Director of Engineering, Synthetics
About The Position
The Director of Engineering, Global Technical Operations leads a multidisciplinary engineering organization responsible for the design, scale-up, industrialization, and lifecycle support of manufacturing processes for medical device products. The role focuses particularly on Synthetic products and processes while also supporting base business manufacturing. The Director owns the engineering strategy and capital investment portfolio, leads cross-functional programs from concept through validation and commercial launch, and drives technology transformation to deliver safe, compliant, reliable, and cost-competitive supply. The position reports to the Senior Director, Global Technical Operations – Biosurgery and partners closely with R&D, Quality, Regulatory, Supply Chain, Finance, and external partners. The Director leads and develops engineering managers, engineers, and technical specialists across process, equipment, automation, and facilities disciplines. The role sets priorities and accountability, builds organizational capability, and fosters an inclusive culture of technical excellence and continuous improvement. The role owns the multi-year capital plan and oversees business cases, budgets, vendors, and project delivery through installation, commissioning, qualification, and operational handover. It leads complex programs in capacity expansion, new product introduction, technology transfer, scale-up, and lifecycle management, while supporting site operations and manufacturing continuity. The Director defines the engineering technology roadmap, including automation, digital manufacturing, analytics, Industry 4.0, and AI. It provides technical leadership for combination-product manufacturing and powder processing, and ensures engineering work meets applicable cGMP, validation, risk-management, regulatory, and EHS expectations.
Requirements
- Bachelor's degree in Chemical, Mechanical, Biomedical, Materials, or a related engineering discipline.
- At least 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 such as 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 of cGMP requirements, including process validation and risk management.
- Strategic thinking and ability to translate vision into executable plans.
- Strong financial acumen and data-driven decision-making.
- Clear, concise communication and executive presence with 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.
Nice To Haves
- Master's degree, MBA, or PhD.
- Hands-on expertise in powder processing technologies, including milling, blending, granulation, spray drying, powder filling, and containment.
- Direct experience with medical products.
- Experience with hemostats, biosurgery, or other absorbable or 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.
Responsibilities
- Lead, coach, and develop engineering managers, engineers, and technical specialists across process, equipment, automation, and facilities disciplines.
- Set team goals, priorities, and accountability; build organizational capability through hiring, succession planning, and targeted development.
- Foster an inclusive, purpose-driven culture focused on technical excellence, collaboration, and continuous improvement.
- Influence senior stakeholders across sites and functions to align priorities and resources.
- Own the multi-year engineering capital plan for 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 capital projects from concept and design through installation, commissioning, qualification, and handover to operations.
- Manage budgets, forecasts, and spending with Finance, ensuring projects meet cost, schedule, and performance targets.
- Select and manage equipment vendors, engineering firms, contract manufacturers, and other partners.
- Lead cross-functional engineering programs supporting capacity expansion, NPI, technology transfer, scale-up, and product lifecycle management.
- Establish program governance, including integrated plans, milestones, risk registers, and stage-gate reviews.
- Identify and mitigate technical, supply, and schedule risks; escalate issues with recommendations and options.
- Provide senior leadership with concise, data-driven updates on program status, resources, and decisions.
- Partner 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, templates, and practical leadership opportunities.
- Align engineering priorities with R&D, Quality, Regulatory, Supply Chain, and Commercial roadmaps.
- Define and execute the engineering technology roadmap, including automation, digital manufacturing, data analytics, Industry 4.0, and AI capabilities.
- Evaluate, pilot, and scale process technologies to improve yield, capacity, quality, and cost.
- Promote process robustness using Design of Experiments, Process Analytical Technology, and advanced process control.
- Drive standardization of equipment, processes, and engineering practices across sites and external partners.
- Provide technical leadership for medical device and drug-device or biologic-device combination-product manufacturing.
- Lead development, scale-up, and optimization of powder processes, including milling, blending, granulation, drying, particle-size control, powder filling, and containment.
- Address powder-process challenges such as flowability, segregation, moisture sensitivity, dust control, and operator safety.
- Ensure process and equipment designs support sterility assurance, contamination control, and cleanroom requirements where applicable.
- Partner with R&D and external partners to transfer powder and combination-product technologies into commercial manufacturing.
- Ensure engineering activities comply with applicable cGMP requirements.
- Lead or support process validation, change control, risk management, and investigations/CAPA using engineering root-cause analysis.
- Support regulatory submissions and inspections with technical documentation and subject-matter expertise.
- Uphold EHS standards, including combustible-dust and potent-compound handling requirements where relevant.
Benefits
- Annual bonus with a target based on pay grade and location, with actual amounts based on employee and company performance, or sales commissions.
- Vacation days.
- Parental leave for a minimum of 12 weeks.
- Bereavement leave.
- Caregiver leave.
- Volunteer leave.
- Well-being reimbursement.
- Programs supporting financial, physical, and mental health.
- Service anniversary and recognition awards.
- Access to insurance plans for employees and, in some locations, eligible dependents, subject to plan terms.
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What This Job Offers
Job Type
Full-time
Career Level
Director
