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Design Quality Engineer III (Medical Device)

Req ID: J2303252

  • Location
    Clinton, Massachusetts, United States of America
  • Category Quality Group
  • Posted Friday, April 8, 2022
  • Time Type Full time
  • Job Type Permanent Employee

Job Description

Radius & Jabil Healthcare Engineering & Technologies (JHET) in Clinton, MA is looking for a Design Quality Engineer III to participate in commercial, consumer, and medical device design projects. The optimal candidate is highly motivated in team environments and thrives within a culture of innovation.

The position of Quality Engineer III is responsible for supporting the product development process and quality management system though development, maintenance and continuous improvement of test, design control, risk management and material documentation. This individual will report directly the Quality Manager. The individual in this role will bring to bear world class quality knowledge, product development experience, planning and communication skills to deliver winning solutions for Radius clients.

PRIMARY DUTIES AND RESPONSIBILITIES

  • Identify, review and interpret industry, regulatory, environmental, mechanical and electrical standards and requirements

  • Participate in the development and review of test strategies, product requirements and design inputs based on project phase

  • Develop, manage and execute test project documentation including, but not limited to test plans, methods, data, data analysis, data audit, data presentations and reports for concept, prototype (engineering qualification) and pilot (design verification) testing.

  • Select / design, procure and troubleshoot test equipment and fixtures

  • Develop, document and validate test methods

  • Identify, qualify and manage external test suppliers

  • Lead root cause analysis of test failures

  • Participate in design inputs and design outputs reviews

  • Collect and manage content of project design history files (DHF)

  • Participate in quality management system processes and documentation including, but not limited to training records, calibration records, supplier records, engineering change orders (ECO), non-conforming material review (NCMR), corrective and preventative actions (CAPA) and document retention schedules 

  • Develop site-level quality management system procedures and templates

  • Lead internal audits and support notified body / ISO registrar and customer audits of the quality management system

  • Provide guidance to project teams and customers on compliance with the quality management system

  • Develop, manage and execute processes and documentation for receipt, acceptance, assembly and release of prototype/pilot materials for assembly by Radius

  • Complete and document prototype/pilot assembly, release testing and distribution to supplier and customers

  • Participate in project planning through proposal development and review


MINIMUM EDUCATIONAL REQUIREMENTS

  • Bachelors degree in engineering, science or technology related field

MINIMUM PRIOR WORK EXPERIENCE TYPICALLY REQUIRED

  • Two years of hands-on product development experience

  • Experience with medical industry regulation, risk management and design controls (ISO 13485, ISO 14971, FDA, CFR, etc.)

ESSENTIAL SKILLS REQUIRED:

  • Motivated, takes initiative

  • Good interpersonal skills

  • Excellent written and verbal communication skills

  • Strong mechanical aptitude

  • Learns and understands information quickly

  • Attention to detail

  • Commitment to excellence and high ethical standards

  • Strong organizational, problem-solving, and analytical skills

  • Ability to manage priorities and support multiple projects effectively

  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm

  • A knowledge of statistical sampling techniques and analysis for determination of sample size and summary of qualitative and quantitative data in research & development, product testing and manufacturing

  • Passionate about working in a team with other disciplines (Business Development, Research, Human Factors, Design, Engineering, Implementation)

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access https://careers.jabil.com/ site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address.

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