Design Assurance Engineer, Senior (Electrophysiology (EP)) at Boston Scientific Corporation Malaysia

La Asunción, Cantón de Belén, Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

19 Feb, 26

Salary

0.0

Posted On

21 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Assurance, Electrophysiology, Risk Management, Quality Assurance, Design Controls, Problem Solving, Statistical Techniques, Regulatory Compliance, Cross-Functional Collaboration, Product Development, Communication Skills, Self-Motivation, Project Management, Manufacturing Input, Design Validation, Verification Activities

Industry

Medical Equipment Manufacturing

Description

Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success. Able to understand device performance and anatomy interaction and identify opportunities for device and procedure improvements. Leads the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input. Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs). Leads the development of and coordinates the execution and documentation of Design Validation and Verification activities. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc. Expertise in the validation and statistical techniques to comply with associated regulatory requirements and internal standards. Able to navigate gray space by applying risk-based criteria to prioritize project work. Leads cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables. Ability to work with minimal supervision and self-learning skills. Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study. English Level desired: 80-89%. Minimum 5 years of experience in Quality Assurance and/or Design Assurance, New Product Development or related medical device experience. ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis. Self-motivated with a passion for solving problems and a bias for action. Ability to manage multiple priorities and work with ambiguity. Hands-on approach to product development. Strong communication skills (verbal & written). Proficiency in collaborating with interdisciplinary teams.

Responsibilities

The Design Assurance Engineer will work cross-functionally with various teams to ensure project success and lead the implementation of design controls based on risk management and customer needs. They will also maintain product risk management documentation and lead design validation and verification activities.