Senior Design Assurance Engineer
Senior Design Assurance Engineer
My leadng MNC medical device client are hiring for a Senior Design Assurance Engineer to join thier Galway site on a permanent basis.
Job Purpose: Fulfil the quality assurance responsibilities of the company’s product development and related sustaining engineering activities, including:
- Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality
- Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry
- Promoting and effecting compliance to the company’s quality, business and health & safety systems and market/legal regulations.
- Analysing, reducing and managing risks associated with the design, use and manufacture of medical devices.
- Providing expertise in product development systems to project teams
- Supervising, leading and coaching members of the design assurance department
- Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.
- Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements.
- Monitor the release and updates of quality policies to ensure compliance with Product Development needs and communication of this information to the Product Development Group.
- Continually seeks to drive improvements in product and process quality.
- Implement, maintain and update procedures that ensure that R&D documentation constantly meets Product Development Process and Design Control requirements.
- Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
- Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
- Identifies and resolves complex exceptions to work assignments.
- Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
- Fully conversant with verification/validation techniques, risk management, statistical techniques and associated regulatory requirements
- Build Quality into all aspects of work by maintaining compliance to all quality requirements.
- Keeps up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group.
- Is an active member of the project team, formulating strategy and leading execution on quality deliverables as outlined in Product Development Process (PDP), Recertification, Risk Management and Design Control SOPs.
- Co-ordination of team activities in line with departmental objectives and project goals.
- Supervision and development of staff reporting to them in line with departmental and project goals.
- Uses opportunities in project assignments to develop other team members.
- Coaches others in analysis and decision making. A source of technical guidance to Quality Engineer II, Quality Engineer I, Graduate Quality Engineer, Technician and Inspection staff.
- Is perceived as a proponent of change within the project/department and willing to challenge the status quo to create best in class.
- Is a good team member, committed to the projects success and fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
- Provide guidance on design control requirements to PDP/TDP teams and sustaining engineering activities in line with policies and procedures.
Qualifications and Experience:
- NFQ Level 8 (240 credits) in a relevant STEM discipline with a minimum of 5 years’ experience in a similar role.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well as part of a team & on own with minimum supervision.
- Knowledge & understanding of EN ISO 5840-3 is essential.
- Material knowledge of nitinol and any experience with testing of nitinol is desirable.
- Material knowledge of animal origin (bovine or porcine) is desirable.
- Basic knowledge/understanding of valve testing/kinematics.
- Basic knowledge of Finite Element Analysis.
For further information on this Senior Design Assurance role in Galway please contact Amanda Reynolds on 0860468858/ firstname.lastname@example.org
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