Beschreibung
A fantastic opportunity has arisen for an Embedded Software Professional to make a real mark of difference for a global Medical Device company. Using your expertise you will design the architecture for introducing connectivity features/embedded software within a range of next generation medical devices. You will take the product from concept/ idea generation phase right through to commercialisation. You will be working with a large range of combination medical devices such as pen injectors, autoinjectors etc.Responsibilities
- Lead technical development activities for embedded software components of medical devices used in combination products, eg auto-injectors, pumps.
- Specify requirements (DIR) of software components and define architecture for future platforms, including liaison with teams developing Digital Ecosystem.
- Working with human factors engineers to define the appropriate HMI and activities.
- Collaborate with electronics experts to ensure appropriate hardware defined for software requirements.
- Manage suppliers in the detailed software design, coding and documentation with consideration of medical device classification.
- Ensuring fail-safe operation through architectural design as well as real time error checking to prevent logical, numerical or HMI errors.
- Applying security protocols for wireless communication to pair and operate components of the system.
- Ensuring data security and integrity with consideration of FDA CFR Part 11.
- Planning and reviewing the verification and validation of the software to ensure safe and secure operation with attention to hardware and operating system environment and versions.
- Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems.
- Ensure device design development in compliance with the regulations and delivered to a high quality.
- Root cause analysis of out-of-specification product and develop robust solutions to prevent re-occurrence.
Requirements:
- An ideal candidate would have at least 8 years of experience in software development for medical devices ideally with main focus on combination devices (parenterals, drug delivery devices) or small devices.
- Excellent technical writing skills (e.g., Design Controls, DHF)
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)and of combination products (US) and standards
- General understanding of Human Factors Engineering and Risk management
- Excellent project leading experience, ability to communicate well of your ideas and work closely with suppliers to make the vision into a reality.
- Experience leading a product from conception to commercialisation.
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Michael Bailey International is acting as an Employment Business in relation to this vacancy.