Senior Sustaining Engineer

Position Summary

The Senior Sustaining Engineer is a cross-functional technical leader responsible for supporting commercialized products throughout their lifecycle. This role owns product changes, resolves complex manufacturing and quality issues, and drives improvements in product reliability, manufacturability, quality, supply continuity, and cost. The engineer partners with Quality, Manufacturing, Supply Chain, Regulatory Affairs, R&D, and contract manufacturers to ensure product performance and compliance.

Primary Responsibilities

• Lead sustaining engineering programs for released products from problem identification through implementation and closure.
• Own technical investigations involving manufacturing, supplier, field, and quality issues through resolution. Leverage knowledge of quality issues to inform new product development.
• Lead Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs) through release and implementation.
• Conduct change impact assessments covering form, fit, function, regulatory, inventory, supplier, tooling, validation, and documentation impacts.
• Coordinate production implementation activities including training, work instruction updates, material disposition, and supplier readiness.
• Utilize SolidWorks and related tools to develop and implement design improvements.
• Develop and maintain drawings, specifications, BOMs, DHF, DMR, and related technical documentation.
• Lead root cause investigations, CAPAs, and corrective actions using structured problem-solving methodologies and project management.
• Support IQ/OQ/PQ validations, DFM/DFA initiatives, and manufacturing process improvements.
• Collaborate with R&D, Manufacturing, Quality, Supply Chain, and suppliers to improve quality, reliability, manufacturability, and cost.
• Ensure compliance with FDA, ISO 13485, ISO 14971, and applicable regulatory requirements.
• Lead vendor meetings as necessary.
• Assist in vendor selection activities.

Required Qualifications

• Bachelor's degree in Mechanical, Biomedical, Manufacturing Engineering, or related field.
• 8+ years of sustaining, product, manufacturing, or quality engineering experience.
• Proficiency in SOLIDWORKS, 3D modeling, 3D printing, and prototyping.
• Experience with design controls, change management, CAPA, and product lifecycle management.
• Strong understanding of FDA and ISO-regulated medical device environments.
• Experience working with contract manufacturers and global suppliers.
• Demonstrated technical leadership and cross-functional project management skills.