Medical Device & Combination Product; MDCP) Engineer

Position: Medical Device & Combination Product (MDCP) Engineer
Job Description
Do you have experience with medical devices, automation, and process validation in a regulated environment? Join an innovative team at one of the largest pharmaceutical manufacturing companies in the Netherlands. At our Haarlem site, we have an exciting opportunity for a Medical Device & Combination Product (MDCP) Engineer.

Welcome to our team
Are you ready to make a global impact in medical device development? As a MDCP Engineer in Device Development & Technology (DD&T), you will drive innovative medical devices and combination products through development, qualification, commercialization, and long-term sustainment. Working in a highly collaborative environment, you will partner with Manufacturing, Quality, Operations, Product Development, Regulatory Affairs, Procurement, and external suppliers to drive innovation, technical excellence, and continuous improvement across a global product portfolio.

Purpose of the role
As a Medical Device & Combination Product (MDCP) Engineer, you will support the development, technology transfer, commercialization, and lifecycle management of medical devices and combination products, with a particular focus on autoinjectors, pre-filled syringes, and co-packed products. You will apply your expertise in design controls, device risk management, process development, process validation, and automation to solve complex technical challenges and support compliant manufacturing operations.

This role requires strong problem-solving skills, the ability to manage competing priorities, and effective communication with a broad range of stakeholders. You will work independently on defined projects while collaborating with global and site-based teams to drive investigations, process improvements, and strategic initiatives. Key stakeholders include packaging technology teams, quality organizations, manufacturing operations, product development, regulatory affairs, procurement, and external suppliers.

Tasks And Responsibilities

Facilitate technology and design transfer of medical devices and combination products from development through commercialization.

Contribute to the design, build, and validation of semi-automated and fully automated autoinjector assembly systems and combination product kit assembly lines.

Own the technical aspects of investigations related to the qualification and commercial operation of MDCP assembly systems.

Support root cause analyses, CAPA activities, deviation investigations, and troubleshooting efforts.

Utilize device risk management tools (d/pFMEA, QRA, OER, etc.) to support the development and maintenance of device and combination product risk management files.

Demonstrate strong communication skills by integrating input from multiple stakeholders and effectively communicating decisions to key stakeholders and sponsors.

Actively seek feedback to ensure customer and stakeholder needs remain central to decision-making and expectations.

What We Ask

BS degree or higher in Engineering (Mechanical, Biomedical, Chemical, Materials, or similar).

3+ years of experience in medical devices or combination products (e.g., autoinjectors, pre-filled syringes, MDCPs).

Experience with manufacturing equipment, automation, DFM, and qualification activities (IQ/OQ/PQ).

Knowledge of root cause analysis, structured problem-solving, and process improvement.

Experience with design transfer, tech transfer, process validation, and scale-up.

Strong understanding of risk management (FMEA, hazard analysis, control strategies).

Experience with change control, deviation management, and QMS documentation.

Cross-functional project management experience in international environments.

Excellent communication skills in English;
Dutch is a plus.

Preferred 5+ years in medical device/pharma/biotech, with experience in design control, verification testing, TMV, metrology, and automated assembly/manufacturing support.

What We Offer
Working at our organization means collaborating to improve health in an international environment alongside dedicated colleagues. You will have every opportunity to develop yourself and show who you are. In addition, you can expect an attractive benefits package, including

Competitive salary

35.5 vacation days per year

8% holiday allowance and a 3% year-end bonus

Excellent pension plan

High-quality company restaurant offering fresh and healthy options every day

On-site sports facilities with classes such as boxing, Zumba, and Pilates

Excellent coffee prepared by a professional barista

Game room with a pool table and table tennis table

Contribution toward your personal gym or sports subscription

Mental well-being support through Lyra Health for you and your family members

Access to a dedicated prayer and meditation room

Required Skills
Computer Efficiency, Concurrent Engineering, Creativity, Cross-Functional Project Management, Root Cause Identification, Root Cause Investigations, Summary Reports, Sustainability, Teamwork

Employee Status
Regular

Flexible Work Arrangements
Hybrid

Job Posting End…