Job Description

Job Title - Sr Prin Systems Engineer - Exempt

Job Location – (Moorpark or Northridge) California

Duration – 12 Months

Job Description -

1. ‎Experience with Requirements Management

2. Experience with Medical Device Software (at least 5 years)

3. Medical Device experience is highly preferred

• Candidate will have experience in Medical Device product development.
• Client looking for a versatile engineer that can execute a varity of Systems Engineering tasks with an expansion into Software design history file management.
• The tasks included: Requirements Management, Verification Trace Matrices, Protocol Creation, Test Execution, and Report Creation. An understanding of Medical Device quality systems is ideal, with experience in Design Verification and Validation.
• I would like someone that can start with a list of requirements, draft a test protocol to verify each requirement, execute the testing, and write the final report.
• Additionally,Client would like someone that has experience with the Medical Device Software Lifecycle , specifically with the IEC 62304 Software Lifecyle Standard.
• CLient not looking for someone to develop software, just experience with it such that they can manage our software design history files
• Experience with JAMA software would be a plus

Responsibilities may include the following and other duties may be assigned.

• Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems.
• Analyses are performed at all levels of total system product to include:
• concept, design, fabrication, test, installation, operation, maintenance and disposal.
• Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.
• Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

TECHNICAL SPECIALIST CAREER STREAM:

• An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies.
• Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

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