Senior Engineer, Advanced Quality

Stryker Corporation; Carrigtwohill; Hybrid; EUR 47,000 - 77,000; Full time

Job summary

Stryker Ireland is seeking a Senior (Advanced) Quality Engineer to influence design verification, risk management, and manufacturing processes for new product development. The role ensures compliance with FDA QSR, ISO 13485 and the Stryker quality system while driving reliability, human factors engineering, and measurement of product quality across development teams.

Hybrid or onsite work with full benefits.

Qualifications

• Bachelor in science or engineering (Level 8).
• 2+ years in technical or quality engineering in R&D or manufacturing.
• Experience with medical device lifecycle, risk management, and V&V.

Responsibilities

• Define design requirements and develop manufacturing processes for new product development.
• Drive reliability engineering, risk management and design validation.
• Develop QA documentation to support new product development and regulatory submissions.
• Guide product development teams through internal quality system requirements.
• Lead risk analyses and mitigation strategies for new products.
• Engage in design reviews and verify/validate testing to ensure acceptance criteria.

Skills

Quality engineering

Risk management

Design validation

Statistical methods

Education

Bachelors in science/engineering (Level 8)

Tools

FDA QSR compliance

ISO 13485

Job description

Work Flexibility

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:

• As a Senior (Advanced) Quality Engineer, you will influence Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects.
• You will have the responsibility to drive reliability engineering, human factors engineering, risk management, and design validation, while ensuring compliance to Stryker quality system, FDA Quality System Regulations, ISO 13485 and other medical device regulations.
• 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

Travel Percentage: 10%

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.

We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility (continued)

• Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
• Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
• Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.