Product Development Engineer

Proclinical are recruiting a Product Development Engineer for a pharmaceutical establishment. This role is on a contract basis and is located in Oberdorf. The client is focused on producing a healthier population.

Responsibilities:

• You will work towards quarterly objectives, offer weekly task updates and project status.
• Conduct any other unique projects and functions as tasked.
• Evaluate and sanction any necessary drawing updates, which involves design influence examinations.
• To assist design engineering rationales/memos as needed, you will implement tactics and design/procedure excellence tools.
• To meet EU MDR needs, you will help analysing current reports, evaluating gaps, reviewing reports, producing engineering rationales.
• Acknowledge and adhere to all laws and guidelines that apply to the role, as well as sustain the highest levels of competence, morals and amenability at all times.
• The ideal candidate will plan, evaluate and sanction documents to assist with technical reports to meet MDR needs.
• When needed, review and consent to verification and validation actions.
• To converse and review papers to meet MDR needs, you will contribute to cross-functional teams.
• Other duties may be assigned to this role.

Skills & Requirements:

• Educated to a degree level with at least 3 years of experience or educated to an advanced degree level with at least 1-2 years of experience in an engineering or life science discipline.
• At least 1.5 - 2 years of experience as an associate development engineer or obtain mechanical experience such as construction, production, etc.
• Knowledge of ISO 13485 and ISO 9001, QSR Medical Devices appropriate necessities, specifically Council Directive 93/42/EEC and Regulation 2017/745, as they relate to technical documents.
• Familiarity with Design History Files such as Technical Files.
• Biomechanics, biology, anatomy know-how.
• Comprehension of risk management procedures, label and labelling, change management.
• Experience within a global aspect of the industry.
• Communication abilities, both written and verbally.
• Project management acquaintance.
• Qualification in program/project management would be beneficial but not necessary for the role.
• Computer literacy in Microsoft Office, CAD/CAM, databases, etc.
• Know-how and capabilities in PLM system, agile PLM, SAP, Windchill, Adaptive would be advantageous.
• An organised individual who is inventive, coherent, and analytical.
• Social and political abilities.
• Capable of working on various tasks simultaneously as well as self-sufficiently under minimal supervision.

If you are having difficulty in applying or if you have any questions, please contact Sasha Botha at +41 61 568 79 88.

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

Proclinical Staffing is an equal opportunity employer.

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