Systems Engineer - W2 -Medical Device

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.