A large global manufacturing solutions provider based just outside of St. Petersburg, FL is looking for an Design Engineer . Qualified candidates must have the following skills:
- 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.
- PCB Design
- Schematic Capture
location: SAINT PETERSBURG, Florida
job type: Contract
salary: $48.00 - 56.25 per hour
work hours: 8am to 4pm
- 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.
- Experience level: Experienced
- Minimum 6 years of experience
- Education: Bachelors (required)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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