Design Assurance Engineer II at Boston Scientific Corporation Malaysia

Heredia, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

02 Jan, 26

Salary

0.0

Posted On

04 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Problem Solving, Critical Thinking, Statistical Tools, Collaboration, Multi-tasking, Adaptability, Presentation Skills, Facilitation Skills, Quality System Regulations, Medical Device Regulation, Quality Standards, Risk Management, Leadership Skills

Industry

Medical Equipment Manufacturing

Description

Collaborate and lead to solve complex engineering problems using analysis, experimentation, and statistics. Apply sound, systematic problem-solving methodologies in prioritizing, communicating, and helping resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies). Intermediate conceptual knowledge of Design Controls. Assist 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, Process Validation and Labeling). Create, maintain and/or support safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Task and Use Error Analysis, Risk Management Plan, Risk Management Report, and DFMEA. Collaborate with quality trending using the complaint and NCEP/CAPA systems. Assist, communicate, and coordinate complaint reduction and post market projects and initiatives and roll-out with cross-functional teams. Communicate product performance by formal presentations to management, cross-functional team members, committees and/or design teams, supporting published product performance reports. Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. Understand and support linkage of field data and Risk Management. Support and lead project decisions on quality and compliance inputs for post market product sustaining activities, such as design changes, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP's, CAPA's PIRs, Field Signals Evaluations and Field Actions. Contribute with internal and external regulatory audits, as required. Cooperate and contribute to developing test method validation protocols and reports, and design verification activities. Work with cross functional teams to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components. Bachelor or Licentiate near-graduates in Chemical, Mechanical, Mechatronics, Materials, Biomedical Engineering or related. English Level desired: 85-95%. Experience: 2+ years Desired knowledge: Problem Solving, critical thinking, statistical tools. Ability to collaborate across multiple and cross-functional teams. Strong ability to multi-task and be adaptable. Strong presentation and facilitation skills. Experience with and/or knowledgeable in Quality System Regulations, Medical Device Regulation, and Quality Standards. Demonstrated understanding of risk management. Leadership skills.

Responsibilities

The Design Assurance Engineer II will collaborate and lead efforts to solve complex engineering problems while applying systematic problem-solving methodologies. They will assist project teams with various design and quality assurance tasks, including risk management and compliance activities.