The Sustaining Engineer is responsible for supporting the ongoing performance, compliance, and lifecycle management of released products. This role ensures that existing products remain safe, effective, compliant, and manufacturable through maintenance activities, change assessments, issue resolution, and periodic re-validation efforts. The Sustaining Engineer also leads or supports validation activities for line extensions to existing product families, ensuring new variants or modifications meet design, regulatory, quality, and manufacturing requirements. Working cross-functionally with Quality, Regulatory, Operations, R&D, and Supply Chain, this position plays a critical role in maintaining product continuity, supporting continuous improvement, and enabling successful implementation of product and process changes.

Key Job Responsibilities:

• Provide technical support for released products, resolving design, material, manufacturing, and performance issues to ensure product reliability and continuity of supply.

• Support root cause investigations for nonconformances, deviations, and field complaints, and implement effective corrective and preventive actions.

• Own engineering changes (ECR/ECN) from initiation through implementation, including scope definition, risk assessment, verification/validation, documentation updates, and controlled release.

• Maintain product technical documentation, ensuring design records, specifications, and change documentation remain accurate and compliant with applicable quality and regulatory requirements.

• Plan and execute verification and validation activities for product, material, tooling, sterilization, and process changes; author associated protocols, reports, and technical justifications.

• Conduct design and process risk assessments, ensuring traceability, mitigation, and documentation are maintained in accordance with internal procedures and regulatory expectations.

• Lead or support line extensions to existing product families, including requirements definition, design modifications, feasibility assessment, verification/validation, risk management, and implementation support.

• Identify and implement continuous improvement initiatives focused on cost reduction, quality enhancement, manufacturability, and process optimization.

• Partner cross-functionally with Quality, Manufacturing, Supply Chain, and Regulatory teams to implement changes, resolve technical issues, and support product lifecycle activities.

• Support supplier and material qualification activities, including alternate source approval, requalification, and risk assessment related to supplier, formulation, or site changes.

• Provide technical support during audits, customer inquiries, change notifications, and documentation requests.

Requirements

Education, Skills and Experience Requirements:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Plastics/Polymer Engineering, or related discipline.

• 3 + years in sustaining engineering, product development engineering, manufacturing engineering, or product support within regulated industries (Bio-Pharm, Medical Devices, Life Sciences), with experience leading projects.

• Hands-on experience with polymeric materials, molding/extrusion, film welding/heat sealing, and fluid handling assemblies.

• Hands-on experience with CAD software (SolidWorks, AutoCAD, or similar).

• Knowledge of validation practices and regulatory compliance (GMP, ASME BPE).

• Excellent problem-solving and communication skills.

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