Sr. Systems Engineer
DivIHN Integration Inc, Pleasanton, CA, United States
DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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Title: Sr. Systems Engineer Medical Devices
Location: Pleasanton, CA
Duration: 1 Year
Description:
WHAT YOU'LL 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 on-site in Pleasanton, CA, the primary responsibilities include systems integration, formal verification, following design change control process, including supporting on-market products.
The individual will be expected to provide hands-on 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 (62304, 60601, 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 YOU'LL BRING
Required
Bachelor's 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 fast-paced, changing environment.
Preferred
Master's 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 Mid-West 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.