Packaging Engineer II

Essential Responsibilities:

- Collaborate with cross-functional teams, including Marketing, Product Development, Quality, and Regulatory to define, develop, and finalize reusable packaging specifications in compliance with regulatory and quality requirements.
- Design and develop reusable packaging (Metal trays, Mesh baskets, Inner trays and Lids) solutions by establishing instrument layout configurations aligned with packaging, usability, cleaning and sterilization requirements.
- Execute distribution simulation testing and perform fit checks to ensure packaging performance, proper configuration, and compliance with quality standards.
- Coordinate with suppliers to support development, validation and readiness of reusable packaging solutions, ensuring alignment with project timelines and deliverables.
- Develop packaging test protocols and prepare test reports; perform perforation assessments to verify sterilant penetration and document no-test rationale where applicable.
- Packaging costing experience, including cost analysis and optimization.
- Identify and execute cost-saving initiatives related to packaging design, materials, and processes while maintaining compliance with quality and regulatory standards.
- Drive project management activities, including planning, tracking, coordinating cross-functional deliverables, leading reviews and ensuring alignment with timelines and milestones.
- Serve as the primary point of contact across internal teams and suppliers, facilitating communication, resolving risks/issues, and ensuring smooth execution and decision-making.
- Engage and collaborate with multiple suppliers to develop and implement packaging solutions, ensuring compliance with quality standards and project timelines.

Must-Have:

- Bachelor’s degree in Packaging Engineering or Biomedical Engineering (or a related field) with 4-7 years of relevant experience, or a Master’s degree with a minimum of 4 years of relevant experience.
- Proven experience managing at least two end-to-end packaging projects from concept through validation and implementation.
- Proficiency in Microsoft Project or equivalent project management tools.
- Experience working with Agile PLM systems for managing product lifecycle data, documentation, ECOs, and change processes.




- Robust working knowledge of ASTM standards in alignment with ISO 11607‑1 and ISO 11607‑2 for packaging validation and compliance
- Hands-on experience in performing runout testing and other relevant validation activities to ensure packaging and instrument performance meets quality requirements.
- Experience identifying and implementing cost optimization opportunities in packaging design while maintaining compliance.
- Hands-on experience in sterile reusable packaging systems and associated regulatory requirements. Strong understanding of ISO 15883 (cleaning validation) and ISO 17665 (steam
- sterilization). Experience with labeling requirements per ISO 15223.
- Hands-on experience with EU-MDR compliance, including Technical File
- remediation and gap assessments.
- Proficiency in CREO or SOLIDWORKS for design and development support.

Desired Qualifications:

- Experience in sterile packaging systems (Rigid/Flexible)
- Familiarity with SAP process flows, including procurement, costing and material management workflows.
- Ability to identify and implement cost optimization initiatives in packaging design and processes.
- Familiarity with e‑IFU processes and regulatory expectations for electronic labelling
- Experience with EU‑MDR remediation activities, including Technical File updates, gap assessments, and compliance alignment.
- Experience with sustainability initiatives, including material reduction, recyclability, and environmental compliance.

Responsibilities may include the following and other duties may be assigned. Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.



Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques.

Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals.

The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

📌 Packaging Engineer (Hyderabad)
🏢 HealthMinds Consulting
📍 Hyderabad