Senior Staff Engineer, Advanced Operations – Biomaterials

Work Flexibility: Hybrid or Onsite<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>Job Title:</b> Senior Staff Engineer, Advanced Operations – Biomaterials<br /><b>Job Family:</b> Engineering – Advanced Operations / Manufacturing Engineering<br /><b>Reports To:</b> Manager / Senior Manager/Director, Advanced Operations</p><h2></h2><h2>Position Summary</h2><p>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.</p><p></p><h2>Key Responsibilities</h2><h3>Technical Leadership and Project Execution</h3><ul><li><p>Lead Advanced Operations deliverables for biomaterials-focused programmes from concept through transfer/launch.</p></li><li><p>Define technical objectives, project plans, and deliverables; drive execution to meet programme milestones.</p></li><li><p>Coordinate cross-functional activity across R&amp;D, Quality, Operations, Supply Chain, Regulatory, and external partners.</p></li><li><p>Provide technical direction and decision-making on process capability, material performance, and manufacturability.</p></li></ul><h3>Supplier Interface and External Execution (Essential)</h3><ul><li><p>Lead day-to-day technical interaction between the internal project team and external suppliers.</p></li><li><p>Drive supplier process development, manufacturing readiness, and issue resolution using structured problem-solving.</p></li><li><p>Conduct/lead supplier capability assessments, technical reviews, and readiness reviews; ensure alignment on deliverables and timing.</p></li><li><p>Own supplier-related project actions, ensuring clear accountability, escalation, and closure.</p></li></ul><h3>Risk Management (Essential)</h3><ul><li><p>Proactively identify technical, manufacturing, quality, and supply risks; develop mitigation plans and drive closure.</p></li><li><p>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.</p></li><li><p>Ensure critical-to-quality characteristics, process parameters, and inspection strategies are defined and controlled.</p></li></ul><h3>APQP / PPAP Leadership to Closure (Essential)</h3><ul><li><p>Lead APQP execution and PPAP activities end-to-end for supplier-provided biomaterials components/processes.</p></li><li><p>Drive completion, review, and closure of PPAP elements, ensuring documentation quality and on-time submission.</p></li><li><p>Ensure robust evidence of process capability and control (e.g., process flow, PFMEA, control plan, MSA, capability studies, validation evidence, material certifications as applicable).</p></li><li><p>Coordinate internal approvals and supplier resubmissions; drive corrective actions and preventive actions to closure.</p></li></ul><h3>Process Development, Validation, and Transfer</h3><ul><li><p>Define and execute process development strategy, including process window characterization and capability improvement.</p></li><li><p>Lead or support equipment/process validation activities (e.g., IQ/OQ/PQ as applicable) and ensure compliance to quality system requirements.</p></li><li><p>Support transfer of processes to manufacturing sites, ensuring documentation, training, and sustainment plans are in place.</p></li></ul><h3>Continuous Improvement and Technical Excellence</h3><ul><li><p>Apply statistical and engineering methods to analyze data, identify root causes, and improve process performance.</p></li><li><p>Champion robust engineering standards, documentation discipline, and “right-first-time” execution.</p></li><li><p>Mentor engineers and peers on supplier management, PPAP execution, validation, and risk management best practices.</p></li></ul><h3>Quality and Compliance</h3><ul><li><p>Ensure activities are performed in alignment with applicable quality systems, regulatory expectations, and EHS requirements.</p></li><li><p>Partner with Quality to establish appropriate material/component testing, inspection, and acceptance criteria.</p></li></ul><p></p><h2>Minimum Qualifications (Required)</h2><ul><li><p>Bachelor’s degree in Mechanical Engineering, Materials Science/Engineering, Chemical Engineering, Biomedical Engineering, or related discipline.</p></li><li><p>Significant relevant industry experience (typically 6&#43; years; advanced degree may reduce years of required experience).</p></li><li><p>Demonstrated track record leading supplier-facing technical projects with clear delivery against quality and schedule.</p></li><li><p>Proven, hands-on experience leading APQP/PPAP activities and driving PPAP closure with suppliers.</p></li><li><p>Strong capability in risk identification, mitigation planning, and structured problem-solving (8D/A3 or similar).</p></li><li><p>Working knowledge of manufacturing process development, validation/verification, and statistical tools (MSA, Cp/Cpk, DOE).</p></li><li><p>Strong communication and stakeholder management skills; able to lead effectively in a matrix environment.</p></li><li><p>Self-driven, organized, and comfortable operating with ambiguity while maintaining disciplined execution.</p></li></ul><h2>Preferred Qualifications</h2><ul><li><p>Experience in a regulated industry (medical devices strongly preferred).</p></li><li><p>Biomaterials experience (e.g., polymers, coatings, adhesives, bioresorbables, material characterization, compatibility considerations).</p></li><li><p>Six Sigma Green Belt/Black Belt or equivalent continuous improvement training.</p></li><li><p>Experience leading capital equipment specification, procurement support, installation, and validation.</p></li></ul><p></p><h2>Additional Information</h2><ul><li><p>Role may require visits to supplier facilities and manufacturing sites to support development, validation, and issue resolution.</p></li><li><p>All other duties as assigned.</p></li></ul><p><b>Travel:</b> Up to 25% (domestic/international) to suppliers and manufacturing sites as required .</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: Up to 25%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>