairs, and suppliers to develop, validate, and sustain compliant, scalable packaging solutions. Support new product introductions, process validations, testing activities, and sustaining engineering efforts while identifying opportunities to improve quality, reliability, throughput, and overall business performance.

Responsibilities

• Plans and executes key package engineering assignments related to operations, manufacturing, and sustaining activities.
• Engages in and leads packaging projects related to process development, cost saving initiatives, innovative package design, equipment standardization, and test method development.
• Determines and coordinates performance and stability testing to ensure product and package integrity for design and manufacturing through the end-user.
• Leads troubleshooting efforts for the resolution of packaging related issues for design, manufacturing, and in the field.
• Drives packaging improvements for design, processing, and functional requirements and leads the implementation activities.
• Executes packaging projects and support in compliance with government and corporate guidelines.
• Supports risk assessment and compliance assurance programs for packaging.
• Creation of packaging design requirements; such as component prints, assembly prints, and inspection criteria.
• Create, review, and approve internal packaging verification and validation documentation.
• Lead continuous improvement measures by providing technical information and reviewing packaging designs and processes as they are revised.
• Train operators, supervisors and other employees on use of new packaging designs, testing, equipment and/or processes.
• Train operators, supervisors and other employees on use of new packaging designs, testing, equipment and/or processes.

Qualifications

• Bachelor of Science degree in science, engineering or technology discipline.
• Minimum of 5 years of professional experience within the medical device industry supporting packaging is required.
• The ideal candidate should have a successful record of supporting packaging design and process development across an organization.
• Experience working in integrated cross-functional product development teams.
• Experience developing packaging for new product development.
• In-depth knowledge of ISO 11607-1/2 and how it guides requirements for packaging design, process development, manufacturing, and testing.
• Knowledge of sterile packaging design, material characteristics, and verification/validation practices.
• Must be able to support multiple project teams simultaneously, as well as lead packaging specific projects when needed.
• Demonstrated experience in executing design verification and/or process validation of packaging in the medical device industry; including technical writing of protocols and reports.
• Experience in writing and executing design verifications and/or process validations is required.
• Knowledge of and understanding of ISO13485 and its application to medical device products.
• Experience in supplier selection/management for medical device packaging materials and equipment.
• Understanding of risk analysis and experience in the creation of design and process FMEAs.
• Capable of developing packaging processes including all elements of process validation.
• Proficient with the use of Microsoft Office applications.
• Time management skills allowing for leading or working on multiple projects at once.

Preferred

• A packaging engineering degree is preferred.
• Process development and/or manufacturing experience preferred.
• Practical application of statistical analysis and techniques, as well as Design of Experiments (DOE), is preferred.

Benefits

Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive medical, dental, vision coverage effective on start date
Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**
Paid volunteering and charitable donation/match programs
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance