Skip to main content

Careers

Job Position

Clinical Manager/director, Regulatory Assurance/quality Assurance

Position Summary

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.

Qualifications

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).

Responsibilities

  1. Reporting to the President & COO and working with other members of ABS’s senior management team (Research & Development, Operations, Finance & Clinical), lead ABS’s RA/QA functions.
  2. Responsible for the development & execution of ABS’s Clinical Plan.
  3. Recruit, train and manage a team of operations engineers, technicians and associates within the parameters of the RA/QA Plan.
  4. Responsible for managing ABS’s relationship with clinical sites. clinical vendors, consultants, regulators and strategic partners as relevant to the Clinical Affairs functions.
  5. Other duties and responsibilities as mutually agreed.

Attributes

  1. Innovative, Creative, Team Player
  2. Strong leadership skills.
  3. Strong written and verbal communication skills
  4. Ability to work in a rapidly changing and evolving environment

Compensation

Salary Range: $160,000 – $220,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation

Manager, Drug Development

Position Summary

Reporting to the President & COO, the Manager, Drug Developmen has leadership responsibility for all of ABS’s drug eluting stent research & development efforts

Qualifications

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).

Responsibilities

  1. Reporting to the President & COO and working with other members of ABS’s senior management team (Operations, Finance, Clinical & RA/QA), lead ABS’s drug eluting stent development efforts.
  2. Responsible for the development & execution of ABS’s Drug Development Program.
  3. Train and manage a team of R&D engineers and technicians within the parameters of the Drug Development Program.
  4. Assist in the continuous development of ABS’s intellectual property portfolio.
  5. Work cooperatively and effectively with internal team members and external partners, vendors and consultants.
  6. Other duties and responsibilities as mutually agreed.

Attributes

  1. Innovative, Creative, Team Player
  2. Strong leadership skills.
  3. Strong written and verbal communication skills
  4. Ability to work in a rapidly changing and evolving environment

Compensation

Salary Range: $160,000 – $200,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation

Senior Engineer, Drug Development

Position Summary

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.

Qualifications

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.

Responsibilities

  1. Reporting to the President/COO and to the Manager, Drug Development, have functional responsibility for product development within the scope of ABS’s Drug Development Program.
  2. Responsible for ensuring that ABS’s product development activities: (i) meets all quality system requirements; (ii) meets or exceeds manufacturing protocols and processes typical for medical device companies similar to ABS; (iii) is efficient with respect to the utilization of ABS resources and ABS’s Drug Development Program; and (iv) work effectively with internal team members and external partners.
  3. Other duties and responsibilities as mutually agreed.

Attributes

  1. Innovative, Creative, Team Player
  2. Strong leadership skills.
  3. Strong written and verbal communication skills
  4. Ability to work in a rapidly changing and evolving environment

Compensation

Salary Range: $140,000 – $170,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation

Document Control Specialist

Position Summary

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”).

Qualifications

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.

Responsibilities

  1. Reporting to the Director, Quality Control & Assurance and working with fellow team members, developing, managing and maintaining documentation control system in compliance with ABS’s QMS.
  2. Responsible for ensuring that ABS’s documentation and documentation control system (i) meets all quality systems regulatory requirements; (ii) meets or exceeds documentation control system standards typical for medical device companies similar to ABS; (iii) is efficient with respect to the utilization of ABS resources and ABS’s QMS; and (iv) work cooperatively and effectively with internal team members and external partner
  3. Other duties and responsibilities as mutually agreed.

Attributes

  1. Innovative, Creative, Team Player
  2. Strong written and verbal communication skills
  3. Ability to work in a rapidly changing and evolving environment

Compensation

Salary Range: $70,000 – $120,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation

Engineering Technician

Position Summary

Reporting to a Senior Engineer, the Technician will have responsibility for key aspects of ABS’s research & development and product manufacturing processes.

Qualifications

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.

Responsibilities

  1. Reporting to a Senior Engineer, the Technician will have responsibility for key aspects of ABS’s research & development and product manufacturing processes.
  2. Assist in assuring that product output: (i) meets or exceeds all quality system requirements; (ii) meets productivity standards; and (iii) is efficient with respect to the utilization of ABS resources.
  3. Other duties and responsibilities as mutually agreed.

Attributes

  1. Innovative, Creative, Team Player
  2. Strong written and verbal communication skills
  3. Ability to work in a rapidly changing and evolving environment

Compensation

Salary Range: $40,000 – $80,000, Bonus, Benefits (fully paid health, dental, vision plan) & Equity Participation

ABS® makes the impossible possible

Simplifying bifurcation operations with short and precise stent delivery

Be a ABS® investor

This is your opportunity to be part of an aggressive, global marketing strategy that will promote rapid penetration and sales. To join, simply fill out the form and one of our staff will get in touch with you.