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%

Senior Staff Engineer, Advanced Operations – Biomaterials

Job Description