About this role
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 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) Support Design Assurance (DA) activities as related to Design Control Quality System integration, and other DA related integration priorities Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline) Minimum of 2 years of experience in Quality design assurance, new product development or related medical device/regulated industry experience Ability to travel up to 10% Quality Integration experience ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis Ability to effectively work and collaborate in a mixed onsite + remote environment.
Other facts
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.
For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook.
At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers.
You may also review our social media guidelines at http://www.bostonscientific.com/social.
What you'll do
- The Design Quality Engineer II will apply systematic problem-solving methodologies to resolve quality issues and support the integration of design control related products and processes. They will also support verification, validation, and usability testing to meet internal and external requirements.
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