Job DescriptionResponsible for leading and managing complex packaging engineering projects in medical device product development, production, and sustaining activities. Duties include creating, verifying, and maintaining packaging specifications; developing and validating sterile and non-sterile packaging systems; supporting packaging process improvements; and ensuring packaging designs, materials, and processes meet functional, regulatory, and quality requirements. Provide technical leadership, mentor engineering teams, and collaborate cross-functionally to resolve packaging and production issues and to continuously improve packaging systems and processes. Job duties:
- Lead and manage packaging development, improvement, and transfer projects for new and existing medical device products.
- Support sterile and non-sterile packaging systems for new products, product changes, line extensions, and sustaining engineering activities.
- Develop, review, and maintain packaging documentation including packaging specifications, Bill of Materials (BOM) drawings, test methods, and validation protocols.
- Contribute to design control deliverables for packaging design and process (e.g., DFMEA and PFMEA), design reviews, and change management processes.
- Draft, execute, and report packaging validations in accordance with ISO 11607, FDA, and internal Quality Management System requirements.
- Support audits and inspections of packaging processes (internal and external).
- Collaborate with Manufacturing, Quality, Regulatory, R&D, and Supply Chain to resolve packaging-related production and quality issues.
- Execute packaging validation and verification activities including packaging integrity, transportation simulation, and accelerated and real-time aging studies.
- Support new product introductions, product changes, and transfers by defining packaging strategies, validation plans, and timelines.
- Analyze data and implement improvements to ensure robust, repeatable, and compliant packaging processes.
- Confer with internal teams and external suppliers to evaluate packaging materials, components, and process changes.
- Support packaging transfer and supplier qualification activities across manufacturing sites.
- Investigate and resolve packaging-related nonconformances, deviations, and engineering changes using structured root-cause analysis tools.
- Drive continuous improvement initiatives, such as manufacturing automation, sustainability, integration of Unique Device Identification (UDI) or digital elements (e.g. RFID) and risk reductions.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
Qualifications- Bachelor of Science degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or related field.
- Minimum six (6) years of relevant work experience.
- Medical device experience.
- Strong written and verbal communication skills.
- Ability to lead cross-functional teams and manage internal and external relationships.
- Ability to design, execute, and analyze packaging validations and studies.
- Ability to read and prepare technical documentation including specifications, procedures, and drawings.
- Advanced computer skills including MS Word, Excel, PowerPoint, Outlook, and Teams.
- Experience with CAD tools (e.g., SolidWorks) for packaging and component design.
- Ability to work in a fast-paced, regulated manufacturing environment.
Desired Qualifications- Ability to apply lean and structured problem-solving methodologies to packaging projects.
- Comprehensive knowledge of medical device packaging materials, sterile barrier systems, and packaging equipment.
- Five (5) to seven (7) years of relevant packaging engineering experience.
- Expertise in packaging design, validation, and packaging process development.
- Statistical knowledge (DOE, Cpk) for packaging process characterization and optimization.
Physical- Extended periods of computer and/or microscope use.
- Extended periods of sitting or standing.
- Extended periods working in a cleanroom and/or manufacturing environment.
- Light lifting, up to 25 lbs.
- Domestic and international travel up to 25% as required.
- May be required within the position to be in an environment that can include radiation exposure (such as Cathlabs).
Salary Range$116,706 - $153,177 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)
