Senior Design Assurance Manager - Reliability and Field CAPA - CRMDx

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 a Senior Design Assurance Manager to lead our Reliability and Field CAPA teams at the Arden Hills, MN location in the Cardiac Rhythm Management & Diagnostics (CRMDx) division.  This is an exciting and rewarding opportunity to lead this Design Assurance team, in collaboration with our cross-functional partners, developing and sustaining lifesaving and life-enhancing technologies for patients with rhythm disorders and heart failure from diagnosis to treatment, including Cardiac Implantable Electronic Device (CIED) systems, Medical Electrical Equipment (MEE), Remote Patient Monitoring (RPM) systems, and Single Use Devices (SUDs).  The Senior Design Assurance Manager will lead this Reliability and Field CAPA team, who are 1) driving reliability understanding of products during development and commercialization through use environment characterization and product performance characterization and 2) leading cross functional teams to determine actionable root cause and implement effective solutions for issues impacting commercial product performance, in close partnership with Research & Development, Regulatory, Medical, Marketing, Manufacturing Engineering, and Project Management.

Your responsibilities will include:

• Leads a team of employees in the achievement of organizational goals, project goals, and career goals.  Recruits, hires, supports, and develops a high performing team.
• Lead team of Reliability Engineers.  The Reliability Engineers lead or support engineering evaluations and analyses for products in development and commercialized products in areas including, but not limited to 1) use environment characterization, 2) failure modes and mechanisms identification, 3) simulation and analyses creation, 4) test method and requirements development, 5) design guideline development, and/or 6) knowledge capture.  The Reliability Engineers maintain a lab with sophisticated test systems, while also evaluating/procuring/developing new cutting-edge technologies, to facilitate their own and their cross-functional partners’ evaluations. 
• Lead team of Field CAPA Engineers.  The Field CAPA Engineers lead cross-functional teams through the Corrective and Preventive Action (CAPA) process to determine actionable root cause and implement effective solutions for issues impacting commercial product performance, where suspected/confirmed root cause is product design.  This includes recruiting and leading cross-functional teams, leading cross-functional team meetings, driving efficient and effective problem solving (includes root cause identification, solution development/recommendation, solution implementation strategy development/support, and solution effectiveness verification), and presenting updates in formal and informal reviews with all levels of the organization.
• Develops and implements quality strategies; seeks innovative approaches to achieving quality goals.
• Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• Maintains and enhances cross-functional team relationships.
• Develops department budget and monitors spending.  Determines appropriate staff levels and schedules.  Works with cross-functional partners to understand priorities and plans resource allocation accordingly.
• Monitors and ensures compliance with company policies and procedures (e.g. federal/country and regulatory requirements).  May serve as liaison between the company and the various governmental agencies worldwide.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

What we’re looking for:
Required qualifications:

• Minimum of a Bachelor's degree in engineering or science
• 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

Preferred qualifications:

• Advanced degree in engineering, science, or business
• Experience leading technical teams
• Experience leading problem-solving teams
• Experience presenting complex technical content to all levels of the organization with varying levels of technical expertise
• CAPA, FMEA, and/or Reliability experience
   

Requisition ID: 602465 

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 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.