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 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

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address: . You can only apply through our website.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.