This position will be in the Systems Engineering Team. This is a position on the Technical Leadership Career Track. This is a demanding/challenging, high-visibility position which requires frequent interactions with Executive Management as well as cross-functional influencing skills.
- 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 be proficient in the application of Systems Engineering techniques such as Requirements synthesis/management/traceability, Systems Modeling, 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 and mitigation/implementation of program 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 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.
- 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 medical device/IVD projects.
- Experience and Proficiency with Product Architecting (Functional/Physical) and Platform (integral/modular) Creation Tools. Candidates without this experience will not be considered.
- 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.
- Experience in the field of 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.
- Previous Design Control/Design for Six Sigmaexperience.
- INCOSE CSEP 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-22707