Boston Scientific
Associate Design Assurance Director
Boston Scientific, Osseo, Minnesota, United States, 55311
Additional Location(s):
US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove
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:
The Associate Design Assurance Director will ensure that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system. The Design Assurance (DA) Associate Director will work with the existing DA teams to: Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product. Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Exceed customer expectations by responding to field events in a professional and timely manner. Minimize the number of field events by building in quality into the design, through effective analysis of returned products, corrective actions and timely investigation and response to field events and post market monitoring through post market surveillance activities.
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities will include: Recruits, coaches and develops organizational talent. Manages both NPD, Sustaining and VIP activities with existing DA teams. Represent QA in internal and external audits as a facilitator and SME. Works closely with PMO to ensure the division is properly resourced to support projects Drives PIRs, may own or contribute to the PIR process/document. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Creates an entrepreneurial environment. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees. Keeps the organization's vision and values at the forefront of decision making and action. Demonstrates effective change leadership. Builds strategic partnerships to further departmental and organizational objectives. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Monitors compliance with company policies and procedures (e.g. compliance with FDA, TUV, EUMDR regulations, etc.). Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives. Required qualifications:
Bachelor's degree (Engineering) Minimum of 7 years of Design Assurance Minimum of 5 years of supporting product development Minimum of 8 years of leadership experience Minimum of 10 years' experience in medical devices Solid understanding of US and OUS regulations and requirements for product development Preferred qualifications:
Master's degree (Engineering) 10 years of DA experience 15 years in Product Development (medical devices) 10 years of leadership experience Prior experience in Process Development, PMO, Reliability, Complaints handling Experience with complex capital equipment Experience with product that include Software or embedded firmware Experience with active implantable devices
Requisition ID: 601142
Minimum Salary: $ 140000
Maximum Salary: $ 266000
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--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.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for
non-exempt (hourly), non-sales roles
may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for
exempt, non-sales roles
may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
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!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
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 identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
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.
US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove
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:
The Associate Design Assurance Director will ensure that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system. The Design Assurance (DA) Associate Director will work with the existing DA teams to: Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product. Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Exceed customer expectations by responding to field events in a professional and timely manner. Minimize the number of field events by building in quality into the design, through effective analysis of returned products, corrective actions and timely investigation and response to field events and post market monitoring through post market surveillance activities.
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities will include: Recruits, coaches and develops organizational talent. Manages both NPD, Sustaining and VIP activities with existing DA teams. Represent QA in internal and external audits as a facilitator and SME. Works closely with PMO to ensure the division is properly resourced to support projects Drives PIRs, may own or contribute to the PIR process/document. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Creates an entrepreneurial environment. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees. Keeps the organization's vision and values at the forefront of decision making and action. Demonstrates effective change leadership. Builds strategic partnerships to further departmental and organizational objectives. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Monitors compliance with company policies and procedures (e.g. compliance with FDA, TUV, EUMDR regulations, etc.). Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives. Required qualifications:
Bachelor's degree (Engineering) Minimum of 7 years of Design Assurance Minimum of 5 years of supporting product development Minimum of 8 years of leadership experience Minimum of 10 years' experience in medical devices Solid understanding of US and OUS regulations and requirements for product development Preferred qualifications:
Master's degree (Engineering) 10 years of DA experience 15 years in Product Development (medical devices) 10 years of leadership experience Prior experience in Process Development, PMO, Reliability, Complaints handling Experience with complex capital equipment Experience with product that include Software or embedded firmware Experience with active implantable devices
Requisition ID: 601142
Minimum Salary: $ 140000
Maximum Salary: $ 266000
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--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.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for
non-exempt (hourly), non-sales roles
may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for
exempt, non-sales roles
may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
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!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
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 identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
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.