Staff Engineer Advanced Operations

Stryker Group; Cork; On-site; EUR 54,000 - 90,000; Full time

Job summary

Stryker is seeking a Senior Manufacturing Process Development Engineer to drive NPI delivery and manufacturing process development across launches. You will coach engineers, apply Six Sigma and data-driven methods, and ensure robust process capability and GMP compliance.

Reporting into the NPI/Manufacturing team, you will lead PFMEA, Control Plans, PPAP and validation activities, while partnering with tooling and equipment suppliers to meet cost, quality and schedule targets.

Qualifications

• B.S in Mechanical / Manufacturing / Precision Engineering or related engineering discipline.
• Strong knowledge of Six Sigma methodologies and problem solving.
• Experience in FDA-regulated environments is beneficial.
• Ability to interpret complex engineering drawings and apply GD&T.
• Experience with DOE and capability studies.

Responsibilities

• Own and lead process development workstreams across NPI initiatives.
• Coach engineers on structured problem solving and lean practices.
• Conduct DOE experiments to optimize parameters.
• Lead PFMEA, Control Plans, PPAP and validation documentation.
• Partner with suppliers to define and validate manufacturing solutions.

Skills

Manufacturing process development

Six Sigma / Lean

Data-driven decision making

Cross-functional collaboration

Process capability & statistics

Problem solving

Education

B.S in Mechanical / Manufacturing / Precision Engineering or related field

Tools

Geometric Dimensioning and Tolerancing (GD&T)

Job description

Job description

Work Flexibility: Hybrid

Position Summary

Responsible for creating a work practice, environment and culture that elevates NPI Delivery, Technical Rigour and Manufacturing Process Development throughout the lifecycle of launching new products.

Role success will be gauged by this individual’s contribution in coaching the engineering team to effectively meet and/or exceed new product metrics including product cost, process performance and time to market.

Key Areas of Responsibility

• Own one or more critical manufacturing process development workstreams while supporting the technical direction, objectives, and success criteria for related workstreams across the project.
• Ensure technical rigour, governance, and appropriate engineering discipline are applied across own and adjacent process workstreams,
• Make informed, data-driven technical decisions across multiple manufacturing process development workstreams.
• Monitor, challenge and support process development progress ensuring appropriate application of Engineering best practices, six sigma methodologies, statistical analysis, company procedures and policies.
• Coach and mentor other Engineers on NPI delivery, manufacturing process development, engineering best practices, structured problem solving, Six Sigma, and other function-related topics.
• Conduct experimental testing and DOEs to determine optimal and robust operating parameters.
• Lead manufacturing process development reviews, providing technical challenge, guidance, and direction to ensure high quality engineering outputs.
• Partner with tooling, fixturing and equipment suppliers to define, develop, test, optimise and validate manufacturing solutions that meet technical, quality, cost and scalability requirements.
• Lead capital acquisition activity from identifying potential suppliers, conducting initial proof of principles, specifying equipment requirements, testing, defining acceptance criteria, and technical approval of equipment readiness.
• Contribute to process technology roadmap activities and drive innovation in manufacturing technologies ensuring alignment with future product launches.
• Successfully collaborate with cross functional project team members to achieve project, product and operational success.
• Lead or provide technical input into PFMEA, Control Plans, SOPs, PPAP documentation, validation documentation, and other launch deliverables associated with new product and process introductions.
• Complete capability studies for process control and generate subsequent production documentation ensuring that all activities are completed and documented in accordance with Stryker new product development procedures.
• Lead and/or support process qualification activities, including IQ, OQ, and PQ for manual, semi-automated, and automated manufacturing processes. Review and approve validation protocols, reports, and supporting documentation as required.
• Provide engineering support for new product and process introductions. Provide training to manufacturing team members and other Engineers.
• Promote a culture of technical excellence, structured problem solving, knowledge sharing, and continuous improvement across the engineering team.
• Lead and/or provide technical input into the Stryker design transfer process, ensuring robust manufacturing readiness and that internal and external supply chains are set up for successful launch, scale-up, and sustained performance.
• Ensure adherence to GMP and safety procedures.
• All other duties as assigned.

Qualifications Knowledge Skills

• B.S in Mechanical / Manufacturing / Precision Engineering or related engineering discipline with 4 or more years’ industry experience.
• Demonstrated passion for taking on complex technical challenges where there are no obvious answers, and for bringing ideas from concept through to successful launch
• Excellent working knowledge of manufacturing processes, inspection equipment, materials, and process design.
• Strong understanding of Design for Manufacture, Design for Inspection, and Design for Assembly principles.
• Ability to read and interpret complex engineering drawings, with strong knowledge of geometric dimensioning and tolerancing.
• Proficient in the application of statistical analysis to manufacturing process development, process capability, and problem solving.
• Excellent interpersonal and communication skills, with the ability to clearly express technical ideas, influence cross-functional stakeholders, collaborate effectively to achieve project goals, and remain open-minded to alternative approaches and good ideas.
• Innovative thinker with the ability to identify, develop, and implement new and improved ways of working. A continuous improvement and Lean Six Sigma mindset is advantageous.
• Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.
• Strong engineering judgement, with sound instincts for mechanical, manufacturing, and structural design considerations.
• Excellent analytical skills, ability to accurately plan, organise and implement concurrent tasks.
• Experience working in an FDA-regulated or similarly regulated industry is beneficial

#IJ

Ireland Pay Ranges

• Ireland: €54,000 - €90,000 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.