Senior Specialist, Drug/Device Combination Products (Remote)

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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.
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