Design Assurance Quality Engineer III at Boston Scientific Corporation Malaysia

, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

26 Feb, 26

Salary

0.0

Posted On

28 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Quality Assurance, Risk Management, Problem Solving, Communication, Collaboration, Medical Device Engineering, Regulatory Compliance, Usability Testing, Design Controls, Statistical Analysis, Cross Functional Teamwork, Design Change Analysis, Quality Assurance, FDA Regulations, ISO Standards, Medical Device Software

Industry

Medical Equipment Manufacturing

Description

Contributing to all aspects of Design Quality Assurance activities in an FDA/EU MDR regulated environment. Working within a cross functional team of Sustaining Engineers and Specialists such as: R&D, Regulatory Affairs, Marketing, Medical Safety, Manufacturing, Quality, Production and others. Provide quality and compliance input to project teams for project decisions and deliverables (i.e Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing and Labeling). Participate in product, system, and sub-system level design changes with focus on device design evaluation, design controls, product risk mitigation, and other risk management activities. Champion compliance to company policies, work instructions and SOPs. Support the creation, review and maintaining of risk management documentation such as: Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA), Fault Tree Analysis (FTA) and Usability Engineering documentation. Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e 5 Whys Analysis, Is-Is Not Analysis, Cause and Effect Analysis and DMAIC problem solving methodologies). Participating in Value Improvement Projects (VIPs), cost reduction initiatives such as: new suppliers, alternate materials, design changes, etc. Support DQA activities during internal and external audits, as needed. May perform other duties as directed BS in Biomedical, Mechanical Engineering, or related technical discipline. Minimum of 3 years of medical device or related engineering experience. Working knowledge of the FDA, ISO, EUMDR and medical device industry quality requirements associated with product development, design controls, product risk management, usability engineering and medical device software. Strong communication and presentation skills. Strong problem solving and critical thinking skills. Competent with use of Microsoft Office Suite and Minitab statistical analysis software (or equivalent). Ability to collaborate and work in a global team. Position located in Coyol, Costa Rica. Willing / able to travel approximately

Responsibilities

Contribute to Design Quality Assurance activities in a regulated environment and provide quality input to project teams. Participate in design changes with a focus on risk mitigation and compliance with company policies.