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Design Assurance Manager II

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Galway, G, IE

More than the opportunity of a lifetime......the opportunity to improve lives

For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine. The Company's products help physicians and other medical professionals improve their patients' quality of life by providing alternatives to surgery. Since 1994, employees in Galway have been at the forefront of some of these truly innovative medical device designs and manufacturing.

 

Due to the continued expansion of our operations, we are seeking applications from a suitably qualified and experienced Design Assurance Manager II.

 

As our new Design Quality Assurance Manager, you will join our rapidly growing Interventional Cardiology - Coronary Therapies Franchise. You will provide design assurance leadership and strategic direction in this role by partnering with our global Coronary Therapies Valve R&D, Regulatory, Quality, Post Market, and Marketing teams.

 

This will be an exciting journey! We seek a dynamic individual looking for a unique opportunity to lead design assurance strategy and execution through the full development life cycle. If this strategic and critical role excites you, we would love to talk about having you join our team.

 

Responsibilities include:

  • Lead the Design Assurance for New Product Introduction, Sustaining Engineering for commercialized products, and Post Market Surveillance activities
  • Be the SME and lead in the areas of QSR and ISO/MDD standards, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Design Assurance Director as the final arbitrator on critical quality decisions.
  • Ensure effective implementation of Risk Management deliverables to achieve compliance with ISO 14971 and demonstrate a primary commitment to patient safety.
  • Lead project teams and franchises in the execution of Quality Deliverables, including but not limited to Post-Market Surveillance Plan & Report, Field Assessment Plan and Clinical Evaluation Reports
  • Make decisions related to product quality, including the disposition of the non-conforming products.
  • Develop and manage a high-performance design quality assurance team focusing on customer needs, compliance, product quality, and risk mitigation.
  • Drive continuous improvement by championing and fostering the execution of projects within the local and Global Design Assurance and Post Market organizations to drive the process and product performance.
  • Participate with and present to appropriate Corporate Quality teams.
  • Develop, direct, and ensure appropriate execution of design planning, verification, validation, and useability requirements for newly designed or modified products and processes.
  • Take a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on-site and across the Corporation where possible.
  • Develop staff on new quality initiatives and assist in understanding and rolling out quality initiatives across the department/site.
  • To establish and support a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for the area.
  • Ensure employees are trained to do their work, and their training is documented.

 

What we're looking for:

  • Bachelor's Degree in Mechanical Engineering, Materials Science, Biomedical Engineering or other relevant technical disciplines.
  • 8-10 years of related work experience.
  • Proven technical leadership and project management skills in medical device design, development and commercial launch. 
  • Proven experience in a leadership position as an Independent critical thinker, strong communicator, and networker.
  • Ability to interface with customers to gather insight and get organizational buy-in on key design inputs.
  • Knowledge/Experience of Design Controls and FDA/ISO Medical Device Regulations.
  • Understanding of risk management and design controls tools and requirements for medical device product development.
  • An influential team member, fully motivated to achieve and demonstrate best practices in line with the department and long-range planning objectives.
  • Familiar with the internal auditing process.

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative, and it is essential in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

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