Job Description

There's never been a better time to be a part of Boston Scientific. This is an exciting moment: when our legacy of industry leadership intersects with the promise of a brilliant future. Today, we're 23,000 colleagues strong, with an impressive portfolio of 13,000 products. We’re at the forefront of the medical device industry – leading, evolving and transforming it into bolder and more amazing territories.

We have an excellent opportunity for an experienced Design Assurance Engineer to join our team on a defined-term basis.

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.
  • Coaches 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 s
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