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Senior Staff Engineer, Advanced Operations - Job Opportunity at Stryker

Carrigtwohill, Ireland
Full-time
Senior
Posted: June 2, 2025
Hybrid
EUR 85,000 - 105,000 annually based on senior engineering role in Ireland's medical device sector, considering Stryker's market position as a Fortune 500 company and the specialized nature of FDA-regulated manufacturing operations

Benefits

Comprehensive performance-based bonus structure providing direct financial rewards tied to individual and company achievements
Premium healthcare coverage ensuring comprehensive medical support for employees and their families
Robust insurance benefits package offering financial security and risk protection across multiple coverage areas
Strategic retirement programs designed to build long-term financial security with company contributions and investment options
Holistic wellness programs supporting physical and mental health through preventive care and lifestyle support
Recognition-based service and performance awards creating a culture of appreciation and career milestone acknowledgment
Engaging social and recreational activities fostering team building and work-life integration
Location-specific benefit customization ensuring relevance to local market conditions and employee needs

Key Responsibilities

Drive strategic technical direction by determining engineering objectives and making critical decisions that shape project outcomes and organizational capabilities
Ensure operational excellence through comprehensive monitoring and control of engineering work while maintaining adherence to industry standards and company procedures
Lead high-impact capital acquisition initiatives from equipment specification through contract negotiation to installation and validation, directly affecting operational capacity
Conduct advanced analytical work including equipment analysis, experimental testing, and data interpretation to optimize manufacturing processes and drive innovation
Provide technical leadership in process review meetings as lead facilitator or independent reviewer, influencing cross-functional decision-making
Develop organizational capability through coaching and mentoring activities that build technical expertise across the engineering team
Ensure seamless product lifecycle management by providing engineering support for new product and process introductions while maintaining compliance with development procedures
Maintain product and process excellence by ensuring quality standards align with operational and material specifications
Drive component and equipment selection decisions based on comprehensive analysis of specifications, reliability metrics, and regulatory compliance requirements
Collaborate with quality engineering teams to establish robust testing and inspection protocols that ensure product integrity
Lead critical quality initiatives including PFMEA, Control Plan, SOP, and PPAP generation for product transfers and launches
Ensure regulatory compliance through adherence to GMP and safety procedures across all engineering activities
Provide technical oversight through review and approval of validation documentation ensuring regulatory standards are met

Requirements

Education

B.S in Mechanical Engineering or related engineering discipline with 6 or more years' experience; Related masters degree with 2 or more years of experience or PhD may be desirable

Experience

6 or more years' experience with Bachelor's degree, or 2 or more years with Master's degree

Required Skills

Proven track record of working in a team based environment Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams Be open minded with the ability to recognise good ideas Innovative thinker - should be able to envisage new and better ways of doing things Experience in executing complex problem solving techniques related to manufacturing/design technical issues Good instincts and sound judgement for mechanical and structural design Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques Excellent analytical skills, ability to plan, organise and implement concurrent tasks Excellent working knowledge of manufacturing processes, product/process design and engineering materials Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing High level of PC Skills required Excellent attention to detail

Certifications

Certified in validation activities Green or Black Belt 6 Sigma qualifications an advantage Experience in an FDA regulated or regulated industry beneficial
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Sauge AI Market Intelligence

Industry Trends

The medical device industry is experiencing unprecedented growth driven by aging global populations and increased healthcare spending, with companies like Stryker investing heavily in advanced manufacturing operations to meet rising demand for orthopedic, neurotechnology, and surgical equipment. Regulatory complexity in medical devices continues to intensify with stricter FDA and EU MDR requirements, creating high demand for engineers with validation expertise and regulatory compliance experience who can navigate complex approval processes. Digital transformation and Industry 4.0 technologies are revolutionizing medical device manufacturing, with smart factories, predictive maintenance, and data-driven process optimization becoming critical competitive advantages for leading manufacturers.

