• Directs the Systems Engineering work of engineers and technicians.
• Provides technical support for Operations and Service department’s requests for Systems Engineering Support.
• Provides input to schedule for Systems Engineering activities related to assigned projects.
• Provides input to metrics for each project within the program to monitor development time to aid in the creation of predictable schedules.
• Independently prioritizes tasks in alignment with corporate goals and objectives.
• Designs and develops new test methods and processes for complex parts, components and systems functions.
• Recommends new tools to optimize processes, procedures and test methods.
• Effectively performs trade off analysis.
• Leads and/or participates in FMECA, FTA, traceability activities, and requirements elicitation/review across a given project.
• Leads and/or supports root cause investigations in support of on-market complaints.
• Able to identify product defects and outliers in results.
• Participates in and/or challenges designs, tolerance studies, change requests, procedures, test methods, protocols and reports and assists in resolution of conflicting design requirements.
• Authors and/or reviews project sub-plans, requirements, risk management, protocols, reports, and architecture deliverables.
• Provides technical support for CAPA investigations.
• Adheres to c::11 Systems Engineering and design control processes.
• Provides input to yearly employee reviews.
• B.A./B.S. with a minimum 6 years of experience or M.S. with 4 years of experience or equivalent combination of education and experience in Engineering, Science or related field, (Biology, Chemistry, Physics, Biotechnology, Biomedical, Electrical, Mechanical, Chemical Engineering).
• In-vitro medical device experience highly desired.
• Demonstrates strong knowledge of ISO 14971, ISO and FDA design control requirements
• Experience with the following tools/methods higher desired: Six Sigma, DOE, Failure Analysis, FMEA, Minitab, Lab View, MathCAD, MathLAB, Word, Power Point, Excel, IBM DOORS.
• Knowledge of Systems Engineering theories and practices with the ability to effectively incorporate these practices.
• Some domestic and international travel may be required
Inquiries and resumes to: Kathy Provost at email@example.com OR 978/952-6425
For more information, please visit http://www.agilesearchinc.com/