Senior Systems Engineer
Our client, a global medical device manufacturing organization is seeking an experienced engineering professional to join their team, located in the SF Bay Area to work in the capacity of Senior Systems Engineer. The chosen candidate will have complete understanding of a wide application of technical principles, theories and concepts in the field of Engineering as demonstrated by significant industry experience and accomplishments/accolades. You will be an expert in the application of systems engineering techniques such as Requirements synthesis/management/traceability, Risk Management (ISO 14971), Verification and Validation, Product Architecting and Lifecycle Management. Additionally, you will provide technical support to a wide range of problems as pertaining to specific programs and projects. She/he will act as Technical Lead on a mid to high complexity program(s), accountable for identification, communication and mitigation/implementation program technical risks to Executive Level management. The ideal candidate will be a seasoned Systems Engineer with architecture experience in the field of flow cytometry coupled with strong leadership skills with a proven track record of leading a large team, centralized and decentralized and cross-functional.
*Act as Technical Leader on project/program needs based on the lifecycle phase (cradle to grave).
* Exercise judgement within generally defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
* Use disciplined work methodologies utilizing scientific and statistical methods (6 Sigma) in resolving problems, devising tests and setting specifications.
* Supervise and manage the work of other Engineers assigned to the program.
* Understand complex electro-mechanical/optical systems, their interactions with Reagents, theory of operations details and spend hands-on time in the lab as necessary.
Best Industry ? Biotechnology, IVD or Medical Device
Best Department ? Engineering
Bachelor's Degree in Engineering or BME/Bioengineeringdegrees preferred. MS Degree is preferred. SSBB or INCOSE CSEP Certification is strongly preferred. PMP certification is a plus.
12 - 15 years of experience in medical device/IVD industry is required.
5 years industry experience in the field of Flow Cytometry is preferred.
Experience and Proficiency with Product Architecting (Functional/Physical) and Platform (integral/modular) Creation Tools is required. Candidates without this experience will not be considered.
Proficiency in use of ISO 14971 Risk Management methodologies is required.
Knowledge in multiple areas related to cytometry or cell analysis such as signal processing, embedded systems, electronics and/or software.
Knowledge of fluidics, optics, and/or assay reagents is highly desirable.
Expertise in Planning, Prioritization and Organization activities related to Systems Engineering deliverables and it's dependencies on cross-functional deliverables.
Experience leading Instrument/device characterization and Human Factors Assessments.
Proficient in implementation of Traceability tools such as DOORS, Team Foundation Server (TFS).
Experience leading large R&D teams on Core Teams that includes cross functional core team members at senior management levels is mandatory in this role.
Knowledge of system stress analysis and hazards analysis is required.
Experience in experimental techniques, statistical analysis & engineering investigation techniques is required.
Experience in developing and executing system integration as V&V engineer or performance characterization test procedures through virtual simulation and real test scenarios is required.
C-Level communications skills are required.
Experience leading FDA/Regulatory submissions from and R&D perspective is required.
Participation on Standards Committees (e.g. IEC, AAMI) is a plus.
Strong communications skills (Verbal, written and presentation) are required.
Relevant Patents and Publications are a plus
Up to 20% Domestic Travel required.
US Citizens or Green Card holders only apply. No H1b visa sponsorship will be offered with this position.