BD (Becton, Dickinson and Company) Sr. Staff Engineer, Systems Engineering in San Jose, California
Job Description Summary
This challenging position will be in the Systems Engineering Functional Team. This is a Senior Manager Level position on the Technical Leadership Career Track. Open to considering stellar candidates for Principal Engineering (Director level) position.
The Systems Engineering Leader 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. She/he 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. She/He 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 Systems Engineer is intended to be a versatile position capable of acting as Technical Leader on project/program needs based on the lifecycle phase (cradle to grave). This person will be expected to exercise judgement within generally defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. The person in this position will use disciplined work methodologies utilizing scientific and statistical methods (6 sigma) in resolving problems, devising tests and setting specifications. She/he supervises the work of other Engineers assigned to the program. We are looking for an action oriented Technical Leader who will need to understand complex electro-mechanical/optical systems, their interactions with Reagents, theory of operations details and spend hands-on time in the lab as necessary.
Education and Experience:
Minimum of a Bachelor’s degree in the field Engineering. BME/Bioengineering degrees preferred. Graduate degree in Engineering highly preferred.
Experience and Proficiency with Product Architecting (Functional/Physical) and Platform (integral/modular) Creation Tools. Candidates without this experience will not be considered.
Minimum of 15 years of experience in medical device/IVD industry.
Minimum of 5 years industry experience in the field of Flow Cytometry preferred.
Proficiency in use of ISO 14971 Risk Management methodologies.
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.
Excellent Oral, Written and Presentation Skills and Comfort-level presenting at V.P./G.M. levels.
Experience leading FDA/Regulatory submissions from and R&D perspective.
Participation on Standards Committees (e.g. IEC, AAMI).
Relevant Patents and Publications.
Six Sigma Black Belt.
INCOSE CSEP Certification.
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 working on cross functional teams and has the capability of providing coordination among groups or functions.
Knowledge of systems stress analysis and hazards analysis.
Experience in experimental techniques, statistical analysis & engineering investigation techniques.
Experience in developing and executing system integration as V&V engineer or performance characterization test procedures through virtual simulation and real test scenarios.
Primary Work LocationUSA CA - San Jose
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status