Our client is seeking an experienced Systems Engineering professional to work in the capacity of Senior Manager of Systems Engineering to work at their offices, located in San Jose, CA. 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. The ideal candidate 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. You will provide technical support to a wide range of problems as pertaining to specific programs and projects.
*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.
* 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 (Six 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, Medical Device, IVD
Best Department ? Engineering
Bachelor?s Degree in in Electrical, Mechanical, Bioengineering are preferred. MSDegree in Engineering highly preferred. Six Sigma Black Belt, INCOSE CSEP Certification or PMP certification is preferred.
15+ years of experience in medical device/IVD industry is required.
5years of industry experience in the field of Flow Cytometry is strongly preferred.
Experience and Proficiency with Product Architecting (Functional/Physical) and Platform (integral/modular) Creation Tools is required.
Proficiency in use of ISO14971Risk Management methodologies is required.
Expertise in Planning, Prioritization and Organization activities related to Systems Engineering deliverables and it?s dependencies on cross-functional deliverables is required.
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 required.
Experience leading FDA/Regulatory submissions from and R&D perspective is required.
Relevant Patents and Publications are preferred.
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.
Experience in Flow Cytometry Customer environment (clinical/research/academia/pharma organizations)
Experience in developing and executing system integration as V&V engineer or performance characterization test procedures through virtual simulation and real test scenarios is preferred.
Up to 15% Domestic TravelRequired.
US Citizens or Green Card holders only apply. No H1b visa sponsorship will be offered with this position.