Senior Specialist, Drug/Device Combination Products (Remote)

About the position The Senior Engineer in Device Technology is a key member of our Device Development & Technology Team, with responsibilities supporting the commercialization and sustainment of medical devices and combination products globally. Experience in design controls, device risk management, medical device, complex combination product kits, prefilled syringes, autoinjectors, 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, including those related to Combination Products and Drug Delivery Systems. The role includes leading, enabling or consulting in the development and execution of related strategic plans for problem-solving and continuous improvement by working with internal and external partners. The key stakeholders include our Company Manufacturing sites, External Manufacturing, R&D, Quality, Operations, Product Development groups, Regulatory Affairs, Procurement, and suppliers.

Responsibilities

• Complete all activities with the highest regard for all of our Company divisional and local site procedures for safety, quality, and regulatory compliance.
• Understand the big picture, and how activities link to our Company strategy and business goals.
• Utilize device risk management tools to build device combination product risk management programs in development and life cycle management.
• Utilize design control experience to develop value-add solutions to customer needs in medical devices and combination products.
• Secure early sponsorship and stakeholder alignment for projects and initiatives.
• Operate effectively as a leader in assigned roles.
• Demonstrate the necessary Inclusion skills to integrate inputs and perspectives from various sources, and communicate the decision to key stakeholders and sponsors.
• Solicit feedback to ensure that customer/stakeholder needs are the cornerstone of decisions and expectations.
• 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.

Requirements

• Bachelor of Science 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, risk management/ISO 14971-2019 and the fundamentals of documentation structure/systems.
• Experience with medical device combination product commercialization, tech transfers, operations support, and materials components.
• Proficiency in project management.
• Principled verbal and written communications.
• Five plus years in medical device, pharmaceutical or in biotech organizations.
• Five plus years in design control, risk analysis and change control management for medical device combination products.
• Demonstrated technical leadership to medical device and combination product manufacturing sites and functional areas, including the preparation of official documents.
• Experience with autoinjectors or other complex drug-delivery systems and associated prefilled syringe components.
• Experience with design verification testing.
• Experience in working with medical device suppliers.
• Experience with injection molding, device assembly, and/or design for manufacturing.
• Experience in commercialization of high-volume medical device combination products.

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