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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

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