Senior Specialist, Drug/Device Combination Products (Remote)
About the position 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.