Role Significance

Typically leads or influences cross-functional teams of 8-15 engineers, technicians, and quality specialists while collaborating with multiple departments including R&D, quality, regulatory, and manufacturing operations
This is a senior technical leadership position with significant autonomy and decision-making authority, positioned to influence strategic technical direction and mentor junior team members while having direct impact on capital investments and process improvements

Key Projects

Leading capital equipment installations and facility expansions worth millions of dollars Driving new product transfer projects from R&D to full-scale manufacturing Implementing process improvement initiatives that enhance manufacturing efficiency and product quality Managing validation projects for FDA and international regulatory submissions

Success Factors

Deep technical expertise in mechanical engineering principles combined with practical manufacturing experience enables effective problem-solving and process optimization in complex medical device production environments. Strong regulatory knowledge and validation experience are critical for ensuring compliance with FDA, ISO 13485, and other international standards that govern medical device manufacturing and quality systems. Leadership and mentoring capabilities are essential for developing team capabilities and driving organizational excellence while managing multiple concurrent projects and competing priorities. Cross-functional collaboration skills enable effective partnership with quality, regulatory, R&D, and operations teams to achieve seamless product launches and process improvements.

Market Demand

High demand driven by Ireland's position as a major medical device manufacturing hub, shortage of experienced engineers with regulatory expertise, and continued expansion of multinational medical device companies in the region

Important Skills

Critical Skills

Design for Manufacturing (DFM) expertise is absolutely essential as it directly impacts product quality, manufacturing efficiency, and cost optimization in high-volume medical device production environments where precision and reliability are paramount. Validation and regulatory compliance knowledge represents critical competencies that cannot be compromised in medical device manufacturing, as these skills ensure patient safety and enable market access for life-saving medical technologies. Advanced problem-solving and analytical skills are fundamental to success in complex manufacturing environments where technical challenges require innovative solutions that balance performance, cost, regulatory requirements, and manufacturing feasibility.

Beneficial Skills

Six Sigma certification provides valuable methodology for systematic process improvement and quality enhancement, offering structured approaches to reducing variation and optimizing manufacturing performance in regulated environments. Advanced data analysis and statistical skills become increasingly important as manufacturing operations embrace digital transformation and data-driven decision making to optimize processes and predict maintenance needs. Project management capabilities and cross-functional leadership skills enhance effectiveness in managing complex capital projects and leading multidisciplinary teams through challenging technical initiatives and regulatory submissions.

Unique Aspects

This role offers exceptional exposure to cutting-edge medical device manufacturing technologies and processes that directly impact patient outcomes and healthcare delivery worldwide.
The position provides unique opportunity to work with advanced validation methodologies and regulatory frameworks specific to life-critical medical devices, offering specialized expertise that is highly valued in the industry.
Stryker's commitment to innovation and substantial R&D investments create opportunities to work on breakthrough medical technologies and next-generation manufacturing processes.
The hybrid work arrangement combined with international travel opportunities provides exposure to global operations and cross-cultural collaboration within a multinational organization.

Career Growth

3-5 years for progression to management roles or principal technical positions, depending on performance, additional leadership development, and organizational opportunities

Potential Next Roles

Engineering Manager or Director positions overseeing larger engineering teams and broader operational responsibilities Principal Engineer roles focusing on advanced technology development and strategic technical initiatives Operations Manager positions with P&L responsibility for manufacturing facilities Regulatory Affairs or Quality leadership roles leveraging validation and compliance expertise

Company Overview

Stryker

Stryker is a Fortune 500 medical technology corporation with over $17 billion in annual revenue, recognized as one of the world's leading manufacturers of orthopedic implants, surgical equipment, and neurotechnology devices serving healthcare providers globally.

Stryker holds dominant market positions in orthopedics and surgical equipment with strong competitive advantages through innovation, comprehensive product portfolios, and established relationships with healthcare institutions worldwide.
Ireland serves as a critical manufacturing and distribution hub for Stryker's European operations, with significant investments in advanced manufacturing facilities and a growing engineering workforce supporting global product development and production.
Stryker maintains a performance-driven culture emphasizing innovation, quality excellence, and customer focus, with strong emphasis on employee development, cross-functional collaboration, and maintaining the highest standards of regulatory compliance and patient safety.
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