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Team Company

The engineers behind Techkrates

I run Techkrates in Zurich and lead every project myself, from the first call to handover. Electronics is developed with Patrick Keller, and specialist partners join when a project needs them.

Filip Jaromczyk

How we staff a project

“I lead projects personally and assemble the engineering team needed for the agreed scope.”

Filip Jaromczyk, founder
  1. We agree scope, deliverables and acceptance criteria with you.
  2. Engineers are assigned by discipline: mechanical, electronics, verification, qualification.
  3. Design, test and qualification work follows one plan and one documentation structure.
  4. You keep one technical contact until handover.
Filip Jaromczyk

Founder • Project lead

Filip Jaromczyk

Mechanical/mechatronics engineer focused on regulated hardware in MedTech manufacturing. At Agilent, Design Responsible for an IVD pathology instrument. At Ypsomed, design verification of autoinjectors, plus test stands, fixtures and cobot integration. For a Swiss medical device manufacturer, planned and ran the DQ to PQ qualification of two production machines and wrote the FAT and SAT. Leads every Techkrates project from scoping to handover.

Experience

  • Hands-on delivery: from requirements/URS through DQ/IQ/OQ/PQ to cleanroom execution and QA-ready reports.
  • Pragmatic test solutions: fixtures, jigs, automation, prototypes.
  • Typical tech: CAD design, Arduino/STM32, steppers/servos, sensors, pneumatic interfaces, data logging & simple UIs.
  • ISO 10993 biocompatibility and FDA 21 CFR 820 (QMSR).
  • Traceability, risk management, ECO/ECR, obsolescence.
  • Verification tools: IBM DOORS, HP ALM, Jira. ISTQB Certified Tester, Foundation Level (CTFL).
  • Regulated mindset: tight scope, evidence-based, traceable.
  • Based in Zurich, on-site in Switzerland and Germany.
  • Languages: English / German.
PK

Electronics engineering lead

Patrick Keller

Electronics engineer with more than ten years in MedTech electronics development. Covers the complete electronics workflow at Techkrates, from requirements to tested and documented hardware.

Experience

  • Electronics requirements and architecture
  • Circuit design and PCB layout
  • Embedded firmware
  • Design for IEC 60601 electrical safety and EMC (IEC 60601-1-2)
  • Usability engineering to IEC 62366-1
  • Pre-compliance testing, verification testing and test documentation
  • Design documentation and transfer to production

Network

Lucia Bartos

QA Specialist (associate)

Lucia Bartos

More than ten years in MedTech and electronics manufacturing, the recent years in quality assurance, including an implantable medical device. Works in German and English. Available as additional QA capacity on larger projects.

Experience

  • Incoming, in-process and final inspection
  • Nonconforming material (NCMR) and deviations
  • CAPA and change control
  • Supplier evaluation and document review
  • SOP and work instruction reviews
  • Calibration
Focus
Product development (mechanical, electronics, firmware) • Verification and test engineering • Test stands/fixtures & jigs • Equipment qualification (DQ/IQ/OQ/PQ) • FAT/SAT and commissioning support • CSV/CSA • Machinery safety and CE for in-house built equipment • Sustaining engineering • Automation • Robotics (cobots) • Productivity improvements
Environment
Medical devices • MedTech / biotech manufacturing • regulated • cleanroom / production
Standards

Quality & regulatory

  • ISO 13485
  • ISO 14971
  • FDA 21 CFR 820 (QMSR)
  • 21 CFR Part 11
  • MDR
  • IVDR

Device design

  • IEC 60601-1
  • IEC 60601-1-2 (EMC)
  • IEC 62366-1
  • IEC 62304
  • ISO 10993
  • ISO 11608

Manufacturing & validation

  • ISO 14644
  • GAMP 5
  • EU GMP Annex 11

Machinery safety

  • ISO 12100
  • ISO 13849-1
  • IEC 60204-1

Specialist partners

For PLC/SPS integration, machining and other specialist work we bring in trusted partners, selected per project and coordinated by the project lead.

Discuss a project with us

Send 2–3 lines about what you are developing, testing or qualifying. We reply within 24 hours.

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