We are currently working with a ground breaking medical device manufacturing company, who are in a state of growth and therefore looking to appoint a Requirements Engineer to their team based at their HQ site near Warwick. As an Embedded Software Engineer, your projects will be diverse in nature working on both existing and developing medical device technologies.
- To contribute significantly to the creation and evolution of the software content of the Company’s products
- Satisfying the needs of product development and assurance, compliant with applicable medical device regulations and standards
Essential Candidate Experience:
- Experience in requirements capture in a regulated industry such as Medical devices, Defence, Aerospace, Automotive, Oil & Gas.
- Please note that we are not looking for extensive experience for this position, hence the salary range on offer.
- Updating and maintaining the V-model used to define and verify essential characteristics of our clients dialysis products including SC+ machine, consumables, accessories and connectivity solutions (current and future products)
- Formalising requirement specifications, trace reports, verification test specifications and verification test summary documentation.
- Analysing design changes and performing inspections to update verification evidence.
- Supporting the Systems Architect, Lead Requirements Engineer and all associated teams with V-model updates and queries.
- Review, maintain and evolve requirements and tests at all of the following levels:
o User Needs
o Functional / Application (Modal)
- Collaborate closely with key areas of the business including Commercial to ensure all input and product feedback is captured and processed accordingly.
- Ensure testability of all requirements to facilitate effective verification.
- Support other engineers in their own maintenance of requirements.
- Manage detailed tracing of requirements and tests.
- Support improved use of Quanta’s V-model Management tools to improve:
o Quality of existing requirements and tests - e.g. addressing gaps, inconsistencies, weaknesses, complex items that need to be de-constructed and so on.
o Compliance with applicable standards and acknowledged definitions of good requirements and test management practice
o Standardization of language and terms
o Formality of expression to minimize ambiguity and misunderstanding
o Use and configuration of tool customization capabilities
o Quality of V-model audit trails
o Coordination of V-model documentation across;
- Multiple variants of given design (e.g. Internationalization options)
- Multiple versions in the life of a given design
- Multiple designs based on common platform
Requirements / Qualifications
- Strong educational background; related Engineering, Science or BioMed Degree
- Experience working to Quality Systems in line with EN ISO 9001, BS EN 14971, BSENO ISO 13485 is also desirable.
- Quality Focused, able to identify issues and propose appropriate solutions
- Experience of;
o Requirements engineering and use of software tools to manage complex bodies of requirements and traceability material
o Verification and validation activities on whole products or sub-systems
o Whole product life cycle for complex multi-technology systems
- Strong written communication skills including;
o Structured use of natural language
o Mathematical Expression
o Concise written communication
Appreciation for, or experience across, the full spectrum of systems, mechanical electronic and software engineering
- Strong attention to detail and record keeping
- Strong interpersonal skills