Senior Engineer, Advanced Quality

Stryker; Cork; Híbrido; EUR 47.000 - 77.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Full benefits

Hybrid/onsite option

Descripción de la vacante

Stryker in Ireland is seeking a Quality Engineer to drive design controls, risk management and regulatory readiness across new product development. Hybrid or onsite work with full benefits supports a hands-on engineer focused on robust, compliant medical devices.

You will develop QA documentation, guide teams through internal quality systems, and lead cross‑functional risk analyses to ensure launch readiness and patient safety.

Formación

• Bachelor's degree in science, engineering, or related discipline.
• 2+ years in technical or quality engineering.
• Experience in medical device development lifecycle preferred.

Responsabilidades

• Develop QA documentation to support development and regulatory submissions.
• Guide teams through internal QA systems to launch products.
• Lead risk management and mitigation strategies.
• Define design verification and validation test requirements.
• Support design transfers to manufacturing.
• Lead design reviews and conduct product risk analyses.

Conocimientos

Cross-functional collaboration

Quality mindset

Risk assessment

Problem solving

Educación

Bachelor's degree in science/engineering

Descripción del empleo

Work Flexibility: Hybrid or Onsite

This is a permanent hybrid role with full Stryker benefits.

Who we want

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What you will do:

• Develop quality assurance documentation to support new product development process and regulatory submissions.
• You will guide new product development teams through internal quality system requirements to launch new products.
• You will influence cross-functional project teams to build quality into product and/or process design and development activities.
• Support quality system maintenance by identifying and correcting deficiencies in procedures and practices.
• You will lead risk management for new development products , including risk analysis and development of sound mitigation strategies.
• Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
• Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
• Support design engineering and advanced operations team in problem solving.
• Support Advanced Operations in the definition and development of manufacturing processes and process controls for new products.
• You will use quality engineering tools, statistical methods, design development methods, process development and control methods, and design verification and validation planning to build quality into new products during development.
• Develop, review, and approve inspection plans, routers, and product drawings for new products.
• You will evaluate project tangibles for technical competence and compliance to ensure we are delivering robust products.
• Analyze and define critical quality attributes for product and process through risk analysis techniques.
• Support product design transfers to internal and/or external manufacturing facilities.
• Evaluate predicate products for relevant quality issues that may impact new product development projects.
• Participate in collection of initial market feedback on new products and address early concerns.
• You will lead formative and summative studies with our customers and other human factors engineering activities to develop intuitive and safe new products.
• You will lead design validation efforts to ensure new products meet all customer user needs.
• You may lead NC & CAPA, which require expertise in problem solving and root cause analysis.

What you need:

• Bachelors in a science, engineering or related discipline (Level 8) .
• A minimum of 2 + years of experience in a Technical Engineering or Quality Engineering position within an R&D or manufacturing environment .
• Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.

Ireland Pay Ranges: Ireland : €47,000 - €77,000 EUR Annual

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.

Travel Percentage: 10%