Design Assurance Engineer II

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

For more than 35 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.

There's never been a better time to be a part of Boston Scientific and our team. This is an exciting moment: when our legacy of industry leadership intersects with the promise of a brilliant future. Today, we're at the forefront of the medical device industry – leading, evolving and transforming it into bolder and more amazing territories, with an impressive portfolio.

We have an excellent opportunity for an experienced Design Assurance Engineer II to join our team.

Job Purpose

Fulfil the quality assurance responsibilities of BSC’s new product development and post market (commercial product) support, including:

• Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality in BSC.

• Understanding and complying to BSC’s quality, business, health & safety systems and market/legal regulations governing the quality systems.

• Removing or mitigating against risks associated with the design, use and manufacture of BSC devices.

• Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.

  
  

Key Responsibilities

General

• Completes work assignments under limited supervision/guidance.

• Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.

• Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.

• Identifies and resolves complex exceptions to work assignments.

• Seeks to support improvements in product and process quality.

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

• Excellent interpersonal and communication skills with good leadership abilities.

Technical

• Provides both quality and technical input to ongoing product development and post market commercial product activities.

• Experienced in post market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).

• Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.

• Excellent analytical and problem-solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.

Leadership

• Is an active team member completing quality deliverables associated with BSC’s new product development and post market (commercial product) support.

• Coach others in areas of expertise. Gives technical guidance to junior team members. Uses opportunities in project assignments to develop self & others.

• Is a fully motivated team member - achieves and demonstrates best practices in line with set objectives.

• Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.

  
  

Qualifications & Experience

• HETAC Level 8 (240 credits) in a STEM discipline with a minimum of 3-4 years’ experience in a similar role.

• Good technical capabilities, communication skills, teamwork abilities and initiative.

• Proven ability to work well as part of a team & on own with minimum supervision.

  
  

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. If you require any arrangements during the recruitment process, please let us know.

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