Medical Device Development Project Leader

Key People


Job ID :

14906


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

Western Europe,Switzerland,Basel-City,


Key Skills :

medical devices, packaging, development, engineer, project management


Salary :

€700 - €800 per day


Date Posted :

14 May, 2019



Company Name :

Key People


Location1 :

Basel-City




Job Category :

Clinical Research Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

100.00%





Description

Particularly relevant:

* Thorough project planning
* Provide primary packaging and device expertise in a broader cross-functional drug product development team
* Leading Risk management activities
* Planning and monitoring of design verification activities (in-house)
* Leading and authoring technical documentation
* Ensuring a high-quality Design History file
* Transfer of Design History File to production


Education (minimum):

Bachelor's or Master degree in Packaging Science/Engineering or Mechanical Engineering or University
level Engineering education.
An ideal candidate would have a relevant degree in engineering and at least 7 years' experience in
leading device development technical teams in a similar area
Languages
Required
Fluency in English language is required.


Desirable experience:

Proficiency in German/French advantageous.
Experience/Professional requirement:
Particular relevant experience:
* Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device
Directive, EU Medical Device Regulation)
* Development and writing of technical documentation of drug/device combination products and
medical devices, including Design Control process and other applicable regulatory, QA and GMP
aspects
* Mechanical engineering in general
o Test and verification, incl. development of methods and equipment
* General understanding of Human Factors Engineering, risk management and clinical studies
processes and requirements


Desirable experience:

* Mechanical engineering in general
o Product design/Design for manufacture
* Good understanding of pharmaceutical development in general
* Experience in project / program management of complex projects
* Considerable experience of managing external suppliers
* Good communication and conflict solving skills


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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