Principal Systems Engineer

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Principal Systems Engineer – Medical Instrumentation R&D

Position Summary:

Using Systems Engineering procedures standard to research and development, carries out assignments (at this mid sized, successful and growing medical instrument company) with research, design, or development, and the manufacturing of specific parts and components of medical diagnostic systems. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Under the general direction of a department manager, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific section or department. Demonstration of strong development, leadership, and management skills will allow transition into a lead technical or functional role.

Key Accountabilities:

  • Directs the Systems Engineering work of engineers and technicians assigned to him/her on a given project.
  • Provides input to yearly employee reviews.
  • 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.
  • Act as a technical lead for a specific project.
  • Plans, performs and coordinates technical work, experiments and integration studies with minimal supervision.
  • Effectively performs trade off analysis.
  • Leads and/or participates in FMECA, FTA, traceability activities, requirements elicitation/review, integration testing, reliability activities, triage and verification activities 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, architecture, and configuration management deliverables.
  • Provides technical support for CAPA investigations.

Skills & Capabilities:

  • Electro-mechanical product design experience throughout the design life cycle
  • Application of fluid dynamics, heat transfer, control systems, electonics, & programming in engineering design & test
  • Assembling and integrating data acquisition systems for testing
  • Error budgeting, modeling and simulation
  • Adapts to change quickly and is able to multi-task, managing several activities or projects simultaneously.
  • Demonstrates proficiency in performing root cause analysis and initiating and leading troubleshooting activities.
  • Demonstrates strong development, management and leadership skills with the ability to think independently.
  • Demonstrates technical confidence to interact with engineers of other disciplines, supports technical discussions, and demonstrates the ability to make technical decisions
  • Ability to produce quality written work, such as, technical reports, protocol and plans.
  • Ability to skillfully present work and communicate ideas effectively to a multi-disciplinary teams.
  • Ability to understand complex system interactions and the effect on analytical performance

Min Knowledge & Experience required for the position:

  • B.A./B.S. with a minimum 8 years of experience or M.S. with 6 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 highly desired: Six Sigma, DOE, Failure Analysis, FMEA, Minitab, Lab View, MathCAD, MatLAB, Word, Power Point, Excel, IBM DOORS.
  • Knowledge of Systems Engineering theories and practices with the ability to effectively incorporate these practices.

International Mobility: Required: yes Some domestic and international travel may be required

CONTACT John Compton jcompton@agilesearchinc.com

Mar, 26, 2019

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