Principal Packaging Engineer

Job Details: Principal Packaging Engineer Job Requisition Name: Principal Packaging Engineer Job Requisition No: VN8423 Work Location: USA - Waltham Worker Basis: Full Time Worker Type: Employee Contract Type: Permanent Applications Close Date: Jul 24, 2026 Purpose The Principal Packaging Engineer provides technical leadership and strategic oversight for packaging systems supporting medical devices from concept through commercialization and post‑market sustaining activities. This role leads high‑impact initiatives across new product development, regulatory programs (e.g., EU MDR), sustainability, and value improvement, ensuring packaging designs meet functional, regulatory, sterility, and supply‑chain requirements. The Principal Packaging Engineer serves as a subject‑matter expert in medical device packaging and a mentor to other engineers. Key Responsibilities Provide technical leadership and decision‑making authority for packaging systems across multiple product platforms. Serve as subject‑matter expert for medical device packaging, including sterile barrier systems, labeling, and distribution configurations, and maintain awareness of industry trends, standards updates, and emerging technologies relevant to medical device packaging. Lead packaging development activities from concept through commercialization in compliance with medical device design controls. Define project plans, timelines, scope, and deliverables for packaging‑related activities. Lead and support package integrity, transit, shelf‑life, and test‑method validation activities. Ensure compliance with applicable regulations and standards including ISO 11607, ASTMs, ISTAs, cGMPs, FDA, CE Mark, and EU MDR. Provide technical oversight for packaging changes related to sustaining engineering, quality improvement, cost reduction, and regulatory compliance, while assessing and mitigating risks related to sterilization, material compatibility, transportation, shelf life, and usability. Develop and approve packaging specifications, protocols, reports, and technical documentation. Partner with manufacturing sites and suppliers to ensure robust, scalable, and cost‑effective packaging solutions. Support packaging equipment selection, process capability studies, and process validation activities. Oversee prototype builds and testing with internal teams and external vendors. Manage multiple packaging initiatives across cross‑functional teams including R&D, Quality, Regulatory, Operations, and Supply Chain. Communicate technical status, risks, and mitigation strategies to stakeholders and leadership. Manage either directly or indirectly packaging engineers assisting the projects and providing technical expertise and mentorship. Qualifications Advanced knowledge of medical device packaging systems, materials, and test methodologies. Strong expertise in ISO 11607, ISTA, ASTM, and relevant international packaging standards. Proven ability to lead complex technical projects and cross‑functional teams. High engineering acumen, including design of experiments (DOE), risk analysis, and data‑driven decision making. Experience with sterilization modalities and their impact on packaging materials and systems. Excellent written and verbal communication skills. Ability to independently develop, execute, and document technical assessments, protocols, and reports. Strong organizational skills with the ability to manage multiple priorities simultaneously. Proficiency with Microsoft Office and project management tools (e.g., Microsoft Project, Smartsheets). CAD (SolidWorks) knowledge is a plus. Minimum Required Education and Experience Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related field. Minimum of 10 years of relevant experience in medical device packaging and/or product development within a regulated environment, or equivalent combination of education and experience. Demonstrated experience leading packaging development activities across the full product lifecycle from concept through commercialization. Experience operating in a regulated design controls environment required. #J-18808-Ljbffr