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A Day in the Life
The Design Verification Architect will be a member of the R&D Design Assurance team, responsible for defining and implementing the overall Design Verification strategy for Patient Monitoring projects.
The Design Verification Architect will play a key role in major new product development project, working with cross-functional team members of the organization, to provide meaningful verification solutions and ensuring design meets the product requirements.
The Design Verification Architect will also be responsible for implementing continuous improvement of Design Verification methods and tools in order to optimize testing activities.
- Plan the overall Design Verification activities for the project
- Define Design Verification strategy that ensures full requirement coverage, defect detectability, and optimizes time and resources.
- Decompose the system requirements to subsystem for verification and validation
- Provide correctly configured test samples for the verification engineering team
- Conduct Design Verification readiness assessments
- Responsible for writing the Design Verification plans and summary reports
- Gather inputs. conduct impact analysis and publish the regression analysis for design changes
- Maintain and communicate overall Design Verification schedule and status, showing cross-functional dependencies, assumptions and risks
- Coordinate Design Verification efforts: system verification, clinical, HF, packaging, etc.
- Single point of contact for key stakeholders (e.g., Product Manager, Systems Engineering Quality Assurance, Regulatory Affairs)
- Establish and align expectations between Design Verification, Quality and Regulatory Affairs
- Drive continuous improvement of Design Verification methods and tools in order to optimize testing activities
- Engineering Degree (e.g. computer, industrial, biomedical, information systems, mechanical, electrical engineering)
- 5 years’ experience from medical devices or other regulated industry
- Experience in driving Design Verification activities, with a track record of productive output and completed projects
- Experience in creating test protocols and reports
- Experience in defining system tests based on system requirements
- Experience in system and subsystem level qualification planning
- Strong knowledge of sample size determination principles
- Experience working with a statistical software tool (i.e. Minitab)
- Experience with stress testing, including accelerated aging, vibration, transportation testing, EMC, etc.
- Excellent English
- Good presentation and reporting skills
- Fast and agile adjustment to changes
Nice to have
- Experience working in the medical device industry and familiarity with design control processes as defined in ISO 13485 and FDA 21 CFR Part 820
- Knowledge in Medical Device standards, e.g. IEC 60601
- Knowledge of Six Sigma or Lean techniques
Is this the position you were waiting for? Then please apply directly via the apply button!