Design Quality Engineer (Medical Device Product Development)
Posted on: 10 Oct 2022
Tampa, FL | St Petersburg, FL
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 an Engineering or other scientific discipline or combination of education and relevant work experience.
Qualifications
6 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 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 and cross-functional collaboration.
Outstanding communication and interpersonal skills within all levels of the organization
Jabil Inc.
St Petersburg, FL
Jabil Inc. provides electronic manufacturing services and solutions worldwide. The company operates through two segments, Electronics Manufacturing Services and Diversified Manufacturing Services. It offers electronics design, production, and product management services. The company provides electronic circuit design services, such as application-specific integrated circuit design, firmware development and rapid prototyping services; and designs plastic and metal enclosures that include the electro-mechanics, such as the printed circuit board assemblies (PCBA).
It also specializes in three-dimensional mechanical design comprising the analysis of electronic, electro-mechanical, and optical assemblies, as well as offers various industrial design, advance mechanism development, and tooling management services. In addition, the company provides computer-assisted design services consisting of PCBA design, and PCBA design validation and verification services; and other consulting services, including the generation of a bill of materials, approved vendor list, and assembly equipment configuration for various PCBA designs. Further, it offers product and process validation services, such as product system, product safety, regulatory compliance, and reliability tests, as well as manufacturing test solution development services. Additionally, the company offers systems assembly, test, direct-order fulfillment, and configure-to-order services.
It serves automotive and transportation, capital equipment, computing and storage, defense and aerospace, digital home, industrial and energy, networking and telecommunications, point of sale, printing, consumer wearables, healthcare, mobility, and packaging industries. The company was formerly known as Jabil Circuit, Inc. and changed its name to Jabil Inc. in June 2017. Jabil Inc. was founded in 1966 and is headquartered in Saint Petersburg, Florida.
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IndustryManufacturing
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No. of Employees199, 000
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Website
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