BD (Becton, Dickinson and Company) Staff Engineer - Systems Engineering in San Jose, California
Job Description Summary
This position will be in the Systems Engineering Team, reporting to a Manager in the Systems Development Group. This is a Manager Level position on the Technical Leadership Career Track.
The Staff Engineer must have experience working with Clinical IVD/Medical device platforms with an intricate understanding of Product Development/Design Control/Regulatory strategy implications for successful and timely launch of Clinical products. We are looking for a Technical Leader who can work collaboratively across functional lines, within and outside of R&D. This person will own the design aspects of the platform, support audits post commercial launch while concurrently supporting the expectations of future instrument/assay launches (staggered launches) in different geographical regions worldwide. Successful talent will have the opportunity to grow along the Technical Track to potentially achieve positions to the level of Principal Engineer (Sr. Director level position on Technical track).
The Staff Systems Engineer will have complete understanding of a wide application of technical principles, theories and concepts in the field of Engineering. She/He will be proficient in the application of Systems Engineering techniques such as Requirementssynthesis/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, accountable for identification, communication andmitigation/implementationprogram technical risks. 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 judgment 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 in resolving problems, devising tests and setting specifications. May supervise the work of other junior Engineers assigned to the program. We are looking for a motivated Technical Leader who will need to understand complexelectro-mechanical/opticalsystems, theory of operations details and spend hands-on time in the lab, as and when needed.
Education and Experience:
Minimum of a Bachelor’s degree in the field of Electrical/ Electronics/ Mechanical/ Biomedical Engineering. 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 8 years of experience in clinical medical device/IVD projects.
Minimum of 1 year experience developing and executing integration or test procedures as part of New Product Development or Sustaining Engineering projects.
Proficiency in use of ISO 14971 Risk Management methodologies.
Experience leading Instrument/device characterization and Human Factors Assessments.
Proficient in implementation of Traceability tools such as DOORS, Team Foundation Server (TFS).
Technical Leadership Experience required. Excellent Oral, Written and Presentation Skills.
Experience supporting FDA/Regulatory submissions.
Previous Design Control/Design for Six Sigma experience.
INCOSE CSEP Certification.
Knowledge in one or more 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 also helpful.
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 (DMAIC/six sigma green belt preferred).
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