Senior Staff Engineer, Advanced Operations – Biomaterials page is loaded## Senior Staff Engineer, Advanced Operations – Biomaterialslocations: Carrigtwohill, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: R******Work Flexibility: Hybrid or Onsite**Job Title:** Senior Staff Engineer, Advanced Operations – Biomaterials **Job Family:** Engineering – Advanced Operations / Manufacturing Engineering **Reports To:** Manager / Senior Manager/Director, Advanced Operations## ## Position SummaryThe Senior Staff Engineer, Advanced Operations – Biomaterials is responsible for leading supplier-facing technical projects and industrialization activities in the biomaterials space.
This role provides technical leadership across cross-functional teams to deliver robust manufacturing processes and supply readiness that meet programme requirements for quality, cost, and schedule.
The successful candidate will be self-driven, strong in risk identification and mitigation, and experienced in leading APQP/PPAP deliverables through to closure with suppliers and internal stakeholders.
## Key Responsibilities### Technical Leadership and Project Execution* Lead Advanced Operations deliverables for biomaterials-focused programmes from concept through transfer/launch.
* Define technical objectives, project plans, and deliverables; drive execution to meet programme milestones.
* Coordinate cross-functional activity across R&D, Quality, Operations, Supply Chain, Regulatory, and external partners.
* Provide technical direction and decision-making on process capability, material performance, and manufacturability.
### Supplier Interface and External Execution (Essential)* Lead day-to-day technical interaction between the internal project team and external suppliers.
* Drive supplier process development, manufacturing readiness, and issue resolution using structured problem-solving.
* Conduct/lead supplier capability assessments, technical reviews, and readiness reviews; ensure alignment on deliverables and timing.
* Own supplier-related project actions, ensuring clear accountability, escalation, and closure.
### Risk Management (Essential)* Proactively identify technical, manufacturing, quality, and supply risks; develop mitigation plans and drive closure.
* Lead and/or facilitate risk management activities (e.g., DFMEA/PFMEA inputs, process risk assessments) and ensure risks are reflected in control strategies and validation plans.
* Ensure critical-to-quality characteristics, process parameters, and inspection strategies are defined and controlled.
### APQP / PPAP Leadership to Closure (Essential)* Lead APQP execution and PPAP activities end-to-end for supplier-provided biomaterials components/processes.
* Drive completion, review, and closure of PPAP elements, ensuring documentation quality and on-time submission.
* Ensure robust evidence of process capability and control (e.g., process flow, PFMEA, control plan, MSA, capability studies, validation evidence, material certifications as applicable).
* Coordinate internal approvals and supplier resubmissions; drive corrective actions and preventive actions to closure.
### Process Development, Validation, and Transfer* Define and execute process development strategy, including process window characterization and capability improvement.
* Lead or support equipment/process validation activities (e.g., IQ/OQ/PQ as applicable) and ensure compliance to quality system requirements.
* Support transfer of processes to manufacturing sites, ensuring documentation, training, and sustainment plans are in place.
### Continuous Improvement and Technical Excellence* Apply statistical and engineering methods to analyze data, identify root causes, and improve process performance.
* Champion robust engineering standards, documentation discipline, and "right-first-time" execution.
* Mentor engineers and peers on supplier management, PPAP execution, validation, and risk management best practices.
### Quality and Compliance* Ensure activities are performed in alignment with applicable quality systems, regulatory expectations, and EHS requirements.
* Partner with Quality to establish appropriate material/component testing, inspection, and acceptance criteria.
## Minimum Qualifications (Required)* Bachelor's degree in Mechanical Engineering, Materials Science/Engineering, Chemical Engineering, Biomedical Engineering, or related discipline.
* Significant relevant industry experience (typically 6+ years; advanced degree may reduce years of required experience).
* Demonstrated track record leading supplier-facing technical projects with clear delivery against quality and schedule.
* Proven, hands-on experience leading APQP/PPAP activities and driving PPAP closure with suppliers.
* Strong capability in risk identification, mitigation planning, and structured problem-solving (8D/A3 or similar).
* Working knowledge of manufacturing process development, validation/verification, and statistical tools (MSA, Cp/Cpk, DOE).
* Strong communication and stakeholder management skills; able to lead effectively in a matrix environment.
* Self-driven, organized, and comfortable operating with ambiguity while maintaining disciplined execution.
## Preferred Qualifications* Experience in a regulated industry (medical devices strongly preferred).
* Biomaterials experience (e.g., polymers, coatings, adhesives, bioresorbables, material characterization, compatibility considerations).
* Six Sigma Green Belt/Black Belt or equivalent continuous improvement training.
* Experience leading capital equipment specification, procurement support, installation, and validation.
## Additional Information* Role may require visits to supplier facilities and manufacturing sites to support development, validation, and issue resolution.
* All other duties as assigned.
**Travel:** Up to 25% (domestic/international) to suppliers and manufacturing sites as required .
Travel Percentage: Up to 25%
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