Staff Sustaining Engineer

Staff / Senior Staff Sustaining EngineerI'm partnering with a commercial-stage medical device company to hire a Staff or Senior Staff Sustaining Engineer. You'll be the technical lead keeping a commercial disposable device line reliable, manufacturable and performing well in the field.The RoleYou'll own complex product issues end to end: complaints, CAPAs, field problems, supplier and material changes, and manufacturing issues. You'll lead each one from root cause through closure, working across Quality, Manufacturing, Regulatory, Supply Chain and R&D.

The environment moves fast and priorities can shift quickly, so you'll need to be comfortable reprioritizing while keeping ownership.ResponsibilitiesLead sustaining engineering for commercial productsInvestigate and resolve complaints, field issues, manufacturing problems and customer escalationsLead CAPA, root-cause analysis, corrective actions and effectiveness checksEvaluate and implement material, component, supplier and process changes, including risk assessment and V&VDrive biocompatibility, sterility and sterile barrier testing, coordinating with external test labsPerform design verification, design validation and process validation, and prepare documentation for regulatory submissionsAnalyze complaint, manufacturing and field data to spot trends earlySupport product improvements, cost reductions, supply continuity and obsolescence managementMaintain specifications, drawings, risk files and test methodsMentor engineers and guide cross-functional teamsQualificationsBS or higher in Mechanical, Biomedical, Materials, Manufacturing or related engineering8+ years of experience for Staff, 10+ for Senior StaffBroad sustaining, product, manufacturing or quality engineering experience on commercial productsStrong track record with CAPA, root-cause investigations, complaints and field issuesExperience implementing material, supplier or process changesProven ability to lead cross-functional issues to closureExperience in a regulated development or manufacturing environmentPreferredDisposable or single-use medical device experienceISO 13485, FDA QSR, design controls and risk managementPolymers, adhesives, molded components, assemblies or packagingProduct or mechanical design backgroundStatistical methods and data analysis