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The Senior Packaging Engineer, Manufacturing Sciences role will lead design and development of packaging for commercialization of new Exact Sciences’ products through the design transfer process, as well as manage changes to existing products. This role will be responsible for creating and maintaining the packaging design and packaging validation programs, utilized across Exact Sciences locations, compliant with packaging laws, industry-recognized standards and test methods (ASTM, ISTA, ISO, USP, etc.). This role will support implementation of existing and novel packaging test methods, as well as establish requirements and specifications to ensure product effectiveness and customer satisfaction.
Job Responsibility:
Lead packaging strategy on projects, working with internal and external stakeholders to develop packaging designs, materials, and processes for new products
Apply expertise in testing, validation, packaging laws, industry-recognized standards and test methods, regulations, and risk management to identify and recommend design improvements that address deficiencies
Drive improvements across product lines and contribute to cross-site efficiency or cost-reduction initiatives
Monitor available technologies in packaging materials and processes to identify and implement opportunities for improvement
Work with vendors and outside resources in the continuous improvement of packaging materials and processes
Ensure quality and compliance of all packaging materials through specifications, validation, and root cause analysis
Author and improve Quality System documentation and lead corrective actions, change control, and risk mitigation in collaboration with Quality Engineering
Mentor junior engineers and provide technical guidance
Lead packaging phases of projects
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
Support and comply with the company’s Quality Management System policies and procedures
Maintain regular and reliable attendance
Requirements:
Bachelor’s degree in Packaging Engineering or a relevant field as outlined in the essential duties. Bachelor's degree in Engineering, Logistics, or Supply Chain will be accepted provided a certificate in packaging engineering has been obtained
5 years of experience in packaging design and/or packaging manufacturing within FDA regulated and/or ISO13485 environments
2 years of experience in injection molding or thermoforming processes for primary containers and/or packaging materials
2 years of experience working within SAP or other ERP systems
Experience with CAD tools such as ArtiosCAD, Solidworks, or equivalent
Demonstrated ability to perform the essential duties of the position with or without accommodation
Authorization to work in the United States without sponsorship
Nice to have:
2 years of experience designing and implementing packaging solutions for medical devices compliant with international and dangerous goods standards
Experience leading validation efforts, including protocol development and approval of IQ/OQ/PQ reports
Experience leading packaging-focused sustainability initiatives
What we offer:
Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
Retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage