Sr. Packaging Engineer, Manufacturing Sciences

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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

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.

Essential Duties

Include, but are not limited to, the following:

• Packaging Design - Lead packaging strategy on projects, working with internal and external stakeholders to develop packaging designs, materials, and processes for new products.
• Packaging Testing - Apply expertise in testing, validation, packaging laws, industry-recognized standards and test methods (e.g., ASTM, ISTA, ISO, USP), regulations (e.g., ISO 11607, 21 CFR 820), and risk management to identify and recommend design improvements that address deficiencies.
• Process Improvement/Cost Reduction - 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.
• Packaging Documentation and Quality - 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.
• Leadership - 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.

Minimum Qualifications

• 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 ISO
  13485 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 Artios
  
  CAD, 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.

Preferred Qualifications

• 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.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and…