Agile Programming Methodologies, Analysis Skills, Association for the Advancement of Medical Instrumentation (AAMI), Biomedicine, Biotech and Pharmaceutical, Cross-Functional, Data Analysis, Electricity, Electromechanics, Failure Mode and Effects Analysis (FMEA), ISO (International Organization for Standardization), Identify Issues, International Electro-Technical Commission (IEC), Performance Analysis, Problem Solving Skills, Process Improvement, Product Development, Risk Management, Root Cause Analysis, Systems Engineering, Team Lead/Manager, Test Strategy, United States Department of Energy (DOE), V&V Testing, Validation Testing
Senior Systems Engineer ROCGJP00040246
- Hourly pay: $45/hr
- Worksite: Leading biotechnology company (Tucson, AZ 85755 - Onsite)
- W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
- 40 hours/week, 12 Month Assignment (With possibility of extension)
A leading biotechnology company is seeking a Senior Systems Engineer tooperate within the Product Development organization, specifically supporting the On Market Support (OMS) area, applying intensive, diversified knowledge of design principles to complex assignments.
Senior Systems Engineer Responsibilities:
- Leads efforts to define new components, products, processes, or improvements through data analysis and result evaluation.
- Generating design concepts, participating in reviews, and executing experiments (including DOE) to assess performance against specifications.
- Planning and executing assigned projects, identifying technical challenges, and developing potentially patentable components or processes.
- Troubleshooting issues to determine root causes, analyzing data, and implementing process or document improvements.
- Leads cross-functional technical teams, sharing expertise and presenting project results to internal or external groups.
Senior Systems Engineer Qualifications:
- 8 years of related experience and a Bachelor’s degree in Engineering (Systems, Biomedical, Electrical, Mechanical, Chemical).
- 4 years of related experience and a Master’s degree in Engineering is a plus.
- Experience with electro-mechanical devices.
- Expertise in developing, preparing, and executing comprehensive verification and validation (V&V) test strategies.
- Strong knowledge of requirements engineering, risk management principles, and elicitation techniques, specifically using methodologies like FMEA.
- Expertise in defining problems and conducting thorough causal analysis using structured problem-solving tools.
- Proven ability to identify and document actionable root causes that lead to solutions.
- Familiarity or experience with IEC 61010, AAMI, ISO 13485, or SAFe Agile methodology.
- INCOSE certification is a plus.
- Strong knowledge of engineering principles and concepts, with a proven ability to apply technical proficiency, creativity, and independent thought.