Senior MDCP Engineer: Autoinjectors & Device Innovation

MSD Netherlands; Haarlem; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

35.5 vacation days per year

8% holiday allowance and a 3% year-end

Excellent pension plan

On-site sports facilities

Company restaurant

On-site coffee and barista

Game room with pool and table tennis

Personal gym/subscription support

Lyra Health mental well-being support

Prayer and meditation room

Job summary

MSD Netherlands in Haarlem is seeking a Medical Device & Combination Product (MDCP) Engineer to drive development, transfer, and lifecycle management of medical devices and combination products, with a focus on autoinjectors, pre-filled syringes, and co-packed products. You will apply design controls, risk management, process development, and automation to deliver compliant manufacturing operations.

You will collaborate with Manufacturing, Quality, Operations, Product Development, Regulatory

Qualifications

• 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.

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 kit lines.
• Own the technical aspects of investigations related to qualification and commercial operation of MDCP assembly systems.
• Support root cause analyses, CAPA activities, deviation investigations, and troubleshooting.
• 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.

Skills

Computer Efficiency

Concurrent Engineering

Creativity

Cross-Functional Project Management

Root Cause Identification

Root Cause Investigations

Summary Reports

Sustainability

Teamwork

Education

Bachelor’s degree in Engineering

Job description

MSD Netherlands in Haarlem is seeking a Medical Device & Combination Product (MDCP) Engineer to drive development, transfer, and lifecycle management of medical devices and combination products, with a focus on autoinjectors, pre-filled syringes, and co-packed products. You will apply design controls, risk management, process development, and automation to deliver compliant manufacturing operations.

You will collaborate with Manufacturing, Quality, Operations, Product Development, Regulatory