Permanent Position
Lake Forest, IL
Description for Senior Systems Engineer – Verification & Validation: Seeking a hands-on senior-level Systems Engineer with strong technical background and relevant experience in verification and validation (V&V) of consumables, devices and drug/device combination products. Follows product development process and requirements traceability for FDA regulated medical devices and apply FDA 21 CFR Part 820 and ISO standards governing design verification and validation medical devices.
Responsibilities for Senior Systems Engineer –
Verification & Validation:
Systems engineering leadership
- Leads
V&V activities related to new product development and on-market
products
- Review,
assess, and support mitigation of verification and validation technical
risks
- Tracks
to closure of systems verification/validation issues and ensures
documentation
Product definition
- Support
and provide input to development of user needs and product requirements
- Provide
content for the Design Input Reviews as required by the project teams
Product risk management
- Creates
tracing to verification and validation protocols/reports to cover risk
controls in the Hazards Analysis
- Executes
to test plans and provides data for reports in a medical devices industry,
including tracking of system issues based on risk analysis for appropriate
disposition
Product requirements
- Reviews
user needs, design inputs and design specifications for verification and
validation applicability
- Participates in
product requirements flow down tracing activities as applicable to
verification and validation
Verification and validation
- Plans
and executes system verification / validation tasks
- Creates
tracing of verification coverage of design inputs/design specifications
and validation coverage of user needs and hazards as appropriate
- Leads
design verification & validation readiness and exit reviews
Requirements for Senior Systems Engineer – Verification
& Validation:
1. With Bachelor’s 6-10 years of systems
engineering experience or substantial equivalent function. With Master’s 0-3
years experience.
2. Advanced ability
to develop test plans, protocols and to execute verification and
validation (V&V) tests to ensure that product designs meet design
requirements and intended use
3. Advanced
experience utilizing engineering product development methodologies
including validation of user needs by interacting with end users to gather data
4. Aptitude for
applying medical knowledge and human factors considerations to set up or
assess workflows, interfaces, or interactions of users for test derivation
5. Possess strong
interpersonal skills to work across department and site boundaries and
supporting project teams
through cross-functional interactions
through cross-functional interactions
6. Experience with medical
devices and the regulations related to medical devices (FDA/ISO) desired
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