Senior Specialist, Drug and Device Combination Products (Remote)

Merck & Co. - West Point, PA

Full-time - Mid Level

Onsite - West Point, PA

Chemical Manufacturing

About the position

The Senior Engineer in Device Technology plays a crucial role in the Device Development and Technology Organization, focusing on the commercialization and sustainment of medical devices and combination products globally. This position requires expertise in compliance documentation, design controls, and risk management, with a strong emphasis on meeting customer needs in a fast-paced environment. The Senior Engineer will work independently and collaboratively with various stakeholders to drive strategic plans for problem-solving and continuous improvement.

Responsibilities

• Support the commercialization and sustainment of medical devices and combination products globally.
• Author ISO-13485 and 21 CFR 820 compliance technical documents.
• Manage design controls and device risk management processes.
• Lead technical investigations of medical device and combination product needs for commercial products.
• Facilitate technology transfer of medical device and combination products from development to commercialization.
• Secure early sponsorship and stakeholder alignment for projects and initiatives.
• Utilize device risk management tools to build risk management programs in development and life cycle management.
• Demonstrate inclusion skills to integrate inputs and perspectives from various sources.

Requirements

• Technical BS degree or higher in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar.
• Five years of relevant experience in medical devices or combination products.
• Experience in design controls, ISO 13485, deviation management, change control, and risk management/ISO 14971-2019.
• Proficiency in GMP documentation, technical writing, and project management.
• Demonstrated technical leadership in medical device and combination product manufacturing.

Nice-to-haves

• Five plus years in medical device, pharmaceutical, or biotech organizations.
• Experience with pre-filled syringe design, process, and development.
• Experience in working with medical device suppliers.
• Experience in design history file management.

Benefits

• Inclusive and diverse workplace environment.
• Commitment to employee development and continuous improvement.