Senior Design Assurance Manager - WATCHMAN

Additional Location(s): US-MN-Maple Grove; Ireland-Galway

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 Senior Design Assurance Manager to lead a team of engineers in the Watchman franchise responsible for developing and sustaining implantable and single use devices for use in Left Atrial Appendage Closure.  The role will interact with Quality peers in Minnesota, Ireland and Costa Rica.

The Senior Design Assurance Manager will provide DA leadership and lead a team of skilled Engineers.  This Senior Design Assurance Manager will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management.  This Senior Design Assurance Manager will be a key partner to the Research & Development, Medical, Regulatory, Marketing and Manufacturing Engineering teams in achieving new product development, commercialization and product sustainment within Interventional Cardiology (IC), which is a rapidly growing division of BSC.   

Work mode:

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Maple Grove, MN and requires being on-site at least three days per week. We will also consider candidates based in our Galway, Ireland location.

Relocation assistance:

Relocation assistance may be available for this position at this time.

Visa sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Responsibilities include:

• Key Quality voice of influence on sustaining projects and cross functional CAPA product investigations.
• Leads quality team on functional deliverables and ensures technical excellence for product or technical development in the achievement of organizational goals.
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance
• Owns and drives commercial product monitoring and all related product sustainment activities.
• Develops and implements quality strategies; seeks innovative approaches to attaining quality goals.
• Driving functional excellence in Design Assurance (DA) by developing, coaching, mentoring, and leadership on product design changes, while ensuring technical excellence.
• Develops department budget and monitors spending. 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.
• Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Directly interfaces with internal and external audit activities.

Required Qualifications:

• Minimum of a Bachelor's degree 
• Minimum of 7 years of related work experience or an equivalent combination of education and work experience
• Minimum of 5 years of direct or indirect supervisory experience with a passion for leadership and team development
• Medical Device or regulated industry experience.
• Applied experience in test method development, risk management and other design control processes.
• Ability to travel up to 10%

Preferred qualifications:

• Advanced degree in technical field or business 
• Experience leading technical teams
• Regulatory compliance experience in the areas of medical devices, combination products, pharmaceuticals, and analytical methodology
• Experience in cardiology applications involving nitinol and catheter-delivery systems.

Requisition ID: 628817 

Minimum Salary: $ 125800 

Maximum Salary: $ 239000 

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.

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 45 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 healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

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.