Senior Engineer MDCP
Senior Engineer MDCP
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Job Description
Job Description
Join Us in Haarlem as a Senior Engineer MDCP Packaging Technical Operations
Are you passionate about bringing new products to life ensuring seamless technical execution and supply to our patients Were looking for a driven and collaborative Senior Engineer MDCP to join our Packaging Technical Operations team in this role youll 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. Youll thrive in a fast-paced environment managing priorities effectively while communicating clearly with stakeholders to deliver robust technical solutions.
This individual is expected to function as an independent contributor while supporting global or site-specific projects. The role includes leading enabling or consulting in the development and execution of technical and risk management documentation associated with MDCP new product introductions assessing changes to device assembly and packaging processes problem-solving and continuous improvement working with internal and external partners. This role will work closely with the Haarlem site QA and Operations MDCP Leads Device Development and Technology PTO Engineers and our Product Development and Commercialization groups among others.
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
We welcome you to a truly global dynamic and challenging environment with great opportunities for personal development. 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 bonus;
355 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:
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Applied Engineering Biomedical Engineering Capital Project Management Change Management Combination Products Data Analysis Design Controls Deviation Management Equipment Qualification Facility Management Good Manufacturing Practices (GMP) Injection Moldings Maintenance Supervision Management Process Mechanical Engineering Medical Device Management Medical Devices Occupational Safety and Health Packaging Packaging Processes Project Management Regulatory Audits Regulatory Compliance 5 morePreferred Skills:
Job Posting End Date:
10/31/2025*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.
Required Experience:
Senior IC
Employment Type
Full-Time
