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Lead Design Quality Engineer

Req ID: J2343704-IL

  • Location
    St. Petersburg/Tampa, Florida, United States of America
  • Category Quality Group
  • Posted Thursday, November 17, 2022
  • Type Full time
  • Job Type Permanent Employee

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.

Job Description

Position Summary

This individual will be responsible for supporting product development and ensuring development quality for complex electro‐mechanical medical devices. He or she will actively participate and oversee, as a development team member, the planning, development, review, verification, and risk management activities associated with medical device development projects. This individual's responsibilities will include supporting all product design activities and ensuring proper execution of the development process as well as the resulting documentation and records. This position provides guidance to development teams on applicable regulatory and statutory process and product requirements.

Additional responsibilities may include assisting in the development of processes and participating in process improvement projects.

Responsibilities

  • Participate in development of project design and development plans
  • Participate in development of Customer and Design Input Requirements.
  • Participate in project status reviews and product design reviews.
  • Ensure development projects meet defined development process requirements of FDA 21CFR820.30 and EN/ISO13485:2016.
  • Ensure software development is compliant with IEC 63204:2015 standard.
  • Ensure compliance with IEC60601/EN60601 safety standard series.
  • Guidance on statistical methods for sampling plans, data analysis and design of experiments.
  • Support design verification testing including; providing guidance in developing and validating test methods, reviewing and approving verification records.
  • Facilitate and oversee the development of risk management activities for projects.
  • Ensure timely completion of all Quality Assurance deliverables to support the design and development projects.
  • Manage developmental design change process for each project s drawings and specifications.
  • Manage document control of each project team’s developmental documentation
  • Ensure the quality of all design and development documents and records, so that they readily support regulatory submissions.
  • Organization and compilation of project’s/product’s design history record set
  • Support internal and external audits as required.
  • Other related duties as may be assigned.

Education

  • BS/BA Degree in Electrical or Mechanical Engineering or other equivalent combination of education and relevant work experience.

Qualifications

  • Formal Training in FDA 21 CFR 280 Quality System Regulation
  • Formal Training in ISO 13485:2016
  • Lead Auditor Certification – ISO13485:2016
  • 7 years of medical device design assurance experience or 3 Years of medical device design assurance experience with 4 years of medical device/quality experience.
  • Thorough working understanding of 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304 requirements.
  • Advanced analytical and problem‐solving including application of statistical methods.
  • Experience with IEC 60601 series of safety standards.
  • Tenacious attention to detail
  • An approachable individual who provides a high level of teamwork & cross‐functional collaboration.
  • Outstanding communication and interpersonal skills within all levels of the organization

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.

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 Jabil.com/Careers 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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