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Operations and Quality Engineer, Sustaining Engineering

Lila Sciences· Autonomous Science Platform
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Cambridge, MA$93.6k - $158.4kFull-timePosted 3mo ago

About the role

Engineered role to establish and evolve quality management systems, CMMS, PLM, operational standards, and continuous improvement infrastructure to scale AISFs across geographies and deployments, embedding quality and continued engineering velocity.

Responsibilities

  • Establish and maintain an ISO 9000 aligned QMS framework tailored to hardware-software-operations environments
  • Own quality policy, operational procedures, document control, and record retention across the AISF platform lifecycle
  • Define audit-ready traceability and configuration control standards for engineering changes, deployments, and operational baselines
  • Build scalable quality templates and workflows that engineering teams want to use
  • Ensure QMS evolves with organizational growth—lightweight early, rigorous at scale
  • Support operationalization of Arena PLM (or equivalent) for AISF bill-of-materials, part numbering, and engineering change control
  • Own the Engineering Change Management (ECM) process end to end—drive ECOs and ECRs from initiation through review, approval, implementation, and closure
  • Own release structure, design documentation, and deployment baselines to ensure every AISF deployment is traceable to an engineering release
  • Maintain operational lineage: which hardware, software, and firmware versions are deployed at which sites, and why
  • Support commissioning, FAT/SAT documentation, and handoff records with regulatory-grade rigor
  • Partner with Engineering, Robotics, Software, Manufacturing, and Facilities to define shared standards for operational readiness, quality gate criteria, and deployment workflows
  • Lead risk and reliability practices: facilitate FMEA across design and process, and translate findings into mitigations
  • Develop and maintain Control Plans linking critical characteristics, process controls, inspection methods, and reaction plans
  • Lead standards definition for design reviews, safety compliance, manufacturing readiness, and operational handoff
  • Build operational templates for engineering change requests, deployment checklists, and incident response
  • Serve as the quality authority in technical forums; own escalation paths for quality-critical decisions
  • Maintain quality metrics and trending: first-pass yield, escape rates, CAPA effectiveness, cycle time, deployment readiness
  • Prepare audit-ready documentation and compliance evidence for regulatory bodies, customers, and internal stakeholders
  • Define and maintain quality KPIs aligned with business growth and deployment scale
  • Lead internal quality audits; prepare corrective action plans for findings

Qualifications

  • 3+ years in quality, operations, or engineering roles in hardware, manufacturing, or complex systems environments (automotive, medical device, aerospace, robotics, semiconductor, or industrial equipment)
  • Hands-on expertise building or scaling ISO 9000 compliant quality systems—document control, procedure discipline, audit readiness
  • Demonstrated experience leading RCA investigations and CAPA programs—driven teams through root-cause discipline, tracked corrective actions to closure, and verified effectiveness
  • Comfort with Arena PLM, Windchill, SAP PLM, or equivalent lifecycle management systems—part numbering, bill-of-materials rigor, and design change control
  • Hands-on experience running Engineering Change Management (ECM)—owned ECO/ECR workflows from initiation through implementation and closure
  • Experience developing FMEAs and Control Plans—lead cross-functional risk assessments and translate into concrete process controls and reaction plans
  • Track record building operational templates, procedures, and workflow standards that teams actually adopt
  • Strong cross-functional leadership skills—communicate with engineers, operators, finance, and executives without losing precision

Skills

Required:ISO 9000 quality system implementationECM / ECO/ECR lifecycle managementFMEA and Control PlansArena PLM / PLM systemsQuality metrics & CAPA

Benefits

  • We offer comprehensive compensation with base salary, bonus potential, and generous early-stage equity
  • U.S. benefits: medical, dental, vision; employer-paid life and disability; paid time off with holidays; parental leave; educational assistance; commuter benefits; subsidized lunch program
  • International benefits tailored to region; USD salary ranges apply to U.S.-based positions; international salaries set to local market
Last updated Sep 2, 2026. Interested? Apply on the company site.
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About Lila Sciences

Pioneering Scientific Superintelligence

Pioneering Scientific Superintelligence to solve humankind’s greatest challenges.

Scientific SuperintelligenceAIAutonomous LabsLife SciencesChemical SciencesMaterials Sciences
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