Work Flexibility: Hybrid
The Senior Principal Engineer, Product Transfer & Validation Quality Engineering provides senior technical leadership for quality engineering activities associated with product transfers, manufacturing process introductions, process validation and the implementation of new technologies across the manufacturing network.
The role leads the development and execution of robust, compliant and scalable quality strategies to ensure products and processes are successfully transferred into manufacturing while meeting applicable quality system and regulatory requirements.
Operating with a high degree of independence, the Senior Principal Engineer provides technical direction on complex product and process challenges, particularly where technical, regulatory, validation, quality, capacity and business constraints must be balanced. The role serves as a technical authority and mentor within Product Transfer Quality Engineering and partners closely with Product Trasnfer, Operations, R&D, Regulatory, Quality and other cross-functional stakeholders.
Key Areas of Responsibility
Product Transfer & Technical Leadership
- Provide senior Quality Engineering leadership for product transfers, manufacturing process introductions and technology transfers across manufacturing sites.
- Develop and drive the Quality Engineering strategy for complex transfer programmes from initial planning through process qualification, validation and production readiness.
- Ensure appropriate quality requirements and deliverables are incorporated into project plans, design-transfer activities and key project milestones.
- Provide independent technical review, challenge and guidance on significant product-transfer and validation decisions.
- Develop solutions to complex technical and compliance challenges, particularly where conflicting technical, regulatory or business constraints exist.
- Identify and escalate significant product, process or quality-system risks and drive appropriate cross-functional resolution.
Validation & Process Qualification
- Provide technical leadership for the development and execution of risk-based validation strategies for manufacturing processes, equipment, inspection methods and associated systems.
- Lead and support validation planning, protocol development, execution, technical review and approval.
- Ensure validation activities demonstrate that manufacturing processes and equipment are capable of consistently meeting defined product and process requirements.
- Provide technical oversight of complex validation challenges and ensure appropriate scientific and statistical rationale supports validation decisions.
- Drive consistency and best practice in validation approaches across Product Transfer Quality Engineering.
Risk Management & Process Control
- Lead the development and application of process risk management, including pFMEA, to identify and mitigate manufacturing and product risks.
- Ensure identified risks are appropriately translated into process controls, inspection strategies and validation requirements.
- Drive robust inspection and control strategies incorporating Critical Quality Attributes (CQAs), Critical-to-Quality characteristics (CTQs) and Measurement System Analysis (MSA).
- Ensure control strategies support effective process characterisation, capability assessment, ongoing process control and early identification of process deterioration.
- Promote risk-based decision-making throughout the product-transfer lifecycle.
Quality Systems & Regulatory Compliance
- Ensure Product Transfer and validation activities comply with applicable Quality Management System and regulatory requirements.
- Ensure robust and compliant product-transfer documentation, providing clear evidence that manufacturing requirements have been appropriately established, verified and transferred.
- Provide technical Quality Engineering input into procedures, standards and processes supporting product transfer and validation.
- Ensure systems and processes are established to protect product quality, patient safety and regulatory compliance.
- Support the identification and resolution of systemic quality or compliance issues arising during transfer and validation.
Cross-Functional & Multi-Site Collaboration
- Act as a senior technical partner to Product Transfer, Validation, Operations, R&D, Regulatory and Quality teams.
- Provide technical Quality Engineering direction across sending and receiving sites during product transfers.
- Facilitate effective technical decision-making between functions and manufacturing locations.
- Promote standardisation, knowledge sharing and application of best practices across the manufacturing network.
Technical Leadership, Coaching & Capability Development
- Serve as a technical authority and subject-matter expert for Product Transfer and Validation Quality Engineering.
- Mentor and coach Quality Engineers and junior engineering personnel in validation, process risk management, problem solving and Quality Engineering principles.
- Develop the technical capability of the wider Quality Engineering organisation through coaching, technical reviews and knowledge sharing.
- Influence technical decisions across functions and sites without reliance on direct organisational authority.
- Promote a culture of technical excellence, accountability, continuous improvement and compliance.
Key Competencies
- Advanced Product Transfer and Validation Quality Engineering expertise.
- Strong understanding of manufacturing process development, qualification and validation.
- Expertise in pFMEA, process risk management, control plans, CTQs, CQAs and validations.
- Strong knowledge of statistical methods, process capability and process characterisation.
- Demonstrated ability to solve complex technical and compliance problems.
- Ability to provide technical leadership across multiple projects, functions and manufacturing sites.
- Strong technical judgement and ability to make risk-based decisions with incomplete or competing information.
- Excellent communication, influencing and stakeholder-management capability.
- Strong coaching and mentoring capability.
- Ability to operate independently and provide direction on technically complex programmes.
Qualifications, Knowledge & Experience
- Bachelor's degree in Engineering, Quality, Science or a related technical discipline; an advanced technical degree is advantageous.
- Significant experience in Quality Engineering, engineering, validation, product transfer or process development within a regulated environment.
- Demonstrated experience leading technically complex product or manufacturing process transfers.
- Strong practical experience in process validation, risk management and statistical Quality Engineering techniques.
- Experience developing and reviewing validation strategies and technical documentation.
- Experience working across multiple functions and manufacturing locations.
- Demonstrated ability to mentor engineers and provide technical leadership at organisational level.
Expected travel: 30%
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Ireland Pay Ranges:
- Ireland: €84,000 - €139,000 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.
If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.
Travel Percentage: 30%