- Reference: GJ42142
- Job Type: Permanent
- Location: Galway, Limerick, Mayo
- Category: Engineering, Technical & Manufacturing
As Senior Design Assurance Engineer you provide input to our clients contract development teams in the design of highly complex medical devices. They ensure that compliance to customer and regulatory requirements is demonstrated and help to ensure successful transfer of the design to manufacturing. They are responsible for accurate, independent evaluation of Design History File documentation and overall Quality System compliance.
You will be working with a small team of 3-4 people and there are lots of progression opportunities in this role.
Key Job Responsibilities:
- You wil have responsibility of all aspects of design control. Involved in inputs -verification – validation – working with physicians.
- Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria.
- Works closely with product development engineering and the client team to establish the system design specifications and product requirements.
- Works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles.
- Performs and documents all engineering studies and reports to satisfy the master verification plan.
- Plans, coordinates and executes design verification testing to directly support the master verification plan.
- Participates with the engineering team to establish and review the design FMEA.
- Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment.
- Possesses a comprehensive understanding of ISO10555 principles, design FMEA practices, and any industry standards to ensure products satisfy all ISO 13485 requirements.
- Support various QA/RA activities including quality management, system reviews, audits, etc.
- Support risk management activities
- Evaluation of new products, assuring the safety and efficacy of the devices
- Design verification and shelf life protocols / reports review.
- Root cause investigations; drive problem solving efforts for quality issues
- Clear present information to Regulatory Affairs to minimize Regulatory Agency questions
- Support customer complaint analysis and post market surveillance activities
- Generate and approve change requests
- Design Control expereince
- Risk management / ISO14971 experience
- Familiar with product specific requirements – ISO555 PART 1 (standard for intravascular catheters).
- Proven experience dealing with a device from concept through to verification, validation, risk assessment through to regulatory submittal.
- As Senior Design Assurance Engineer you need to take a project and run with it & have proven experience with this.
- Candidates must have 3-5 years of relevant experience with a Bachelors degree or higher in Engineering, or a related discipline.
- Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations.
- Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers.
- Must be able to travel occasionally to meet with customers / project teams
For a confidential discussion and a more detailed job spec (more information on the role), please contact Christopher O Toole on 091-706713 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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