Boston Scientific
Associate Design Assurance Director
Boston Scientific, California, Missouri, United States, 65018
Additional Location(s)
US-MN-Arden Hills; US-MN-Maple Grove
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.
Responsibilities
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 5 years of Design Assurance
Minimum of 5 years of leadership experience
Preferred qualifications
Master's degree (Engineering)
Minimum of 5 years of supporting product development
Minimum of 10 years' experience in medical devices
Solid understanding of US and OUS regulations and requirements for product development
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
Salary Minimum Salary: $140000
Maximum Salary: $266000
Relocation This position is based in Valencia, CA. For the qualified candidate that meets our expectation, there is the opportunity to relocate to Valencia for a minimum of 1 year and then relocate back to your prior BSC location.
Visa Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Equal Employment Opportunity 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.
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.
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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.
Responsibilities
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 5 years of Design Assurance
Minimum of 5 years of leadership experience
Preferred qualifications
Master's degree (Engineering)
Minimum of 5 years of supporting product development
Minimum of 10 years' experience in medical devices
Solid understanding of US and OUS regulations and requirements for product development
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
Salary Minimum Salary: $140000
Maximum Salary: $266000
Relocation This position is based in Valencia, CA. For the qualified candidate that meets our expectation, there is the opportunity to relocate to Valencia for a minimum of 1 year and then relocate back to your prior BSC location.
Visa Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Equal Employment Opportunity 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.
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.
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