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.
- 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.
- BS/BA Degree in an Engineering or other scientific discipline or combination of education and relevant work experience.
- 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
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