This position will be in the Systems Engineering Team. This is a position on the Technical Leadership Career Track. This person will be the Lead Systems Engineer on the Next Generation High Throughput Sampler (HTS) Project.
The next generation HTS instrument solution will be a modular accessory to the product derivatives emerging from the BD Bioscience - Next Generation Instrument (Sorter/Analyzer) platform. We are looking for a Technical Leader who can driveproduct development from cradle phase through commercial launch, in a high-matrix, cross-organization environment under stringent program timelines.
- The Staff Engineer will have complete understanding of a wide application of technical principles, theories and concepts in the field of Engineering.
- She/He will work with Commercial/Platform counterparts to drive, refine and subsequently capture Customer (marketing) requirements
- She/He will work with external R&D partner(s) and/or Manufacturing Partners to design/develop the instrument that integrates with next generation Sorter/Analyzer instruments. This includes definition of the instrument architecture and standard interfaces that would assure its integration with Sorter/Analyzer instruments.
- Lead all System (HTS sampler) characterization activities.
- She/He will develop User Work flows using System Modeling tools and techniques.
- She/He will be proficient 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 HTS project, accountable for identification, communication and mitigation/implementation of program technical risks.
- She/he will ensure the product requirements are defined/maintained and the lower-level functional design teams built and deliver to these requirements.
- 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 high-energy, motivated Technical Leader who will need to understand complex electro-mechanical/optical systems, theory of operations details and spend hands-on time in the lab to support high-impact project issues.
Education and Experience:
- Minimum of a Bachelor’s degree in the field of Electrical/ Electronics/ Mechanical/ Biomedical Engineering. Graduate degree in Engineering highly preferred.
- Minimum of 8years of experience in clinical-medical device/IVD projects.
- Experience and Proficiency with Product Architecting (Functional/Physical) and Platform (integral/modular) Creation Tools.
- Proficiency in use of ISO 14971 Risk Management methodologies.
- Experience leading Instrument/device characterization and Human Factors Assessments. Experience with Formative/Summative/Clinical Studies is an asset.
- Proficient in implementation of Traceability tools such as DOORS, Team Foundation Server (TFS).
- Technical Leadership Experiencerequired. Excellent Presentation & Influencing Skills.
- Experience supporting FDA/Regulatory submissions.
- Excellent written and spoken communication skills.
- Prior experience working with external partners in a cross-cultural environment. Understanding of cross-cultural sensitivities and influencing skills.
- Experience in the field of cytometry or cell analysis.
- Certified Scrum Master and/or Product Owner.
- Knowledge of fluidics, optics, and/or assay reagents is also helpful.
- Previous Design Control/Design for Six Sigmaexperience.
- INCOSE CSEP Certification.
- ASQ CQE Certification.
- 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 & engineeringinvestigation techniques (DMAIC/six sigma black belt an asset).
- Experience in developing and executing system integration as V&V engineer or performance characterization test procedures through virtual simulation and real test scenarios.
Job ID R-24982