Sr. MDCP Tech Transfer Engineer

Job Description

Welcome to the team

Are you ready to make a global impact in the field of medical devices? Join our Device Development and Technology (DD&T) Organization as a Senior Engineer and play a pivotal role in shaping the future of medical devices and combination products worldwide. As a vital team member, you’ll collaborate closely with diverse stakeholders—including Manufacturing, External Partners, R&D, Quality Assurance, Operations, Product Development, Regulatory Affairs, Procurement, and key suppliers—to drive innovation, commercialization, and continued success across our global portfolio.

Purpose of the role

Candidates will need experience with medical devices and combination products, particularly autoinjectors as well as pre-filled syringes and co-packed products. Expertise in design controls, device risk management, process development, process validation, automation and related scientific/technical concepts and techniques are a must for this position. The ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The Senior Engineer will routinely face competing priorities, and must manage time effectively, while keeping stakeholders and team members informed with effective communication. This individual will be expected to function as an independent contributor, supporting global and site-specific projects.

Primary responsibilities

• Facilitate technology transfer of medical devices and combination products from development to commercialization.

• Contribute to the design, construction, and validation of autoinjector assembly automation systems.

• Develop and implement risk management programs using device risk management tools for products throughout their lifecycle.

• Apply design control expertise throughout the product development lifecycle to deliver value-added solutions addressing customer needs.

• Lead and support technical investigations during the development, commercialization, and sustainment phases of the product lifecycle.

• Secure early sponsorship and alignment among stakeholders for key projects and initiatives.

• Demonstrate inclusive leadership by integrating diverse inputs, communicating decisions, and soliciting feedback to ensure customer and stakeholder needs are met.

• Work independently and collaboratively, embodying Integrity, Precision, Accomplishment, Motivational Ambition, Respect, and Inclusion.

Your profile

• Technical BS degree or higher required; preference for degrees in Mechanical, Chemical, Biomedical, or Materials Engineering.

• Minimum five years’ relevant experience in medical devices, combination products, pharmaceuticals, or biotech organizations.

• Proven expertise in assembly of autoinjectors, pre-filled syringe systems, or other complex device systems, including commercialization and operations support.

• Strong background in design transfer, technology transfer, process validation, scale-up, and design controls (ISO 13485), including design verification testing.

• Demonstrated proficiency in device risk management (ISO 14971:2019), including control strategies, FMEA/hazard analysis, and change control management.

• Experience in deviation management, Quality Management System documentation, regulatory inspection support, and Test Method Validation.

• Skilled in working with device suppliers, equipment manufacturers, and automation, including injection molding and design for manufacturing.

• Effective cross-functional project management and communication skills (English and Dutch), with experience collaborating internationally.

What we offer

Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end allowance.

• 35,5 days of leave.

• Attractive collective health care insurance package with considerable reduction rates.

• Solid Pension Plan.

• Annual bonus based on own and company performance.

• Travel allowance for commuting.

• 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:

Biomedical Engineering, Change Controls, Chemical Engineering, Combination Products, Commercialization, Communication, Design Controls, Equipment Automation, Equipment Qualification, Injection Moldings, Manufacturing Process Validation, Medical Device Assembly, Medical Devices, Technology Transfer

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/31/2026

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

Requisition ID: R373988