Device Engineer (Temporary contract)
The Device Development Department within Roche Technical Development is
responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support.
Roche is recruiting for a (senior) Device Engineer to support the development and maintenance of drug delivery devices (e.g. Prefilled Syringes with Needle Safety Devices, Autoinjectors, high-volume Patch-injectors).
The Device Engineering group performs combine design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities.
This role will require considerable cross-functional interaction, notably including QA, Regulatory Affairs, Clinical and Commercial functions. The Device Engineer will report to the Section Head of Device Engineering and will be integrated into the Roche Device Development function.
As a Device Engineer, your primary responsibilities include:
Act as project leader to successfully bring combination products and medical devices to the market
Evaluation of new and breakthrough technologies. Application of theoretical engineering knowledge, to establish robust technical product requirements and develop engineering design solutions to assure devices maintain the required level of performance throughout the life of the product
Author design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance DHF), conformity assessments and risk management documentation.
Forecast and plan resource demands for device development projects.
Execute projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices
Apply your knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30)
As a Device Engineer, you will bring the following qualifications and experience:
University level education (engineering degree or related discipline) and minimum 5 year proven track record in mechanical engineering and drug delivery device development with experience of working in pharma or other closely-regulated environment, under current Good Practice (cGxP),Quality System Regulation (QSR) or similar working practices
Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices. Experience with Health Authority interactions
Demonstrable knowledge of the following: drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes and transport studies and validation
Excellent documentation, presentation and interpersonal communication skills with an excellent command of English language and proficiency in German preferable.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
