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MES Manufacturing Engineer

Staar Surgical Company · Brugg

Nouveau
Senior 🇬🇧 English
T-SQL SQL Server Oracle ERP Oracle Integration Cloud C# .NET MES ISO 13485 21 CFR Part 11 ALCOA+

Description du poste

About the role

The MES Manufacturing Engineer is the site's primary point of contact for STAAR Surgical's custom Manufacturing Execution System. It is a hands-on role spent mostly on the production floor with operators in manufacturing, packaging and shipping, resolving issues at the workstation and acting as liaison to the IT service desk and the MES development team. The position covers day shift with on-call escalation support, based in Brugg/Nidau.

Key responsibilities

  • Provide first-line MES support to operators, leads and supervisors, diagnose issues using logs and queries, and escalate out-of-scope problems with complete detail.
  • Support the floor hardware: Windows tablets and desktops, barcode scanners and label printers (SATO, Printronix, Zebra).
  • Monitor MES availability and its ERP interfaces (work order release, job pull sheets, serial numbers) and restore them when disrupted.
  • Debug issues in a non-production environment, trace them to SQL Server tables and audit records, and write defect reports with reproducible steps and evidence.
  • Investigate MES-to-Oracle ERP discrepancies via interface staging records and Oracle Integration Cloud, and coordinate corrections with the ERP team.
  • Keep service desk tickets up to date, track issues to closure, and write knowledge-base articles for recurring problems.
  • Support nonconformances for system and data issues, contributing to root-cause analysis and preparing approved data corrections to protect Device History Record integrity.
  • Translate operator needs into requests for the service desk, developers or vendors, and represent the site in release planning.
  • Gather and document business requirements for enhancements, define test scenarios, run user acceptance testing and follow change control and electronic QMS (Kneat) under ISO 13485 / QMSR, 21 CFR Part 11, ALCOA+ and SOX IT controls.
  • Create user guides, work instructions and training, and coach operators at their workstations.

Required profile

  • Undergraduate degree and 6-8 years of relevant experience, or graduate degree and 4-6 years.
  • 3-5 years supporting manufacturing applications and floor hardware in a production environment; MES and ERP experience strongly preferred.
  • Experience supporting end users on a production floor across manufacturing, packaging and shipping.
  • Understanding of the order-to-production life cycle (ERP order entry, work order creation, job pull sheets) and of ERP manufacturing modules.
  • Experience in a regulated medical device environment: change control, validation, documentation discipline, nonconformances and service desk tickets.
  • Fluent English; German and French a plus.

Required skills

  • Working T-SQL and ability to relate application behaviour to the data model; reading C#/.NET code is a plus.
  • MES-to-ERP integration, ideally Oracle ERP and Oracle Integration Cloud.
  • Analytical and problem-solving skills, and strong communication with both operators and engineers.

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Staar Surgical Company

Brugg