Rafał Pilaczyński
Production Manager at Aether Biomedical- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Experience
-
Aether Biomedical
-
Poland
-
Medical Equipment Manufacturing
-
1 - 100 Employee
-
Production Manager
-
Jul 2021 - Present
-
-
Mechanical Design Engineer
-
Apr 2020 - Present
-
-
-
ROCKWOOL Group
-
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
-
-
-
LiNA Medical
-
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