18 days old

Systems Engineer Medical Device

Battelle Memorial Institute
Columbus, Ohio 43201-2696
  • Job Code
    69044
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

Battelle’s founding mission “to translate scientific discovery and technology advances into societal benefit” is as relevant today as when we opened our doors over 90 years ago. Our science and technology enhance society's well-being and create critical innovations that drive scientific advances for the future. We conduct groundbreaking research and development, design and manufacture leading-edge products, and deliver critical services for commercial and government customers. Our work meets the needs of the nation when it matters most, and Battelle is committed to driving innovation today and for generations to come.

JOB SUMMARY

We are currently seeking a Medical Device Systems Engineer III. This position located in Columbus, Ohio.

The Medical Device Solutions group is hired by external companies from startups to Fortune 100 to assist them with their product development needs. Clients choose to work with us because of a proven track record for developing innovative and marketable solutions to challenging technical problems. The Systems Engineer will be an integral part of the multi-disciplinary teams that we form around each project. A large focus for the group is on medical device development. This has included projects for mass produced drug delivery devices, immunodiagnostic systems, surgery tools, large scale imaging systems, and more. Regardless of whether the device is in the user’s hands or part of a larger system of care, they all are driven by the same ambition - to positively affect the user’s health outcome.

MAJOR RESPONSIBILITIES

Provides technical leadership to small or medium sized project teams to ensure interdisciplinary integration is met. This position is responsible for considering the complete problem across the entire lifecycle of the product. These responsibilities include:

 

  • Defining customer needs and required product functionality.
  • Documenting product requirements and project constraints.
  • Leading, guiding, and/or performing the technical product development for the system or subsystem being developed—providing and supporting the big picture systems view. This includes tracking key technical metrics to measure margins and risk.
  • Overseeing and leading verification and validation planning, execution, and reporting efforts.
  • Navigating or supporting the team and the product through regulatory compliance activities.
  • Ensuring efficient and complete transition from design into production.
  • Prepares and presents documentation to clients and stakeholders.


This position is also tasked with supporting our business development efforts including writing proposals, planning technical aspects of projects, developing our capabilities, interfacing with current and prospective clients, and participating in conferences.
 

Requirements

  • Bachelors Degree in engineering discipline relevant to product development.
  • 6+ years of systems engineering experience, with at least 5 years in new product development.  (Or Master's degree and 4 years)
  • Demonstrated track record of successful product development on dynamic projects.
  • Proven abilities in leading cross functional technical teams, managing risk, and adapting to change.
  • Self-motivated, organized, and a problem solver who demonstrates knowledge of fundamentals but also the big picture.
  • Excellent communication skills to support interaction with cross-functional team members, internal management, and clients.
  • Requires US persons as defined by US export control laws.

THE FOLLOWING IS DESIRED

  • An advanced degree in Engineering, Science, or Business.
  • Experience working under an ISO 13485 registered quality system.
  • Experience registering products through FDA regulations (such as 510(k)).
  • Experience with ISO 14971 and/or experience in conducting safety risk management activities (e.g. Hazard Analyses, FTA, and various FMEAs).

BENEFITS

Battelle’s competitive benefits program includes comprehensive medical and dental care, matching 401K, paid time off, flexible spending accounts, disability coverage, and other benefits that help provide financial protection for you and your family.

Battelle provides employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex (including pregnancy), national origin, sexual orientation, gender identity or expression, marital status, age, genetic information, disability, veteran-status, or any other characteristic protected under applicable Federal, state, or local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle.

 

For more information about our other openings, please visit www.battelle.org/careers

Categories

Posted: 2021-02-09 Expires: 2021-03-11

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Systems Engineer Medical Device

Battelle Memorial Institute
Columbus, Ohio 43201-2696

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