Senior MDCP Engineer

Senior Engineer MDCP – Packaging Technical Operations Are you passionate about bringing new products to life, ensuring seamless technical execution and supply to our patients? We’re looking for a driven and collaborative Senior Engineer MDCP to join our Packaging Technical Operations team in Haarlem. In this role, you’ll be at the heart of our mission as a launch site for new products, leading technical readiness for our new MDCP products with precision and purpose.

Welcome to our team! Technical Operations at the Haarlem site is responsible for design & technology transfer of new products into the site, component support, and execution of capital projects to install or upgrade device assembly & packaging line capabilities aligned with new product needs.

Purpose of the position We are looking for a Senior MDCP Engineer to join our Haarlem Packaging Technical Operations Team. You will be the key contact for medical device and combination product (MDCP) activities, supporting design, tech transfer, and sustainment at the site. This role includes ownership of MDCP related technical documentation to ensure compliance and quality. Ideal candidates have strong experience in design controls, device risk management, process validation, problem solving, and MDCP platforms like prefilled syringes and autoinjectors. You’ll thrive in a fast‑paced environment, managing priorities effectively while communicating clearly with stakeholders to deliver robust technical solutions.

Primary Responsibilities

Facilitate design & technology transfer from development to launch for MDCPs.

Lead or support device risk management for MDCP product introductions or changes, collaborating with stakeholders.

Apply design control expertise to create value‑added solutions for medical devices and combination products.

Lead technical investigations for commercial MDCP products.

Collaborate on validation strategies for MDCPs following regulatory guidelines.

Maintain compliance of technical documentation related to MDCPs and support regulatory filings and inspections.

Demonstrate inclusive communication, solicit stakeholder feedback, and ensure decisions prioritize patient safety and customer needs.

Ensure all activities comply with company safety, quality, and regulatory procedures.

Your profile

Required BS degree or higher in Engineering or related field; preferred in Mechanical, Chemical, Biomedical, or Materials Engineering.

Minimum 5 years’ experience in medical device and combination product manufacturing, assembly, and packaging.

Proven technical leadership in medical device/combination product commercialization and operations support.

Experience with autoinjectors, prefilled syringes, drug‑delivery systems, and related components.

Knowledge of deviation management, change control, process scale‑up, validation, and equipment qualification.

Experience implementing robust control strategies for MDCP manufacturing including device assembly and packaging operations.

Proficient in project management, MDCP regulations, and generating design controls lifecycle documentation.

Preferred Experience in ISO 13485, ISO 14971, and supporting regulatory inspections.

What we offer

Competitive salary and a 3% year‑end bonus.

35.5 days of leave.

Attractive collective health care insurance package with considerable reduction rates.

Solid Pension Plan.

Incentive Plan.

Travel allowance for commuting.

On‑site sports facilities.

Numerous training, coaching and e‑learning modules for long‑term job opportunities and development.

For questions about this vacancy Please send an email including the vacancy number and job title to the following email address: RecruitmentNL@MSD.com

Required Skills

Change Management

Collaborative Development

Data Analysis

Deviation Management

Equipment Qualification

Facility Management

Good Manufacturing Practices (GMP)

Manufacturing

Medical Devices

Packaging Processes

Project Management

Regulatory Inspections

Team Leadership

Technology Transfer

Troubleshooting

Vaccine Manufacturing

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