Senior Staff Engineer, Advanced Operations – Biomaterials

Job Title: Senior Staff Engineer Advanced Operations Biomaterials
Job Family: Engineering Advanced Operations / Manufacturing Engineering
Reports To: Manager / Senior Manager/Director Advanced Operations

Position Summary

The 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)

• Bachelors 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 .