Senior Design Verification Engineer required by medical devices multinational in North Dublin for leading verification activities of Electromechanical Medical Systems.

Requirements:

• Level 8 Degree or higher in Software, Electrical, Mechanical or Biomedical engineering
• A minimum of 5 years’ experience and a proven track record in Electromechanical Medical System Verification
• Complete product or project lifecycle to submission experience
• Experience with compliance with industry recognized standards for medical device regulations
• Competent using design of experiment, data analysis and system engineering techniques
• Knowledge and use of MS Office and software tools for issue tracking and test traceability (e.g., Jira, Jama Connect)
• Strong leadership with proven track record of successful test activities in a fast-paced environment
• Hands-on ability to perform testing
• Process and detail oriented
• Excellent written and verbal communications skills to interface with multi-disciplinary teams and management

Responsibilities:

• Conceptualize complete test solutions (automation, simulation and environment) and coordinates execution of test campaigns that meet Quality & Regulatory expectations and internal development processes and procedures
• Create objective evidence and traceability through verification activities
• Conclude on verification release of candidates based on risk
• Develop and control subsystem and system verification plans
• Monitor and report on plan deliverables with metrics and dashboards during execution
• Ensure process consistency and develops best practices in verification
• Work with the various external engineering test services and measurement systems instrumentation suppliers to conduct testing on integrated products and sub modules
• Study and integrates cross-disciplinary teams (Software, Electrical, Mechanical, Systems) to arrive at an optimal test solution
• Convey information effectively through formal and informal documents, e.g., test proposals, project summaries, anomaly investigations
• Act as a Subject Matter Expert with respect to verification
• Gain consensus, leads, influences and ensures cross-discipline participation and feedback
• Provide mentoring related to design verification as necessary
• Ability to perform testing on complex electromechanical medical devices, record data per Good Documentation Practices
• Develop test methods and correct as needed
• Lead regular scrums with team and provide inputs to weekly project updates
• Assist in development of verification methods to prove requirements across multiple system and subsystem levels
• Use architecture and integration knowledge to generate optimal coverage
• Ensure data integrity, product and design traceability, clarity and accuracy of quantitative evidence across all verification deliverables
• Clear and accurate communication with multi-disciplinary project team members, stakeholders, and management
• Excellent problem solver and solution driven
• Assist in regression analysis and impact assessments for design changes tailored to product (safety and efficacy) risks
• Generate evidence for product compliance with industry recognized test standards and medical device regulations
• Perform test execution, anomalies resolution
• Propose improvements to standard operating procedures where applicable
• Assist in acquisition, development, qualification, and transfer of test tools to facilitate design test automation with: Off the shelf software products, test scripts, custom electrical test harnesses and mechanical fixtures
• Adhere to industry standard accreditation and general good laboratory practices throughout internal and external verification execution activities
• Develop innovative and best in class test techniques and methods

Hybrid work could be considered for the right candidate. 

Our client offers a range of work benefits such as Health Insurance, Bonus, Paid AL, Family healthcare and pension.

Tagged as: Manufacturing