SENIOR TEST ENGINEER

Azienda

Azienda multinazionale specializzata nella produzione e commercializzazione di variegati prodotti e servizi per l'industria farmaceutica CERCA.

Descrizione

Jefferson Wells, through its specialized division Life Sciences division, for prestigious client company operating in the medical devices sector is looking for a:
TESTING ENGINEER Senior
EXPERIENCE
At least 6
???? years of experience in the role in pharma, pharmaceutical packaging, drug delivery systems, medical device (such as autoinjectors, pens or wearables)
EDUCATION
Engineer with Master's degree in materials science, physics, mechanical, mechatronic or biomedical application or equivalent.

Requisiti

QUALIFICATION PROFILE
General & Technical Skills
Experience in EVT and DVT testing for drug delivery system and medical devices (DDS/MD)
Testing capability to enable design, verification, validation and transfer of DDS/MD related test methods according to regulated environment according to ISO 13485, and /or CFR 820.30
Knowledge of standard and regulations most applied to MD such as ISO 13485, CFR 820.30, MDR 745/2017 (in alternative to MDD 93/42), IVDR 746/2017. Experience in Risk management according to ISO 14971 appreciated
Familiarity with Design of Experiment concepts and techniques
Robust background in Statistical • yellow belt certification well evaluated, green belt outstanding
Well•established experience in Test methods and fixturing systems development and customization
Mechanical and/or electric aptitude and materials knowledge are required (glass, plastic and rubber preferred)
Knowledge of applicable standards (e.g. ISO 11608, ISO13926, ISO80369), guidelines and regulations creating test environments
Analyzing results and identifying the root cause of malfunctions
Simulation transportation testing
Stress/accelerated testing, stability testing, shelf•life studies related performance testing (e.g. ASTM F1980)
Familiarity with various testing techniques
Data analysis, elaboration and reporting
Troubleshooting skills
Analytical mindset
Statistical analysis of dataset
Knowledge of metrology and instrument calibration
IQ, OQ, PQ, FAT, SAT (preferred)
Experience with risk management (e.g. PFMEA)
Proficient with Software's: good knowledge of Minitab, Origin, CAD, Office and Mathematical simulation software as EM, CFD and Ansys (preferred)
3D printing (preferred)
Failure root cause analysis and/or fractography (preferred)
Knowledge of laboratory equipment:
Tensile machines (dynamometers and tribometers),
Microscopic/optical•based instruments (light microscopy, Scanning Electron Microscopy, etc.)
All the activities have to comply with ISO 13485, 21 CFR 820.30, MDR 745/2017, IVDR 746/2017 and ISO 14971
Location: Veneto

Luogo di lavoro:

PADOVA

Disponibilità:

Assunzione diretta

Tipologia:

Full Time

Data pubblicazione:

22/11/2021

Codice annuncio:

31327

Visualizzazioni annuncio:

173

Nome filiale:

723 LIFE SCIENCES JEFF. WEL

Numero di candidati ricercati:

1
NOTE LEGALI:
Experis è una compagnia eticamente responsabile. Il servizio è gratuito. I candidati ambosessi (L.903/77 - D.Lgs. n.198/2006) sono invitati a leggere l'informativa Privacy su www.experis.it Aut. Min. Prot. N. 1116 - SG - del 26/11/04.
Il titolare della registrazione e/o candidatura dichiara di essere a conoscenza delle sanzioni penali previste in caso di dichiarazioni mendaci o contenenti dati non più rispondenti a verità come previsto dal D.P.R. nº445 del 28.12.2000

SENIOR TEST ENGINEER

PADOVA
Assunzione diretta
Full Time
22/11/2021
31327
173
723 LIFE SCIENCES JEFF. WEL
1

Azienda

Azienda multinazionale specializzata nella produzione e commercializzazione di variegati prodotti e servizi per l'industria farmaceutica CERCA.

Descrizione

Jefferson Wells, through its specialized division Life Sciences division, for prestigious client company operating in the medical devices sector is looking for a:
TESTING ENGINEER Senior
EXPERIENCE
At least 6
???? years of experience in the role in pharma, pharmaceutical packaging, drug delivery systems, medical device (such as autoinjectors, pens or wearables)
EDUCATION
Engineer with Master's degree in materials science, physics, mechanical, mechatronic or biomedical application or equivalent.

Requisiti

QUALIFICATION PROFILE
General & Technical Skills
Experience in EVT and DVT testing for drug delivery system and medical devices (DDS/MD)
Testing capability to enable design, verification, validation and transfer of DDS/MD related test methods according to regulated environment according to ISO 13485, and /or CFR 820.30
Knowledge of standard and regulations most applied to MD such as ISO 13485, CFR 820.30, MDR 745/2017 (in alternative to MDD 93/42), IVDR 746/2017. Experience in Risk management according to ISO 14971 appreciated
Familiarity with Design of Experiment concepts and techniques
Robust background in Statistical • yellow belt certification well evaluated, green belt outstanding
Well•established experience in Test methods and fixturing systems development and customization
Mechanical and/or electric aptitude and materials knowledge are required (glass, plastic and rubber preferred)
Knowledge of applicable standards (e.g. ISO 11608, ISO13926, ISO80369), guidelines and regulations creating test environments
Analyzing results and identifying the root cause of malfunctions
Simulation transportation testing
Stress/accelerated testing, stability testing, shelf•life studies related performance testing (e.g. ASTM F1980)
Familiarity with various testing techniques
Data analysis, elaboration and reporting
Troubleshooting skills
Analytical mindset
Statistical analysis of dataset
Knowledge of metrology and instrument calibration
IQ, OQ, PQ, FAT, SAT (preferred)
Experience with risk management (e.g. PFMEA)
Proficient with Software's: good knowledge of Minitab, Origin, CAD, Office and Mathematical simulation software as EM, CFD and Ansys (preferred)
3D printing (preferred)
Failure root cause analysis and/or fractography (preferred)
Knowledge of laboratory equipment:
Tensile machines (dynamometers and tribometers),
Microscopic/optical•based instruments (light microscopy, Scanning Electron Microscopy, etc.)
All the activities have to comply with ISO 13485, 21 CFR 820.30, MDR 745/2017, IVDR 746/2017 and ISO 14971
Location: Veneto
NOTE LEGALI:
Experis è una compagnia eticamente responsabile. Il servizio è gratuito. I candidati ambosessi (L.903/77 - D.Lgs. n.198/2006) sono invitati a leggere l'informativa Privacy su www.experis.it Aut. Min. Prot. N. 1116 - SG - del 26/11/04.
Il titolare della registrazione e/o candidatura dichiara di essere a conoscenza delle sanzioni penali previste in caso di dichiarazioni mendaci o contenenti dati non più rispondenti a verità come previsto dal D.P.R. nº445 del 28.12.2000