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 youll collaborate closely with diverse stakeholdersincluding Manufacturing External Partners R&D Quality Assurance Operations Product Development Regulatory Affairs Procurement and key suppliersto 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 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.

• 355 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

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