Senior Sterile Packaging Engineer

Job Description

Job Description

ABOUT US: Red Star is a vertically integrated U.S.-based contract manufacturer specializing in injection molding, precision machining, cleanroom assembly, and sterile packaging for the medical device industry. From concept through high-volume production, our teams work together to solve complex manufacturing challenges and help bring innovative medical devices to market.

SUMMARY: The Senior Sterile Packaging Engineer serves as the technical lead and subject matter expert for sterile packaging activities. This role partners cross-functionally with Regulatory, Product Development, Operations, Supply Chain, and Quality to develop and execute sterile packaging strategies from concept through commercialization and post-market support. The Senior Sterile Packaging Engineer ensures sterile packaged products meet requirements for sterility assurance, packaging integrity, shelf life, transportation, distribution, and regulatory compliance.

This position provides technical leadership for packaging design and development, validation strategy, process controls, and technical documentation, including Design History File (DHF) requirements. While this role has no direct supervisory responsibility, it mentors engineers and technical staff, leads cross-functional packaging projects, and helps establish best practices related to sterile packaging, sterilization, and continuous improvement.

ESSENTIAL DUTIES AND RESPONSIBILITIES: ( includes the following but other duties may be assigned)

• Lead the design, development, implementation, and lifecycle support of sterile packaging systems across product lines in partnership with Product Development teams to ensure packaging, labeling, and sterilization requirements are achieved.
• Serve as the technical lead for sterile packaging activities supporting new product introductions, design changes, and sustaining engineering initiatives.
• Design, evaluate, and approve packaging components and sterile packaging systems for medical device products.
• Develop, review, approve, and maintain packaging, labeling, and related technical documentation to ensure compliance with applicable requirements.
• Lead or facilitate risk assessments related to product, packaging, sterilization, and process changes to maintain sterility assurance and package integrity.
• Develop validation strategies and execute sterile packaging validation and verification activities, including sealing validations, IQ/OQ/PQ, design of experiments, transit testing, aging studies, and ongoing process monitoring.
• Monitor, evaluate, and improve sterile packaging processes across internal and external manufacturing locations.
• Develop and maintain procedures, work instructions, technical standards, and training materials related to sterile packaging and sterilization activities.
• Prepare and provide technical oversight for protocols, reports, technical justifications, and validation documentation.
• Ensure sterile packaging validation programs remain current, effective, and compliant with customer, regulatory, and internal quality requirements.
• Support design transfer activities by defining, documenting, and optimizing critical process parameters based on process capability and risk.
• Partner with Operations to optimize sterile packaging equipment, manufacturing processes, and production readiness while providing technical consultation to customers and contract manufacturing partners.
• Lead sterile packaging projects by coordinating technical activities, priorities, and deliverables to support business objectives and product launch commitments.
• Lead or support investigations and corrective actions associated with post-market surveillance, nonconformances, and quality events related to sterile packaging.
• Represent the sterile packaging function during customer, internal, regulatory, and certification audits.
• Provide technical mentoring, coaching, and knowledge sharing to engineers and other team members, while supporting the development of cross-functional project teams.

QUALIFICATION REQUIREMENTS:

• Bachelor's degree in Packaging Engineering, Packaging Science, Engineering, or a related technical discipline.
• 3-5 years of experience in sterile packaging within the medical device, pharmaceutical, or other regulated industry; medical device experience strongly preferred.
• Demonstrated experience leading technical projects and collaborating across cross-functional teams.
• Experience with sterile packaging validation, design controls, and regulated product development preferred.

OTHER SKILLS and ABILITIES:

• Strong technical expertise in sterile packaging design, validation, and regulatory compliance.
• Knowledge of applicable standards including ISO 11607, ISO 11137, relevant ASTM standards, and quality system requirements.
• Experience with manufacturing processes, process validation, statistical analysis, and risk management methodologies.
• Ability to influence decision-making and drive execution across multiple stakeholders and facilities.

BENEFITS:

• Health, dental, and vision insurance
• Paid time off and paid holidays
• 401(k) with company match
• Bonus opportunities

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

While performing the duties of this job, the employee is regularly required to sit, talk, and hear. The employee is frequently required to stand, walk, and use hands to handle or feel objects, tools, or controls. The employee may occasionally be required to reach with hands and arms and lift and/or move up to 20 pounds.

The employee will typically work in a manufacturing environment and may be exposed to high noise levels from machinery, moving machine parts, and other physical hazards. The physical demands and work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.