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 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)

• 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%