Device Technical Manager job in Iceland

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Data Management

Location: Iceland

This vacancy has now expired. Please see similar roles below...

A privately owned, fully integrated specialty biopharmaceutical company is looking for a talented Device Technical Manager. This role is exclusively focused on the development and manufacturing of high-quality biosimilar products. This organisation is well on its way to becoming a global leader in the biosimilar space. This organisation already has a powerful group of people that are experts in their fields, this would be the perfect opportunity to join them and excel in your chosen field.

Job Responsibilities

Leads their development project and documentation thereof from start to finish including human factors (usability) testing, design verification testing, and product finalization.
Develop and maintain technical subject matter expertise in the function and testing of the devices that are part of the organisation combination drug product.
Develop and maintain a working knowledge of regulations surrounding combination drug products.
Draft source documents for dossier filing, contribute to risk assessments and SOPs
Works with QA to maintain Design History File.
Co-ordinates and maintains samples for shipment with supply chain.
Day to day coordination of technical projects with vendors and reviews all technical documents
Coordinates outsourced engineering and assembly activities.

Skills and Requirements

MSc. Preferred. BSc. Equivalent minimally. Engineering, pharmaceutical sciences, biochemistry or related field.
Human factor engineering experience a plus. Machinery experience a plus. Demonstrated record of managing a project (academic or otherwise) a must. Demonstrated experience with statistics.
The candidate must have a demonstrated ability to work across departments.
The candidate must have a demonstrated ability to manage projects (academic or industrial).
The candidate must be organized, take initiative, be prepared to challenge and have strong communication skills.
An employee shall follow the job description that pertains to his/her position. In addition an employee shall follow the SOPs that pertains to his/her position.
An employee shall adhere to the company etiquette in all matters of behavior and manners. The employee shall take the initiative when solving a task assigned to him/her and do whatever is necessary to solve it.
It is important that an employee has the company values at heart in his/her work.
An employee shall be actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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