MSD Senior Medical Device Combination Product Engineer - Hybrid 

Ireland 

24084281

and inclusive work environment

As a key member of our Device Development and Technology Organization, you willbe responsible forsupporting the development, commercialization, and sustainment of medical devices and combination products globally. This role requiresin design controls, device risk management, medical devices, combination products, prefilled syringes, autoinjectors, process validation, and device assemblyand packaging

You will work in a fast-paced operating environment, resolving issues and meeting customer needs in a compliant manner. Effective time management and communication skills are essential as you willface competing priorities and engage with stakeholders

As an independent contributor, you will support global and site-specific projects related to Combination Products and Drug Delivery Systems. This includes leading, enabling, or consulting on strategic plans fordesign & technology transfer,problem-solving and continuous improvement, working closely with internal and external partners. Key stakeholders include Manufacturing sites, External Manufacturing, R&D, Quality, Operations, Product Development groups, Regulatory Affairs, Procurement, and suppliers.

Key Responsibilities:

• demonstratingintegrity, precision, accomplishment, motivational ambition, respect, and inclusion.

• Complete all activities with the highest regard for safety, quality, and regulatory compliance.

• Understand the big picture and how activities link to our company's strategy and business goals.

• Utilize device risk management tools to build device or combination product risk management programs.

• Apply design control experience to develop value-added solutions for medical devices and combination products.

• Secure early sponsorship and stakeholder alignment for projects and initiatives.

• Display leadership skills and inclusive decision-making when integrating inputs and perspectives from various sources.

• Solicit feedback to ensure customer/stakeholder needs are central to decisions and expectations.

• Lead technical investigations of medicaldeviceand combination product needs for commercial products.

• Facilitate technology transfer from development to commercialization for medicaldeviceand combination products.

Requirements:

• Technical BS degree or higher, preferably in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or a similar field.

• Minimum five years of relevant experience in medical devices or combination products.

• Experience in medical deviceand/or combination product commercialization, operations support, andmaterials/components.

• Experience with autoinjectors, complex drug-delivery systems, and associated pre-filled syringe systems or cartridges.

• Demonstrated technical leadership in medical device and combination product manufacturing assembly and packaging sites and functional areas.

• Experience working with medical device suppliers and equipment manufacturers.

• Experience in deviation management, change control,design for manufacturing,process scale-up,andprocessvalidation

There is a requirement to travel 20/25% across Europe.

hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,