Sr. Systems Engineer
DivIHN Integration Inc
Pleasanton, CA
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
Duration: 7 Months
Location: Pleasanton, CA
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Description:
Skills:
- Significant experience in software requirements development
- Ability to work in a geographically diverse environment
- Ability to work within a team and as an individual contributor/team lead in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes and meets deadlines in timely manner
- Ability to maintain regular and predictable attendance
- Experience working in an Agile lifecycle methodology
- Experience as a Software Systems Engineer in a Medical Device company
- Experience requirements management tool
- Experience with FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 62304
Education: Bachelor's degree required
Duties:
- Serve as a Software Systems Engineer Individual Contributor and Team Lead to deliver:
- Requirements Elicitation
- Requirements decomposition/traceability
- dFMEAs
- SysML/SW Architecture
- Creating Development Plans
- Trade-Off Studies
- Trace Matrix
- Lead technical software design reviews for deliverables
- Own and author of internal design documentation with high level of polish for consumption by other engineers and business partners
- Validate the efficacy and value of implemented design patterns and documentation and continuously improve
- Self-directed coordination of implementation projects, tasks, device documentation and cross training of coworkers
- Responsible for staying abreast of emerging developments in infrastructure and software technologies and making recommendations as appropriate
- Med device exp. required. Potential to extend for right candidate but no guarantee. Start asap if onboarding requirements met. Prefer local candidates over others.
Years Experience: 5 years of systems engineering experience
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.
Agile, EU MDR, FDA 21 CFR 820