System Engineer - Design Controls
Location : Ramsey NJ US 07446
Job Type : Temp/Contract
Reference Code : 19649-BZ1
Compensation : open
Hours : Full Time
Required Years of Experience : 10
Required Education : BS in Systems, Biomedical, Electrical, or Software Engineering
Travel : No
Relocation : No
Job Industry : Engineering
Job Description :
- Contract position for a Systems Engineer who will develop and maintain technical documentation related to the Design History File of complex electro-mechanical software driven medical devices.
- Lead and participate in cross-functional teams that focus on requirements engineering, risk management, verification/validation, and reliability assurance.
- Ensure that remediation activities are compliant with internal development processes and regulatory requirements specifically 21 CFR 820.30.
- Develop and maintain Design Inputs documentation, including system-level requirements, product specifications, traceability matrices, and test to specifications.
- Develop and maintain Risk Management documentation, including plans, hazard identification, hazard analysis, design failure mode and effects analysis (DFMEA), and reports.
- Develop and implement system-level design verification and validation concepts.
- Develop and implement system-level reliability assurance concepts, including accelerated life testing.
Required Qualifications :
- BS in Systems, Biomedical, Electrical, or Software Engineering with 10+ years of related experience, or MS or PhD in Systems, Biomedical, Electrical, or Software Engineering with 7+ years of related experience.
- Knowledge of requirements development, traceability, and allocation.
- Knowledge of medical device risk management, including ISO 14971:2012.
- Knowledge of design verification and validation concepts, including the planning and execution of system-level testing of medical devices.
- Knowledge of reliability assurance, with experience in reliability allocation, prediction models, and accelerated life testing at a component and system level.
- Medical Device experience including thorough understanding of Design Controls (21 CFR 820.30).
- Working knowledge of FDA and International Standards requirements as related to capital equipment.
- Experience with Requirements Management Tools (such as CaliberRM).
Contact: Bill Zukowsky