Sustaining Engineer

NewAge Industries, Inc.; Northern (KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

NewAge Industries, Inc. is seeking a Sustaining Engineer to maintain released products, ensure safety and compliance, and manage lifecycle activities.

You will lead or support validations for line extensions, coordinate with Quality, Regulatory, Operations, R&D, and Supply Chain, and drive continuous improvement across products and processes. The role requires hands-on experience with polymers, CAD tools, and GMP/ASME BPE knowledge, along with strong problem-solving and communication skills to

Qualifications

• Bachelor's degree in Mechanical Engineering or closely related field required.
• 3+ years in sustaining engineering, product development engineering, manufacturing engineering, or product support within regulated industries (Bio-Pharm, Medical Devices, Life Sciences).
• 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.

Responsibilities

• Provide technical support for released products to resolve design, material, manufacturing, and performance issues.
• Support root cause investigations for nonconformance, deviations, and field complaints; implement CAPAs.
• Own engineering changes (ECR/ECN) from initiation through implementation and release.
• Maintain product technical documentation; ensure design records, specs, and change docs are compliant.
• Plan and execute verification and validation activities for product/material/tooling/process changes; write protocols and reports.
• Conduct design and process risk assessments; ensure traceability and proper documentation.
• Lead or support line extensions to existing product families with risk management and validation.
• Identify and implement continuous improvement initiatives for cost, quality, manufacturability, and process optimization.
• Collaborate with Quality, Manufacturing, Supply Chain, and Regulatory teams to implement changes and support lifecycle activities.
• Support supplier/material qualification activities including alternate source approval and risk assessment.

Skills

Polymer materials

Molding

Extrusion

Film welding

Heat sealing

Fluid handling

CAD software

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

AutoCAD

CAD software

Job description

Description

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:

• Provides 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 nonconformance, deviations, and field complaints, and implement effective corrective and preventative 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 modification, 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