Senior Design Quality Engineer at Boston Scientific Corporation Malaysia

La Asunción, Cantón de Belén, Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

24 Feb, 26

Salary

0.0

Posted On

26 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Validation, Verification, Usability Testing, Problem Solving, Cross-Functional Collaboration, Risk Management, Design Controls, Quality Compliance, Root-Cause Analysis, CAPA, FMEA, Regulatory Submissions, Communication Skills, Quality Methodologies, Medical Device Regulations, Technical Specifications

Industry

Medical Equipment Manufacturing

Description

Support the execution and documentation of Design Validation & Verification and Usability activities. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization. Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs). Working knowledge of Design Controls. 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, Process Validation and Labeling). Lead and support cross-functional root-cause analysis investigation and resolution activities. Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc. Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes. Support regulatory submissions to notified bodies. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedure. Bachelor's degree in mechanical engineering, Biomedical Engineering or related field of study 5+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971. High energy problem solver capable of driving items to closure. Adaptable and effective collaborator in a team environment and in self-directed work Strong communication skills (verbal & written) Demonstrated use of Quality tools/methodologies

Responsibilities

Support the execution and documentation of Design Validation & Verification and Usability activities while working within a cross-functional team. Lead and support root-cause analysis investigations and ensure compliance with quality processes.