Engineer Pre-Fillable Syringe (temporary for 2 years, working time 80-100%)

Job description

  Job facts

The specific responsibilities of this challenging position within our Pre-Fillable Syringe Team include:

·  Apply mechanical engineering skills to create innovative, reliable, and effective medical devices
·  Execute portfolio projects within the agreed time – quality – cost frame resulting in state-of-the-art and competitive devices and related combination products and production processes ready for filing. Provide high quality input and documentation for interaction with regulatory authorities. Drive device development for biologics to new states and standards as needed by our portfolio
·  Develop project/product device strategy in collaboration with partners and stakeholders. Establish technical product requirements to assure devices maintain performance of the product they intend to deliver
·  Collaborate effectively with partners in Technical Research and Development, Quality, Commercial Manufacturing in developing aligned strategies and concepts for the development of combination products for biologics and ensuring seamless handover of projects and aligned development of technologies and knowledge. Act as ambassador for Device Development
·  Apply your knowledge of the regulatory landscape to ensure standard compliant designs, working to Quality Management Systems such as ISO 13485, and 21CFR820, risk management to ISO14971, design control, compilation of Design History File, verification and validation and clinical trial/manufacture support
·  Develop mathematical and statistical models to understand impact of primary packaging attributes on drug administration. Utilise engineering and analysis tools to ensure robust designs and understand device limitations (e.g. root cause analysis, tolerance analysis, finite elements analysis, probabilistic design)
·  Maintain knowledge of relevant legislation, regulation, and industry trends in the field of Medical Devices and Combination Products. Maintain own specialist expertise through exposure, education, training, and application. Comply with internal and external requirements in all aspects of operations. Act in compliance with Pharmaceutical Quality System, local Standard Operating Procedures, Corporate Values and Behaviors

·  Who we are

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more .

Roche is an equal opportunity employer.

Desired profile

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Your destiny is to work on solutions which will safe human life. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies.

As the ideal candidate you have a university level education (engineering degree or related discipline) and 2-3 years proven track record in mechanical engineering and primary packaging development. You should also bring demonstrable knowledge of parenteral drug container and delivery (including devices such as pre-filled syringes, closure systems, auto-injectors, needle safety devices, or other novel injection technologies). Other requirements for this job are:

·  Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices as well as strong market awareness/network and a capability to identify and develop new technology opportunities
·  Enthusiastic team player with good communication and collaboration skills. Good analytical, practical, and creative skills
·  Excellent command of English language
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