Rafał Pilaczyński

Production Manager at Aether Biomedical
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Contact Information
us****@****om
(386) 825-5501
Location
Poznań, Wielkopolskie, Poland, PL

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Experience

    • Poland
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Production Manager
      • Jul 2021 - Present

    • Mechanical Design Engineer
      • Apr 2020 - Present

    • Denmark
    • Wholesale Building Materials
    • 700 & Above Employee
    • Quality Assurance and Documentation Coordinator
      • Jan 2019 - Apr 2020

      - Responsibility for quality of complete technical documentation for large industrial projects - new manufacturing lines, upgrade of existing factory lines - Responsibility for fulfilling proper CE marking of equipment - assuring implementation of safe technical solutions in compliance with legal requirements and provisions of directives - Leading safety audits for compliance with Machinery Directive - Managing FMEA risk assessments (per ISO 12100-1 + ISO 13849-1) - Coordination of technical documentation delivery between internal resources, suppliers and end users in large project teams Show less

    • Denmark
    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Design Engineer - R&D
      • Jul 2017 - May 2019

      - work in Project groups (Stage Gate model). Responsibility for full mechanical design of new developed product- leading small projects (Design changes in existing products) in cooperation with other Departments of company (Quality, Production, Purchasing). Responsibility from initiation of Change Request process to its’ implementation.- Creation of high/low level project plans – management of tasks, time needed to perform and personal responsibilities.- close work in cooperation with suppliers of services (test laboratories) or suppliers of mechanical components during Development/Design change of medical device (ordering parts, solving technological issues, basic managing of supply chain for prototype building)- creating test procedures for studies verifying compliance of product with Design Specification/User Requirements including DV&V protocols- automatization of test procedures based on use of microcontrollers (hardware design, creation of software, verification of test setup etc).- technical input to creation DFMEcA/PFMEcA (Risk Analyses)- technical input to creation of Design Specifications- conducting DV&V tests and preparing reports based on statistical analysis- creating of work instructions and BOMs- work in ERP (AX2012) Show less

    • R&D Support engineer
      • Jul 2016 - Jun 2017

      - work in Project groups (Stage-Gate model)- creating test procedures (including Design Verification Protocols) during Development phase of medical device- conducting Design Verification tests and preparing reports from them;- creating technical documentation for New products (3D models, drawings). Work in SolidWorks and Creo Parametric- implementing changes in technical documentation of Existing Products- creating of work instructions, BOMs- work in ERP (AX2012)- work in cooperation with suppliers Show less

Education

  • Politechnika Poznańska
    Magister inżynier (Mgr inż.), Inżynieria biomedyczna
    2011 - 2016

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