Subject Matter Expert (SME) for Software Development - Zurich MedTech, 'Sexy' product - English essential - permanent position
Based in Zurich, our client is a small, developer and manufacturer of a Class III medical device doing well in Europe and ramping up production for imminent release into the USA.
This particular position is a key role in the company with responsibility for everything Software related, ranging from hands on (Software) development, troubleshooting, verification and validation, change management, an acting as the technical Subject matter expert for Quality, Regulatory, and Development areas within the Business. It is also a replacement role with the incumbent leaving in September but with company commitment for the new person to start as early as July or August.
Being an electromechanical device, a background in areas such as electrical engineering, biomedical engineering, physics, software engineering, even mechanical engineering/Materials science are all relevant provided there is strong Software development expertise as part of that, with an expected seniority of 5 years+ and with specifically Medical Devices experience as part of that.
A good working knowledge of relevant ISO standards (ISO 13485, ISO 62304, FDA equivalents) is desirable, while fluent English is essential both as the local spoken language but also for documentation purposes, which are an important part of this role.
This is a terrific opportunity to join a company at the ground level and during a strong growth cycle and help deliver products to market that significantly improve a patient's quality of life.
If this sounds interesting, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 817, and email him your resume in WORD format to firstname.lastname@example.org including Zeugnisse / Employment records and scanned copies of training certifications.
KEY WORDS: Feasibility, Concept, Design, Development, Validation, Verification, Risk Management, Compliance, electromechanical, hardware, software, product support, documentation, technical, Design Control, Manufacturing, Change control, Medical Devices, German, English, ISO 13485, IEC 62304, code development, code review, Integrated Development Environments, software release management, build servers, software test platforms, Engineering, Production, Medical Device jobs, Nonstop recruitment.
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