Sr Systems Engineer Medical Devices

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Title: Sr. Systems Engineer Medical Devices

Location: Pleasanton CA

Duration: 1 Year

Description:

WHAT YOULL DO

The Senior Systems Engineer (Contract) will be accountable for supporting the delivery of systems engineering tasks for significant portions of programs including integration of medical device components into a single system that include wired and wireless technologies.

Working onsite in Pleasanton CA the primary responsibilities include systems integration formal verification following design change control process including supporting onmarket products.

The individual will be expected to provide handson execution and work with other team members from a wide range of functions and/or geographical locations. Communicates with the other engineering personnel to coordinate the interrelated design and assure project completion.

RESPONSIBILITIES

Executes system engineering testing to verify systems functionality including software and system components.

o Drives and records configuration of system at integration points.

o Supports system design change control process.

o Supports systems integration / verification plan and report.

o Generates Systems test protocols reports.

o Executes system verification testing.

o Identifies and escalates risks / system anomalies with existing requirements.

o Evaluates/analyzes requirements for coherence and completeness and clarifies ambiguous requirements.

o Ensures tracing from requirements and risk to test protocols and reports.

Working experience with Requirements Managements tools e.g. DOORS JIRA etc.

o Experience in understanding medical device standards (etc.) a plus.

Complies with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments.

Cooperative communications and collaboration with all levels of employees customers contractors and vendors.

Anticipated business travel around 10%.

EDUCATION AND EXPERIENCE YOULL BRING

Required

Bachelors degree in engineering and/or Science with 5 years of experience in developing highly engineered products (at least 3 years in medical/diagnostics products) or an equivalent combination of education and experience.

Possesses systems engineering experience spanning the entire product lifecycle including proficient use of systems engineering tools (e.g. requirements management change control etc.).

Systems engineering experience (at least 3 years) in a highly regulated industry.

Excellent verbal and written communication skills with ability to communicate effectively with Core Team members.

Ability to work within a team and as an individual contributor in a fastpaced changing environment.

Preferred

Masters degree in engineering (Computer Electrical Computer Systems or Software) Computer Science or related discipline.

Medical device experience specifically supporting heart failure and/or cardiovascular systems.

About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the MidWest and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.