Senior Design Assurance Engineer at Boston Scientific Corporation Malaysia

Minnetonka, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Problem Solving, Design Assurance, Risk Management, Quality System Integration, Verification, Validation, Usability Testing, Technical Documentation, Medical Electrical Equipment, ISO 13485, ISO 14971, Quality System Regulations, Design Controls, Risk Analysis, Complaint Reduction, Corrective Action

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: 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 integration of design control related products, records, and processes Support Design Assurance activities as related to Risk Management remediation, Design Control Quality System integration, and other DA related integration priorities Support Post Market activities, as necessary, of risk based on post-market signals Support the verification, validation, and usability testing to meet or exceed internal and external requirements Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints) Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline) 5+ years of experience in design assurance, new product development or related medical device / regulated industry experience Self-motivated with a passion for solving problems and a bias for action Strong communication skills (verbal & written) Demonstrated use of Quality tools/methodologies Ability to effectively work and collaborate in a mixed onsite + remote environment Demonstrated experience creating detailed technical documents Experience working with medical electrical equipment and/or active implantables Quality Integration experience ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis Experienced problem solver, capable of facilitating the problem-solving process Adaptable and effective collaborator in a team environment or in self-directed work Experience with design changes, complaint reduction, and corrective action

Responsibilities

The Senior Design Assurance Engineer will apply systematic problem-solving methodologies to resolve quality issues and support design assurance activities related to risk management and design control integration. They will also be responsible for maintaining design history files and documentation.