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Senior Design Assurance Engineer Job

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Date: Nov 24, 2021

Location: Galway, Ireland

Company: Boston Scientific

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 continued expansion of our operations, we are seeking applications from a suitably qualified and experienced Senior Design Assurance Engineer (Permanent).

 

Job Purpose

Senior Design Assurance position required to support increased scope of compliance and associated changes within EU MDR. Activities will relate to monitoring Product Performance and completing Post Market Surveillance reviews for commercially released Drug Eluting Stent and Cutting Balloon products.

Design Assurance engineers are responsible for ensuring quality assurance activities are meet by creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality in BSC.

  • Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.

  • Promoting and effecting compliance to BSC’s quality, business and health & safety systems and market/legal regulations.

  • Analysing, reducing and managing risks associated with the design, use and manufacture of BSC devices.

  • Providing expertise in BSC’s product development systems to project teams

  • Supervising, leading and coaching members of the design assurance department

 

Key Responsibilities

General

  • Interfaces with Post Market Teams (CIS, CMC and Trending) R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.

  • Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance to internal and external post market surveillance requirements.

  • Monitor the release and updates of quality policies to ensure compliance with Post Market Surveillance needs, including any interferences with Design Control and Risk Management.

  • Continually seeks to drive improvements in product and process quality.

  • Implement, maintain and update procedures that ensure that design documentation constantly meets BSC’s Post Market Surveillance, Product Development and Design Control requirements.

  • Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product line with respect to product performance

Technical

  • Provides regulatory compliance, risk management, design control and quality systems expertise to the team.

  • Identifies and resolves complex exceptions to work assignments.

  • Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.

  • Fully conversant with Post Market Surveillance, Risk Management, and associated regulatory requirements

  • Build Quality into all aspects of work by maintaining compliance to all quality requirements.

  • Keeps up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group.

 Leadership

  • Is an active member of the project team, formulating strategy and leading execution on quality deliverables as outlined in BSC’s Product Development Process (PDP), Recertification, Post Market Surveillance, Risk Management and Design Control SOPs.

  • Co-ordination of team activities in line with departmental objectives and project goals.

  • Supervision and development of staff reporting to them in line with departmental and project goals.

  • Uses opportunities in project assignments to develop other team members.

  • Coaches others in analysis and decision making. A source of technical guidance to Quality Engineer II, Quality Engineer I, Graduate Quality Engineer, Technician and Inspection staff.

  • Is perceived as a proponent of change within the project/department and willing to challenge the status quo to create best in class.

  • Is a good team member, committed to the projects success and fully motivated to achieve and demonstrate best practices in line with the department and site objectives.

  • Provide guidance on Post Market Surveillance and Product Performance requirements to PDP/TDP teams and sustaining engineering activities in line with BSC policies and procedures

 

Qualifications

  • Graduate of Engineering, Sciences (or associated branch of learning) - level 8
  • At least 5 years experience in a similar role
  • Experience in Medical Device or Pharmaceutical environment at Engineering level (design development, post market, or quality).

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important 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.At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important 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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