Instrument Software Development Engineer

Proclinical is seeking an Instrument Software Development Engineer to be based in Nyon, Switzerland on a contract basis. The Software Development Engineer is responsible for the System design, verification and validation activities associated with the development of complex software controlled electromechanical medical devices.

Responsibilities will include the definition and development of medical device requirements as well as defining and implementing system and subsystem level verification and validation testing of embedded microprocessor-based medical device products. This includes collaborating with engineers to design systems for testability, defining testing requirements, creating test plans and strategy, creating and overseeing test execution and reporting

Job Responsibilties:

• Lead the design and development of clearly defined interfaces bridging the gaps between electrical, mechanical and software disciplines.
• Lead and support Design Reviews with a focus on Requirements definition and V&V activities.
• Lead and support risk management activities, including FMEA's, to ensure robust and reliable designs
• Lead, develop and implement design characterization, DOE's and design verification strategies for efficient, complete and robust testing through report completion and anomaly resolution or independently perform tolerance, error budget or other design analysis by extending or adapting existing methodologies.
• Reviews engineering specifications and drawings, proposing design modifications to improve system design within cost and other performance requirements.
• Responsible for the methods and tools for automated system testing.
• Work with stakeholders to identify, define and document constraints and assumptions for the development and testing of medical devices.
• Use Risk management tools and techniques to develop solutions.
• Perform any other duties as reasonably requested from the Company from time to time.
• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements.

Skills and Requirements:

• Bachelor in Software Engineering / computer science
• Expert understanding of Medical Device / IVD Instrument Life Cycle
• Strong Experience in documenting medical device requirements (design inputs) with accuracy and testing outputs
• Experience in development of complex, sophisticated, software controlled electromechanical medical devices and software validation activities
• Experience in life sciences, bioengineering and/or medical device design, including bringing regulated products from development through to commercial readiness
• Strong software development background
• Strong understanding of medical device regulations including ISO, FDA GMP and design controls
• Strong working knowledge of Electromechanical Design, Requirements Definition and V&V activities
• Extensive Experience in a GMP/GLP environment
• Exposure to Internal and external audit
• Strong Communication Skills
• Must be capable of working to tight timelines, with agility to shift focus when required
• Excellent presentation and report writing skills
• Evidence of time management and prioritisation skills
• Excellent attention to detail
• Proficiency in English,
• French is an asset

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Hugh Pickerill on +44 203 854 1079 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.