Position Summary
The Sustaining Engineer is responsible for leading cross-functional projects and engineering initiatives that support the continued manufacture, regulatory compliance, and supply of commercialized medical devices. This role serves as a key liaison between Engineering, Quality, Regulatory Affairs, Supply Chain, Manufacturing, and external suppliers to evaluate, implement, and document product, component, material, and packaging changes.
The Sustaining Engineer drives timely resolution of technical and supply-related challenges affecting on-market products by developing risk-based solutions, coordinating design and validation activities, and executing change management processes. This position plays a critical role in ensuring continuity of supply, product quality, and compliance with applicable regulatory requirements.
Essential Duties and Responsibilities:Sustaining Engineering & Product Lifecycle Management
- Lead cross-functional projects supporting on-market products, ensuring clear ownership, action plans, milestones, risk mitigation strategies, and successful project execution.
- Resolve product, component, material, and packaging issues that could impact the continuity of supply for commercialized products.
- Investigate technical issues and collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, and Supplier Quality teams to develop and implement effective solutions.
- Support product lifecycle management activities, including design updates, risk assessments, documentation revisions, and product improvements.
Change Management
- Prepare, coordinate, and execute engineering change activities to support product, component, material, and packaging updates.
- Develop and maintain documentation including:
- Engineering Change Orders (ECOs)
- Commodity Specifications
- Technical Drawings
- Change Control Plans
- Design and Development Plans
- Technical Assessments and Reports
- Ensure all changes are implemented in accordance with quality system requirements and regulatory expectations.
Supplier & Component Management
- Partner with Supplier Quality and Supply Chain teams to assess Supplier Change Notifications (SCNs) and evaluate the impact of supplier-driven changes.
- Coordinate technical assessments and testing associated with changes to resins, components, packaging materials, and other supplied products.
- Collaborate with suppliers and internal stakeholders to mitigate risks and maintain uninterrupted product supply.
Validation & Verification
- Coordinate and support product verification, validation, and qualification activities associated with design, component, material, and packaging changes.
- Prepare and execute validation protocols and reports, including:
- Packaging Validations
- Accelerated Aging Studies
- Material Assessments
- Design Verification Testing
- Partner with Quality and Regulatory teams to ensure compliance with applicable standards and internal requirements.
Communication & Reporting
- Provide regular project updates to management and key stakeholders regarding timelines, risks, contingency plans, and project status.
- Prepare technical reports, presentations, data analyses, graphs, and project documentation to support decision-making and regulatory compliance.
- Facilitate effective communication among cross-functional teams, suppliers, and manufacturing sites.
Compliance & Continuous Improvement
- Ensure compliance with FDA, ISO, cGMP, and internal quality system requirements related to medical device manufacturing.
- Follow applicable procedures, work instructions, and regulatory requirements governing design changes and sustaining engineering activities.
- Participate in continuous improvement initiatives that enhance product quality, supply reliability, and operational efficiency.
- Perform other sustaining engineering and project-related responsibilities as assigned.
Knowledge, Skills, and Abilities
- Strong understanding of medical device manufacturing and/or pharmaceutical regulated environments, including FDA regulations, cGMP requirements, and documentation practices.
- Knowledge of medical device packaging systems, packaging validation, and accelerated aging methodologies.
- Experience managing engineering change processes within a regulated manufacturing environment.
- Proficiency in statistical analysis and problem-solving tools, including Minitab.
- Ability to interpret technical drawings, specifications, engineering standards, and test methods.
- Working knowledge of SolidWorks or similar CAD software.
- Experience with project planning and tracking tools, including Microsoft Project.
- Strong analytical and problem-solving skills with the ability to assess technical and business impacts of change.
- Excellent written and verbal communication skills with the ability to interact effectively across all levels of the organization and with external suppliers.
- Ability to manage multiple projects and priorities in a fast-paced, regulated environment.
- Understanding of design controls, risk management, and product lifecycle management principles.
Minimum Qualifications
Education
- Bachelor’s degree in engineering from an accredited college or university required.
Experience
- Minimum of 5 years of experience in the medical device industry, or a combination of medical device and pharmaceutical industry experience or other relevant experience.
- Experience supporting product changes, validation activities, and regulated manufacturing processes preferred.
Other Requirements
- Must be at least 18 years of age.
Work Environment
- Work is performed in both office and manufacturing environments, including cleanroom operations and automated production areas.
- Regular interaction with manufacturing personnel, technical teams, and suppliers is required.
- Position may require visits to manufacturing sites and supplier facilities; strong customer-facing and professional communication skills are essential.
- Ability to work in production and laboratory environments as needed to support testing, validation, and process investigations.
- Travel is typically less than 10%.