My client an exciting new start up here in Galway are looing to hire a Senior Design Assurance Engineer.
As the senior design assurance engineer you will provide quality support in the design and development of these new cutting edge medical device products. You will work with a cross-functional team and external vendors to ensure safety, quality, and compliance of products. You will do this by leading product development of cutting edge technology and you will be responsible for activities such as, but not limited to, risk management; generation of design history file documents; design verification and validation; product testing and methods; and ensuring compliance to relevant standards.
- Work with product development to establish design specifications and product requirements and maintain associated documentation.
- Generation and review of quality and technical documentation/change requests to support design activities, ensuring adherence to internal and regulatory requirements
- Lead risk management process and preparation of risk management files (e.g. Hazard Analysis, FMEAs).
- Generate design verification and validation plans, protocols and reports, including advising on sample sizing. Bodies of testing may include sterilization, biocompatibility, and stability and transportation testing.
- Devise methods and procedures for inspection, testing, and evaluation of product, and associated validations.
- Liaise with external vendors and in-house resources for product testing.
- Bachelor’s degree in engineering, science, or related discipline.
- 4+ years of experience in quality/design assurance or new product development in the medical device or pharmaceutical industry.
- Knowledge of product development process and design control requirements
- Knowledge and practical experience with the use of quality tools/methodologies (e.g. statistical techniques, validations, eQMS, root cause analysis)
- Strong communication skills (verbal & written)
- Ability to effectively work and collaborate in a mixed onsite plus remote environment.
- Experience with software and electronic related devices is an advantage.
For more information on this role and a confidential discussion please contact Amy Newell on 091 706 718 or email Amy.firstname.lastname@example.org