System Design Engineer # JN -032021-61673
Title : System Design Engineer
Location : Princeton, NJ
Duration : 12 months contract
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Participate in the entire system or software development life cycle. Upon establishment of the requirements baseline, the focus is shifted towards the management of the requirements specification and verifying the fulfillment of all requirements.
- Participate in system-related tasks such as but not limited to: requirements analysis, product test and evaluation, system Verification & Validation (V&V), design reviews and design control documentation.
- Lead requirements analysis and verification, ensuring that requirement statements are complete, consistent, concise, comprehensible, traceable, feasible, unambiguous, and verifiable, and that they conform to standards.
- Manage requirements traceability information with test data and track requirements status.
- Devise strategy and methodology for system / product level characterization and formal design verification of complex systems; document through formal design reviews
- Develop design verification protocol for system / product level requirements, conduct design verification testing; collect, organize, analyze and document test results.
- Develop design validation protocols and conduct validation studies against the user needs and intended product use.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Participate and/or co-lead cross-functional teams in support of organizational goals.
- Understand and comply with applicable EHS policies, procedures, rules and regulations.
- Responsible for implementing and maintaining the effectiveness of the Quality System.
- Bachelor's Degree, preferably engineering or Computer Science or equivalent experience desired. Advanced Degree preferred.
- Typically requires 3-5 years of relevant experience
- Experience devising tests, creating design V&V protocols and performing system verifications and validations
- Knowledge of general engineering / science principals and/or laboratory skills
- Experience in Medical Device industry preferred
- Knowledge of defined development process that is consistent with industry standards (e.g. ISO, FDA, CMMI, design control standards or requirements).
- Knowledge of contemporary design control and risk management practices.
- Understanding of electro-mechanical, software, mathematical, chemical or biochemical processes in diagnostic systems.