Medical Device Technical Expert

Vor 3 Tagen

Basel, Schweiz Hobson Prior Vollzeit

Hobson Prior are currently looking for a Medical Device Technical Expert - Human Factor to join a fantastic pharmaceutical corporation on a permanent basis located in Basel. Our client is focused on producing remedies and solutions to treat various illnesses.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For this position, you will handle the cooperation between internal development associates and shareholders.
- Guide the cooperation with external development associates.
- Supervise the work progression rendering to the plan.
- Offer [packaging and device knowledge in a wider cross-functional drug product development team.
- You will review and challenge technical solutions.
- Extensive project planning and implementation.
- Assist and organise the manufacturing of clinical resources, as well as the production scale up.
- Guarantee a high-quality design history archive.
- Manage the transfer of design history archive to production.
- Any other assigned duties.

**Key Skills**:

- Able to resolve issues.
- Communication skills both verbally and in writing.

**Requirements**:

- Educated to a degree level in a packaging science/engineering or mechanical engineering discipline.
- Ideally educated to a degree level in a pertinent discipline with at least 7 years of experience in managing device development teams within a similar field.
- Fluency in the English language with knowledge in German/French would be beneficial.
- Comprehension of medical device guidelines such as FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Guideline.
- Able to handle development and writing of technical documentation of drug/device combination products and medical devices, which involves design control process and any other suitable regulatory, QA and GMP attributes.
- Comprehension of pharmaceutical development.
- Familiarity with project/program management of multifaceted projects.
- Acquaintance with handling external providers.
- Knowledge of mechanical engineering such as product design/design for manufacture, test and verification, which involves development of strategies and equipment, etc.
- Comprehension of human factors engineering, risk management and clinical studies procedures and needs.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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