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Device Engineer - Risk Management
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineer, Design, Engineering
Projektbeschreibung
For our client in BASEL we are looking for a DEVICE ENGINEER - RISK MANAGEMENT for a 6 MONTHS contract.
DURATION: 01/10/2018 TO 31/03/2019 (EXTENSION POSSIBLE)
LOCATION: BASEL
WORKLOAD: 100%
JOB TITLE: DEVICE ENGINEER - RISK MANAGEMENT
MAIN TASKS:
. Lead specific medical device risk management activities within projects as agreed with project leaders
. Work with device development teams to incorporate risk management during all phases of the product life cycle from development of new products to maintenance of marketed products
. Facilitate preparation of risk analyses together with subject matter experts
. Author all relevant documents of the medical device risk management file, i.p. risk management plans, hazard analyses, risk analyses of use, design and manufacturing of medical devices, and risk management reports
. Provide guidance and training about the application of risk management on medical devices to all internal and external functions involved in risk management activities
. Ensure compliance with regulatory and normative guidelines (i.p. FDA CFR 820, ISO13485 and ISO 14971, MDR)
. Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.
An ideal candidate would have at least 5 years of experience in risk management as part of device development of drug delivery systems or drug/device combination products and experience in generating DHF documentation
REQUIREMENT FOR THE ROLE ARE:
. Excellent technical writing skills
. Strong communication skills
. Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
. Experience in product design and design for manufacturing
. Good technical knowledge about primary packaging materials and drug delivery devices
. General understanding of human factors engineering, clinical trial processes and requirements and pharmaceutical development
For further details please contact:
Anna Undas
(see below)
DURATION: 01/10/2018 TO 31/03/2019 (EXTENSION POSSIBLE)
LOCATION: BASEL
WORKLOAD: 100%
JOB TITLE: DEVICE ENGINEER - RISK MANAGEMENT
MAIN TASKS:
. Lead specific medical device risk management activities within projects as agreed with project leaders
. Work with device development teams to incorporate risk management during all phases of the product life cycle from development of new products to maintenance of marketed products
. Facilitate preparation of risk analyses together with subject matter experts
. Author all relevant documents of the medical device risk management file, i.p. risk management plans, hazard analyses, risk analyses of use, design and manufacturing of medical devices, and risk management reports
. Provide guidance and training about the application of risk management on medical devices to all internal and external functions involved in risk management activities
. Ensure compliance with regulatory and normative guidelines (i.p. FDA CFR 820, ISO13485 and ISO 14971, MDR)
. Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.
An ideal candidate would have at least 5 years of experience in risk management as part of device development of drug delivery systems or drug/device combination products and experience in generating DHF documentation
REQUIREMENT FOR THE ROLE ARE:
. Excellent technical writing skills
. Strong communication skills
. Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
. Experience in product design and design for manufacturing
. Good technical knowledge about primary packaging materials and drug delivery devices
. General understanding of human factors engineering, clinical trial processes and requirements and pharmaceutical development
For further details please contact:
Anna Undas
(see below)
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Medien/Design, Ingenieurwesen/Technik