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Selected Projects / Case Snapshots

Anonymized engineering case snapshots from MedTech manufacturing and R&D, focused on artifacts, execution, and verification evidence.

Details are NDA-safe. The emphasis is on what was built, how it was validated, and what evidence made decisions defensible.

Case A — Equipment qualification close-out in Swiss MedTech manufacturing

Problem

  • Qualification package incomplete and inconsistent across suppliers.
  • Missing component specifications and as-built electrical/pneumatic schematics.
  • Work instructions too thin or not tied to acceptance checks.

Approach

  • Created qualification protocols and reports aligned to IQ/OQ needs.
  • Executed stability testing where required for process evidence.
  • Authored CSV plan and report for software-backed workflows.
  • Produced as-built electrical/pneumatic schematics and component specs.
  • Reworked work instructions with step checks and data capture.

Result

  • Clear visibility of gaps and closure evidence.
  • Faster qualification close-out with fewer QA loops.
  • Improved audit readiness for equipment release.

Case B — R&D electromechanical test stand prototype

Problem

  • R&D needed a stand to explore manufacturing parameters for a new product.
  • Integration complexity across microcontroller, stepper drivers, motion, and repeatability.

Approach

  • Designed fixture and motion stack with repeatability targets.
  • Integrated microcontroller firmware, stepper drivers, and sensors.
  • Implemented logging with configuration IDs and timestamps.
  • Ran a quick GR&R to isolate dominant variation sources.
  • Tuned motion profiles and fixtures for stability.

Result

  • Working repeatable test stand enabling broader parameter testing.
  • Parameter studies supported by traceable data.

Case C — Connected HW/SW system: CSV to CSA transition driver

Problem

  • Embedded + cloud + iOS/Android ecosystem with frequent changes.
  • Small embedded library updates triggered full-system re-validation.
  • Submission-driven evidence expectations required defensible scope control.

Approach

  • Authored system specs and intended-use boundaries.
  • CSV plan and risk-based test strategy defining reduced scope.
  • Test execution, reporting, and traceability matrix.
  • SDK/component validation support to isolate changes.
  • Change-impact rules to limit re-validation blast radius.

Result

  • Clear scope for what must be re-validated per change.
  • Evidence package prepared for submission-driven evidence expectations.

Case D — R&D electromechanical test stand prototype (integration hell → repeatability)

Problem

  • Integration across motion, sensors, and embedded control kept failing.
  • Measurements were not repeatable enough for parameter studies.

Approach

  • Built a minimal electromechanical stack with controlled IO and logging.
  • Tightened fixtures and ran a quick GR&R to isolate variation.

Result

  • Repeatable measurements for R&D iterations.
  • Clear path to scale-up fixtures and evidence capture.

Case E — Legacy platform change with IEC 62304 evidence + cybersecurity test planning (anonymized)

Problem

  • Legacy firmware/library change triggered broad re-validation.
  • Cybersecurity testing was not mapped to evidence expectations.

Approach

  • Defined change scope and the IEC 62304 evidence delta.
  • Built a cybersecurity test plan aligned to submission-driven evidence expectations.

Result

  • Re-validation scope limited to impacted components.
  • Evidence package ready for audit/submission context.

Case F — Field retrofit sprint for a cover-staining line (anonymized)

Problem

  • EOL main controller forced a platform change.
  • Field issues showed up after a safety subsystem integration change.
  • Process module variability drove occasional cover glass defects.

Approach

  • Root-cause analysis across field logs, mechanics, and integration logic.
  • Retrofit plan with verification steps and acceptance criteria.
  • Prototype improvements to the process module with targeted tests.
  • Evidence updates for change control and re-validation.

Result

  • Stabilized field behavior with a documented retrofit path.
  • Clearer verification evidence for QA close-out.

Case G — Cryosurgery device connector redesign (anonymized)

Problem

  • Single connector had to combine EEPROM, pneumatics, and power interfaces.
  • Connector robustness and material compatibility were limiting reliability.

Approach

  • Redesigned connector architecture with clearer interface separation.
  • Mapped EEPROM handling and pinout compatibility for legacy systems.
  • Explored materials and coating trials (e.g., parylene) for durability.
  • Built prototypes and verification checks for fit and sealing.

Result

  • More robust connector concept ready for transfer.
  • Evidence pack for future validation and manufacturing handover.