Senior Design Quality Assurance Manager

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 :

This is an exciting opportunity for a Senior Design Assurance Manager to join a cross-functional leadership team on the new

Renal Denervation

business within BSC's Cardiology division. This position will support the significant new

Renal Denervation

acquisition integration and product development program with high visibility which will provide the right candidate with excellent growth and development potential.

The Senior Design Assurance Manager will provide DA leadership for

Renal Denervation

Medical Electrical Equipment (Capital Equipment and Software) and lead a team of skilled Engineers. They will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management. They will be a key partner to the Research & Development, Regulatory, Marketing and Manufacturing Engineering teams in achieving acquisition integration, new product development, commercialization and product sustainment for

Renal Denervation .

At Boston Scientific, we value collaboration and synergy. This role requires employees to be in our Arbor Lakes, MN office four 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 include :

Leads quality team on product / system development projects of major magnitude and scope. Key Quality voice of influence on projects.

Leads quality team on functional deliverables and ensures technical excellence for product or technical development.

Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives. Including leading V&V activities and failure investigations.

Owns and drives commercial product monitoring and all related product sustainment activities.

Develops and implements quality strategies; seeks innovative approaches to attaining quality goals.

Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.

Develops department budget and monitors spending.

Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.

Maintains and enhances cross-functional team relationships.

Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.

Lead a team of employees in the achievement of organizational goals. Coach, direct, and develop a high performing team.

Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

Monitor and ensure compliance with company policies and procedures (e.g. federal / country and regulatory requirements).

Directly interfaces with internal and external audit activities.

Required qualifications :

Bachelor's degree in engineering or related field

Minimum of 7 years of related work experience

Minimum of 5 years of direct or indirect management experience with a passion for leadership and team development

Medical Device or regulated industry experience

Preferred qualifications :

Advanced degree in technical field or business

Experience leading technical teams

Prior R&D experience

Regulatory compliance experience in the areas of medical devices, electrical products and analytical methodology

Understanding of applicable electrical safety standards and configuration management

Experience in reliability testing, software testing, cybersecurity testing

Requisition ID : 614225

Minimum Salary : $ 122100

Maximum Salary : $ 232000

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 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.