Design Verification Engineer
Location : Ramsey NJ US 07446
Job Type : Temp/Contract
Reference Code : 19647-BZ1
Compensation : open
Hours : Full Time
Required Years of Experience : 7
Required Education : BS Biomedical, Electrical, or Software Engineering
Travel : No
Relocation : No
Job Industry : Engineering
Job Description :
- Contract position for a Design Verification Engineer to support an effort to ensure that R&D design and verification practices for medical devices meet the Code of Federal Regulations; specifically 21 CFR Part 820 - Subpart C to demonstrate the design integrity of complex software driven life support devices.
- Development and / or remediation of technical documentation that comprise the device Design History File(s) (DHFs).
- Development and validation of improved test methods and/or test fixtures.
- Develop requirements engineering, device verification/validation testing and test method validation.
- Maintain compliance with internal development processes and regulatory requirements.
- Upgrade key validation test methods and test fixtures.
- Design Test Method Validation (TMV) studies to qualify test methodologies & fixtures.
- Classify and separate design input vs. output requirements in derived requirements documents.
- Evaluate the potential restructuring and release of algorithmic "white papers".
- Update and maintain proper design output documentation: including low level software implementation requirements (white paper design outputs), traceability matrices, and output verification testing.
- Develop and implement system-level design verification and validation concepts.
Required Qualifications :
- BS Biomedical, Electrical, or Software Engineering with 7+ years of related experience, or MS Biomedical, Electrical, or Software Engineering with 5+ years of related experience.
- Experience in leadership role in the remediation process.
- Project management skills such as scheduling (Gantts), resourcing and progress reporting.
- Knowledge of design verification and validation concepts, including the planning and execution of system-level testing of medical devices.
- Medical Device experience, including thorough understanding of Design Control and Risk Management.
- Knowledge of requirements development, classification, traceability, and the implementation process.
- Working knowledge of FDA and International Standards requirements pertaining to capital equipment.
- Knowledge of medical device risk management, including ISO 14971:2012.
- Experience with Requirements Management Tools (i.e.: CaliberRM).
- Experience with Quality Management Document Control Systems (i.e.: TrackWise).
Contact: Bill Zukowsky