Director of Engineering, Synthetics

The Director owns the engineering strategy and capital investment portfolio, drives complex cross-functional programs from concept through validation and commercial launch, and leads technology transformation to deliver safe, compliant, reliable, and cost-competitive supply. Reporting to the Senior Director, Global Technical Operations – Biosurgery, this leader builds high-performing teams and partners closely with R&D, Quality, Regulatory, Supply Chain, Finance, and external partners.

Team Leadership & Talent Development

• Lead, coach, and develop a team of engineering managers, engineers, and technical specialists across process, equipment, automation, and facilities disciplines.
• Set clear goals, priorities, and accountability; build organizational capability through hiring, succession planning, and targeted development.
• Foster an inclusive, purpose-driven culture that encourages technical excellence, collaboration, and continuous improvement.
• Provide leadership across sites and functions, influencing senior stakeholders to align priorities and resources.

Capital Investments

• Own the multi-year engineering capital plan, including capacity expansion, new manufacturing lines, equipment replacement, and facility upgrades.
• Develop and present business cases and capital appropriation requests, including scope, cost, schedule, risk, and return on investment.
• Lead execution of projects from concept and design through installation, commissioning, qualification and handover to operations.
• Manage budgets, forecasts, and spend in partnership with Finance; ensure projects deliver on committed cost, schedule, and performance targets.
• Select and manage equipment vendors, engineering firms, and contract manufacturers/partners.

Program Management

• Lead complex, cross-functional engineering programs supporting capacity expansion, New Product Introduction (NPI), technology transfer, scale-up, and product lifecycle management.
• Establish robust program governance, including integrated plans, milestones, risk registers, and stage-gate reviews.
• Proactively identify and mitigate technical, supply, and schedule risks; escalate issues with clear options and recommendations.
• Provide concise, data-driven updates to senior leadership on program status, resources, and key decisions.
• Support base business manufacturing by partnering with site operations to sustain supply continuity, resolve technical and process issues, and deliver lifecycle, cost-improvement, and reliability projects.
• Develop project and program management skills across the engineering organization through coaching, standard tools and templates, and hands-on program leadership opportunities.
• Align engineering priorities with R&D, Quality, Regulatory, Supply Chain, and Commercial roadmaps.

Technology Transformation

• Define and execute the engineering technology roadmap, including automation, digital manufacturing, data analytics, and Industry 4.0 and AI capabilities.
• Evaluate, pilot, and scale new process technologies to improve yield, capacity, quality, and cost.
• Champion process robustness through Design of Experiments (DoE), Process Analytical Technology (PAT), and advanced process control.
• Drive standardization of equipment, processes, and engineering practices across sites and external partners.

Combination Products & Powder Processing

• Provide technical leadership for medical device and drug-device / biologic-device combination product manufacturing processes.
• Lead development, scale-up, and optimization of powder processes, including milling, blending, granulation, drying, particle-size control, powder filling, and containment.
• Address powder-specific challenges such as flowability, segregation, moisture sensitivity, dust control, and operator safety.
• Ensure process and equipment design supports sterility assurance, contamination control, and cleanroom requirements where applicable.
• Partner with R&D and external partners to transfer powder and combination product technologies into robust commercial manufacturing.

Quality, Compliance & Safety

• Ensure all engineering activities comply with applicable cGMP requirements.
• Lead or support process validation, change control, risk management (pFMEA), and investigations / CAPA with sound engineering root-cause analysis.
• Support regulatory submissions and inspections with technical documentation and subject-matter expertise.
• Uphold Environmental, Health & Safety (EHS) standards, including combustible dust and potent-compound handling where relevant.

Qualifications

Bachelor's degree in Chemical, Mechanical, Biomedical, Materials, or related Engineering discipline is required. Master's degree, MBA, or PhD is preferred.

Minimum of 10 years of engineering experience in medical device, pharmaceutical, or combination product manufacturing with relevant people leadership experience.

• Proven track record leading capital investment projects, including business case development, budget ownership, and delivery of new lines or facilities.
• Demonstrated success leading complex, cross-functional programs (NPI, technology transfer, or scale-up) to on-time, on-budget outcomes.
• Experience leading technology transformation, such as automation, digitalization, or introduction of new process platforms.
• Working knowledge cGMP requirements, including process validation and risk management.

Preferred: Hands-on expertise in powder processing technologies (milling, blending, granulation, spray drying, powder filling, containment). Experience with hemostats, biosurgery, or other absorbable/biologic medical products. Experience managing external manufacturing partners, suppliers, and engineering contractors in a global environment. Project Management Professional (PMP), Lean Six Sigma, or equivalent certification.

Key Competencies

• Strategic thinking with the ability to translate vision into executable plans.
• Strong financial acumen and data-driven decision-making.
• Executive presence with clear, concise communication to senior leadership.
• Ability to influence without authority across a global matrix organization.
• Bias for action, accountability, and a continuous-improvement mindset.
• Willingness to travel up to 30%, domestically and internationally.