Engineer I, Product Sustaining - Defined Term

Getinge•Wayne, NJ

2d•Onsite

About The Position

This position delivers engineering solutions supporting released sterile packaged consumable medical devices with primary focus on packaging systems, sterile barrier performance, and product labeling lifecycle support. Approximately 70% of responsibilities are focused on labeling and packaging engineering execution, including packaging validation, labeling implementation, specification development and maintenance, and packaging performance testing. Approximately 30% of responsibilities support sustaining engineering activities, including second supplier qualification, supporting current design specifications, and maintaining and updating released product specifications. The role works cross-functionally with Packaging Engineering, Sustaining Engineering, Quality, Regulatory, Operations, and Supply Chain to ensure compliant, robust, and cost-effective product packaging and labeling systems.

Requirements

Bachelor’s Degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related technical field, or equivalent experience.
0-2 years experience in medical device or regulated manufacturing environment preferred.
Willingness to learn new concepts and execute actions to complete tasks on time.
Basic knowledge of: Design Controls, GMP / 21 CFR Part 820, Packaging validation concepts (ISO 11607 exposure preferred).
Basic understanding of sterile packaging systems and sterile barrier concepts.
Basic understanding of labeling control, specification management, and documentation systems.
Ability to execute engineering protocols and document results in a clear and compliant manner.
Strong technical documentation and specification management skills.
Ability to perform measurement, data analysis, and technical evaluation to support troubleshooting, investigation, and engineering problem-solving activities.
Ability to interpret measurement and test data to evaluate product, packaging, or process performance and support root cause investigations and corrective actions.
Strong attention to detail and quality mindset consistent with regulated medical device environments.

Responsibilities

Supports design and maintenance of sterile barrier systems and protective packaging for existing products.
Supports packaging validation activities including: Sealing validation, Package performance / distribution testing, Aging studies.
Supports packaging design verification and validation testing.
Supports packaging inspection systems and labeling verification systems.
Supports packaging material specification development and maintenance.
Supports packaging BOMs, drawings, and component specifications.
Supports creation and maintenance of product labeling specifications.
Supports labeling artwork technical review and implementation of changes.
Supports multilingual labeling components including IFUs, labels, cartons, and inserts.
Supports Global Vision or equivalent labeling inspection processes.
Supports labeling change implementation and documentation updates.
Generates packaging and labeling protocols and reports.
Documents and analyzes packaging and labeling test results.
Supports risk management activities related to packaging and labeling systems.
Qualifies second source suppliers for components, materials, and packaging systems.
Supports and maintains current product and packaging design specifications.
Maintains and updates released product, packaging, and labeling specifications.
Supports CAPAs, NCMRs, and Product Complaint investigations as related to packaging, labeling, or component supply.
Supports root cause analysis and corrective action implementation.
Supports product testing and engineering studies related to sustaining design changes.
Supports vendor qualification for alternate parts, supplier changes, and cost reduction initiatives.