Boston Scientific Design Assurance Engineer III 

Malaysia, Penang 

490998510

Purpose Statement:

Develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Provides focused quality engineering support for sustaining and new product development to ensure the delivery of the highest quality product to the customer.

Job Responsibilities:

• Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices
• Applies judgement to solve problems and determines appropriate action by analyzing possible solutions and their impact on the business.
• Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Executes methodologies to effectively meet individual and team objectives.
• Keeps abreast of industry and standard practices.
• Supports departmental, functional, and divisional design quality goals and priorities.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Identifies and drives continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.
• Other duties as necessary or required by the organization.
• Partner with Design Ownership teams in Maple Grove, MN (USA), and Galway, Ireland.

Job Requirements:

• Candidate require process at least Bachelor’s degree in Chemical, Mechanical, Electrical or Biomedical Engineering, or equivalent.
• Minimum of 5 years of quality engineering experience in the medical device industry. Preferred design quality experience with knowledge of design control principles.
• Has knowledge of ISO 13485, ISO 14971, CFRs, and Quality System Regulations.
• Has knowledge of current and proposed US and EU regulations for medical devices.
• Familiar with ISO 13485 and MDSAP requirements.
• Ability to collaborate and work on a global team
• Ability to apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies)
• Ability to manage several projects simultaneously with keen attention to detail.
• Ability to review, collate, describe, and summarize scientific and technical data.
• Effective research and analytical skills.
• International travel & interface with EU and US design teams is required.