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Design Quality Engineer II at Boston Scientific Corporation Malaysia
Minnetonka, Minnesota, United States -
Full Time

Start Date

Immediate

Expiry Date

04 Feb, 26

Salary

0.0

Posted On

06 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Design Controls, Risk Management, Usability, Quality Assurance, Quality Engineering, Medical Device Development, Regulatory Requirements, ISO 14791, 21 CFR 820, ISO 13485, EU MDR, IEC 62366-1, Root Cause Analysis, Communication Skills, Complaint Data Review, Electronic Medical Equipment

Industry

Medical Equipment Manufacturing

Description
Your responsibilities will include: Develops understanding of Design Controls, Risk Management and Usability for Medical Devices. Supports departmental, functional, and divisional design quality goals and priorities. Executes methodologies to effectively meet individual and team objectives. Bachelor of Science in Mechanical / Biomedical Engineering or related discipline in the sciences. Minimum of 2+ years experience in Design Quality Assurance, related experience in quality engineering or NPD design within a regulated industry Experience with medical device development for single use devices Working knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820, 210, 211 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability). Understanding of Quality tools and methodologies with an emphasis on Design Controls, Root Cause Analysis and Risk Management. Strong communication skills (verbal & written) Ability to work independently and as part of a team. Ability to travel up to 10%. Comfortable with complaint data reviews and interpretation Experience with pharmaceutical or combination medical device development Experience with Electronic Medical Equipment.
Responsibilities
Develops understanding of Design Controls, Risk Management, and Usability for Medical Devices. Supports departmental, functional, and divisional design quality goals and priorities.