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Sean McCarthy
Life Science

[email protected]
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Senior System Design Verification & Validation Engineer

Reference:SMC33621 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Plan for verification procedures execution within internal and external laboratories. Propose partnerships with external laboratories or service providers (execution, certification, consulting).

Develop and control verification plans for complex electromechanical systems and subsystems. Monitor and report continuously on plans deliverables during execution with dashboards and present results in technical reviews. PROJECT MANAGEMENT

Ensure data integrity, traceability, clarity and accuracy across all verification documents and verification activities objective evidence. DOCUMENTATION

Communicate with clarity and accuracy on regular basis with internal SMEs (ME, EE and SW) and external stakeholders PM / QA / RA / agencies on verification progress (dashboard) and outcome (design reviews). COMMUNICATION

Ensure verification activities comply with US / EU regulations and medical industry standard. Plan and control product compliance testing by external certified laboratories (electrical safety, cybersecurity, etc…). COMPLIANCE

Support regression analysis and provide impact assessment for change requests based on product knowledge and existing verification evidence. Prioritize remediation of traceability gaps through risk assessment. Lead change controls and review design requirements testability. DESIGN CONTROLS

Develop and maintain verification procedures and protocols to ensure successful integration of: 1- software and hardware together (subsystem verification) and 2- subsystems and accessories (system verification). Develop a sustainable design requirements coverage that fits well with evidence generated by other qualification activities (reliability, validation, human factors, etc…). SYSTEM ENGINEERING

Create objective evidence and traceability through verification activities. Conclude on verification release status of candidates based on risk. PROCESS

Optimise verification activities by grouping and ordering verification procedures and protocols. Define high-level acceptance criteria and methods/techniques depending on risks and strategic objectives. DESIGN OF EXPERIMENT

Plan acquisition, development and qualification of verification test setups & harnesses. EQUIPMENT & TOOLING

Define and justify to internal/external stakeholders appropriate sample size for tests. Plan and secure access to required candidates. STATISTICS

Develop and use best in class verification techniques applicable to medical industry (software simulations, HW/SW integration, partition equivalence, automation). Optimise and continuously improve verification procedures and protocols in adherence with design change control best practices. INNOVATION

Expert in one or more of the following verification specialities: software verification, test automation, PCBAs or firmware verification, system reliability, system compliance, stress testing, sub-systems integration. ENGINEERING

Job Requirements:

Experience and a proven track record in electromechanical medical system verification:

  • Over a complete product or project lifecycle (concept, development, qualification, submission),
  • In compliance with industry standards and regulations.
  • Using verification engineering techniques and system engineering knowledge.

MS or PhD in software, mechatronics or biomedical engineering.

  • Experience leading medical system design verification,
  • Experience with electromechanical testing & R&D environment,
  • Experience with regulatory submission.

ISTQB certification or equivalent required

If interested in this opportunity please contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.