Careers that Change Lives
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
This engineering position requires high level technical and leadership skills to advance the development of innovative system solutions in support of the business roadmap. We are looking for individuals who have a background in systems engineering and are passionate about system maturity/reliability, integration, characterization, verification, and validation. The engineer will apply technical principles, theories, and new concepts to collaboratively solve technical problems. Under direction of the V&V Manager, this position is responsible for leading the design, development, documentation and execution of system verification & validation plans, schedules, test protocols and reports to ensure products meet published specifications and are compliant with Quality System Regulations.
A Day in the Life
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
This engineering position requires high level technical and leadership skills to advance the development of innovative system solutions in support of the business roadmap. We are looking for individuals who have a background in systems engineering and are passionate about system maturity/reliability, integration, characterization, verification, and validation. The engineer will apply technical principles, theories, and new concepts to collaboratively solve technical problems. Under direction of the V&V Manager, this position is responsible for leading the design, development, documentation and execution of system verification & validation plans, schedules, test protocols and reports to ensure products meet published specifications and are compliant with Quality System Regulations.
A Day in the Life
- Work with peer systems engineer(s) during development of user needs & intended uses and design input requirements to ensure they are validate-able and verifiable respectively.
- Develops approach & authors Verification & Validation Plan, documenting scope of system V&V effort, while working with product/functional engineers to ensure proper and complete coverage.
- Authors Integration Plan and corresponding test protocols during design development phase of project to progressively and predictably build design maturity. Executes tests per defined Integration Plan.
- Works with various stakeholders to understand scope of characterization needed, including need to understand design capability. Executes system characterization efforts.
- Influence product/component integration and characterization plans in order to assist in incremental system maturity. Works with engineers cross-functionally (different departments) to achieve results.
- Authors design verification and design validation protocols and reports. Executes system verification and validation activities.
- Works with Human Factors engineer to ensure inclusion, tracing and proper coverage of applicable user needs in their summative usability study.
- Works with Clinical to ensure inclusion, tracing and proper coverage of applicable intended uses in their pre-clinical or clinical study.
- Plan and execute Test Method and Non-product validations (spreadsheet, software, etc.), and equipment and tooling qualification, per project needs.
- Monitors progress of assigned tasks to defined project schedule.
- Monitors and mentors Associate System Engineers as required.
- Produce high quality deliverables while complying with relevant SOP.
- Authors Summary report and other relevant inputs for submission by Regulatory Affairs to regulatory agencies in support of market release review and approval.
- Travel requirement: Less than 10%
Minimum Qualification
- Overall 8+ years of experience
- 4+ years of experience in medical device product development or 2 years of experience with MS degree
- Two (2) or more years of experience in Verification and Validation of complex software and hardware systems
Nice to Haves
- Excellent critical thinking and problem solving skills, including application of structured problem solving methods and tools
- Strong written and oral communication skills, including the ability to clearly and concisely summarize complex technical concepts and problems
- Strong collaboration and influence skills
- Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications
- Experience with automated and/or manual software tests
- Experience in medical devices or other regulated industry
- Experience working with IEC 62304
- Knowledge of Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices
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