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Sustaining Design Quality Engineer

Job Post Index 212F3E-Sy##
Location Westford, MA
Description: Description
  • Sustain design quality engineering to support the FFR and OCT hardware portion of our business
  • Applies engineering and scientific principles to the evaluation and solution of technical problems.
  • Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work.
  • Performs engineering studies.
  • Remains abreast of and consults on technical advancements.
  • Identifies and routinely uses the most effective and cost-efficient practices to execute processes
  • Continually evaluates their effectiveness and appropriateness.
  • Support all sustaining activities around catheter and capital hardware console manufacturing including end of life, supplier change
    requests, Global compliance standards, IFU/Label changes, support of regulatory submissions, corporate programs, literature review, and all supporting quality system elements
  • Support the following manufacturing elements:
  • Production support process validation, and design changes and design verification and validation
  • Interface with vendors for components
  • Support CAPA investigations
  • Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
  • Protocol and report writing
  • Work with cross functional teams as required
  • Develop and implement process improvements
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating
    procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels employees, customers, contractors, and vendors.
  • Works with standard office equipment such as telephone, cellular phone, fax/copier, and a personal computer with standard office software.
  • May also visit research labs, testing labs, production and other areas as well as vendor facilities as necessary.
Skills: Qualifications
  • Bachelor of Science in electrical/electronic engineering or related engineering field.
  • A minimum of six (6) + years of relevant work experience in performing the layout construction, and evaluation of a variety of Printed Circuit Boards, fixtures and tools.
  • Experience with product development a plus.
  • Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes,
    policies and tasks.
  • Demonstrated personal computer skills, including spreadsheet, word processing, database management, and specialized applications.
  • Training and experience in manufacturing processes and methods desired, especially in the manufacturing of medical devices.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Knowledge of analog electronics
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Advanced credential or professional certification in a relevant discipline/concentration desired.
  • Six-Sigma knowledge and experience desired.
  • Experience with fiber optics is beneficial
  • Working knowledge of laser equipment is beneficial
  • Capital equipment experience is preferred

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