Reporting to the President & COO, the Clinical Manager/Director, Regulatory Assurance/Quality Assurance (“Clinical Manager/Director, RA/QA”) has management responsibility for all of ABS’s Clinical activities.
BS, MSc, PhD, PEng or equivalent education preferred and relevant professional experience required, including functional leadership experience, in the medical devices sector. The incumbent should have extensive experience (10+ years) in leading regulatory and clinical programs focused on the development and commercialization of medical devices (ideally in the cardiology field).
Salary Range: $160,000 - $220,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation
Reporting to the President & COO, the Manager, Drug Developmen has leadership responsibility for all of ABS’s drug eluting stent research & development efforts
MSc., PhD, PEng, or equivalent education and professional experience, including functional leadership experience, in the medical devices sector. The incumbent should have extensive functional experience (10+ years) in leading research & development and manufacturing teams focused on combination device development (ideally in the cardiology field).
Salary Range: $160,000 - $200,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation
Reporting to the President/COO and to the Manager, Drug Development, the Senior Engineer, Drug Development will have responsibility for design, development and product manufacturing within the scope of ABS’s Drug Development Program.
BS, MSc, MEng, PhD, PEng, or equivalent education and professional experience, including research & development, functional experience in manufacturing operations in the medical devices sector (ideally in the cardiology field). Minimum experience: 7 years preferred.
Salary Range: $140,000 - $170,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation
Reporting to the Director, Quality Control & Assurance, the Document Control Specialist, working with the QA Engineer, will have responsibility for developing, managing and maintaining ABS’s documentation control system in compliance with ABS’s Quality Management System (“QMS”).
BSc, BA, AA, or equivalent education preferred and relevant professional experience, including operational experience in developing and managing document control systems, and in the preparation of FDA and CE Mark filings, in the medical devices sector (ideally in the cardiology field). Experience: ideally 5 + years required.
Salary Range: $70,000 - $120,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation
Reporting to a Senior Engineer, the Technician will have responsibility for key aspects of ABS’s research & development and product manufacturing processes.
Undergraduate degree or equivalent education preferred and relevant professional experience, including functional operational experience in the medical devices sector as well as previous FDA and CE submission experience is a plus (ideally in the cardiology field). Experience: 5+ years.
Salary Range: $40,000 - $80,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation