Director of Engineering, Synthetics

Leiden Bio Science Park; Nijmegen; On-site; EUR 150,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well‑being reimbursement

Insurance plans

Service awards

Holiday allowance

Job summary

Leiden Bio Science Park is seeking a senior engineering leader to oversee design, scale‑up, and lifecycle support of medical device manufacturing processes. You will own the capital portfolio and drive technology transformations in automation, digital manufacturing, and Industry 4.0.

You will lead a team across process, equipment, automation, and facilities, partnering with R&D, Quality, Regulatory, and Supply Chain to ensure safe, compliant, and cost‑competitive production.

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.

Responsibilities

• Lead a multidisciplinary engineering organization responsible for design, scale‑up, industrialization, and lifecycle support of manufacturing processes for medical device products.
• Own the engineering strategy, capital investment portfolio, and technology transformation to deliver safe, compliant, reliable, and cost‑competitive supply.
• Lead complex, cross‑functional engineering programs supporting capacity expansion, NPI, technology transfer, scale‑up, and product lifecycle management.
• Establish robust program governance with integrated plans, milestones, risk registers, and stage‑gate reviews.
• Proactively identify and mitigate technical, supply, and schedule risks; provide concise, data‑driven updates to senior leadership on program status.

Job description

Leads a multidisciplinary engineering organization responsible for the design, scale-up, industrialization, and lifecycle support of manufacturing processes for medical device products, with a focus on Synthetic products.

Owns the engineering strategy, capital investment portfolio, and technology transformation to deliver safe, compliant, reliable, and cost-competitive supply.

Reports to the Senior Director, Global Technical Operations – Biosurgery and partners closely with R&D, Quality, Regulatory, Supply Chain, Finance, and external partners.

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.

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.

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; escalat…

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.

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.

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.

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.

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.

Hands‑on expertise in powder processing technologies (milling, blending, granulation, spray drying, powder filling, containment) is a plus.

Direct experience with medical products is a plus.

Experience with hemostats, biosurgery, or other absorbable/biologic medical products is a plus.

Experience managing external manufacturing partners, suppliers, and engineering contractors in a global environment is a plus.

Project Management Professional (PMP), Lean Six Sigma, or equivalent certification is a plus.

Annual bonus with set target (% of pay) depending on pay grade / location, based on the employees’ and companies’ performance of the previous calendar year.

Vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave.

Well‑being reimbursement, programs for financial, physical and mental health.

Service anniversary and recognition awards.

Subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

The annual base pay includes an 8% holiday allowance.

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 with relevant people leadership experience.