Senior Engineer, Advanced Quality

About the role

Stryker is looking for a Senior (Advanced) Quality Engineer in Carrigtwohill, Ireland. This is a permanent hybrid role with full Stryker benefits, working on new product development projects. The engineer influences Engineering and Advanced Operations to define design requirements and develop manufacturing processes, driving reliability, human factors, risk management and design validation while ensuring compliance with Stryker's quality system, FDA QSR, ISO 13485 and other medical device regulations.

Key responsibilities

• Develop quality assurance documentation for new product development and regulatory submissions, and guide new product teams through internal quality system requirements.
• Influence cross-functional teams to build quality into product and process design, and support quality system maintenance by fixing deficiencies in procedures and practices.
• Lead risk management for new products, including risk analysis, mitigation strategies and residual risk evaluation before launch, presenting the risk/benefit justification to executive leadership.
• Take part in design reviews, define design verification and validation test requirements, and support design engineering and Advanced Operations in defining manufacturing processes and process controls.
• Use quality engineering tools, statistical methods and design development methods to build quality into new products.
• Develop, review and approve inspection plans, routers and product drawings, and evaluate project deliverables for technical competence and compliance.
• Analyse critical quality attributes through risk analysis, support design transfers to internal and external manufacturers, and evaluate predicate products.
• Collect initial market feedback, lead formative and summative studies with customers, and lead design validation so products meet customer user needs.
• May lead NC and CAPA, requiring problem-solving and root cause analysis expertise.

Required profile

• Bachelor's degree in a science, engineering or related discipline (Level 8).
• Minimum 2+ years of experience in a Technical Engineering or Quality Engineering position within R&D or manufacturing.
• Preferred: experience with the medical device product development lifecycle, including risk management and design/process verification and validation.

What we offer

• Permanent hybrid role with full Stryker benefits.
• Pay range in Ireland of EUR 47,000 - 77,000 per year, plus possible incentive compensation.
• Approximately 10% travel.