Boston Scientific
Design Quality Engineer II
Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing
whatever your ambitions. About the role: Boston Scientific is currently recruiting for a Design Quality Engineer II in our Maple Grove, MN location. This is an exciting opportunity to participate in the quality assurance of single use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC. The Design Quality Engineer II will support the application of design controls to focusing on new product development and sustaining engineering projects. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products. Your responsibilities will include: Works within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements Update and maintain risk management files, such as Hazard Analysis, Task Analysis, and Design FMEA. Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. Apply judgement to solve problems and determine appropriate action and solutions Supports departmental, functional, and divisional design quality goals and priorities. Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. Builds quality into all aspects of work by maintaining compliance to all quality requirements What we're looking for in you: Required qualifications: Bachelor's degree in an engineering discipline Minimum 2 years of experience in design assurance, quality, or related medical device or regulated industry experience Knowledge of basic Quality System Requirements and Good Documentation Practices Experience writing specifications, test protocols, and technical reports Strong communication skills (verbal and written). Effectively organize, present, and explain information to internal audiences. Preferred qualifications: Bachelor's degree in mechanical, electrical, chemical, or biomedical engineering Demonstrated use of quality tools and methodologies including DFMEA, Hazard Analysis, Root Cause Analysis, CAPA Demonstrated ability to solve engineering problems using analysis, experimentation, and statistics Experience with medical device standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization. Adaptable and effective collaborator in a team environment and in self-directed work The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most
united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do
as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing
whatever your ambitions. About the role: Boston Scientific is currently recruiting for a Design Quality Engineer II in our Maple Grove, MN location. This is an exciting opportunity to participate in the quality assurance of single use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC. The Design Quality Engineer II will support the application of design controls to focusing on new product development and sustaining engineering projects. This individual will work with a high performance cross-functional team to ensure safety, quality, and compliance of products. Your responsibilities will include: Works within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements Update and maintain risk management files, such as Hazard Analysis, Task Analysis, and Design FMEA. Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements. Apply judgement to solve problems and determine appropriate action and solutions Supports departmental, functional, and divisional design quality goals and priorities. Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs. Builds quality into all aspects of work by maintaining compliance to all quality requirements What we're looking for in you: Required qualifications: Bachelor's degree in an engineering discipline Minimum 2 years of experience in design assurance, quality, or related medical device or regulated industry experience Knowledge of basic Quality System Requirements and Good Documentation Practices Experience writing specifications, test protocols, and technical reports Strong communication skills (verbal and written). Effectively organize, present, and explain information to internal audiences. Preferred qualifications: Bachelor's degree in mechanical, electrical, chemical, or biomedical engineering Demonstrated use of quality tools and methodologies including DFMEA, Hazard Analysis, Root Cause Analysis, CAPA Demonstrated ability to solve engineering problems using analysis, experimentation, and statistics Experience with medical device standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization. Adaptable and effective collaborator in a team environment and in self-directed work The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most
united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do
as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.