Principal Design Quality Engineer at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

0.0

Posted On

07 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Control, Risk Management, Problem Solving, Validation Techniques, Statistical Techniques, Quality Assurance, Communication Skills, Organizational Skills, Planning Skills, Team Leadership, Medical Devices, ISO Standards, Regulatory Compliance, FMEAs, Hazard Analysis, Fault Tree Analysis

Industry

Medical Equipment Manufacturing

Description

Responsible for design control and risk management of next-generation medical devices Uses clinical knowledge to influence how devices are tested and designed Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs) Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team Promotes and influences compliance to BSC's quality, business and health & safety systems and market/legal regulations Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines). Keeps up to date on all ISO/EN/FDA/MDR and other Product Development-related regulatory requirements and relays this information to the Product Development group Bachelor's degree in engineering or science discipline, or equivalent. Minimum of 8 years experience in design assurance, quality, or related medical device or regulated industry experience ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use Strong communication skills (verbal & written) and presentation skills Problem solver, capable of facilitating the problem-solving process & driving issues to closure Excellent organizational and planning skills; drives for results Travel approximately up to 20% Focus on detailed work with emphasis on accuracy and completeness Ability to collaborate and work on a highly matrixed and global team Experience mentoring and leading a team Experience with Class II & III Medical Devices

Responsibilities

The Principal Design Quality Engineer is responsible for design control and risk management of next-generation medical devices. This role involves leading the implementation of product risk management tools and ensuring compliance with regulatory requirements.