Senior Design Quality Assurance Manager - Endoscopy

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 for a Senior Design Quality Assurance (DQA) Manager to lead a Capital Equipment DQA team in our Marlborough, MA location. This Senior DQA Manager will provide leadership to a team of quality engineers in the Endoscopy division, with skillset centered around mechanical / electrical / systems engineering, software quality and cybersecurity. They will be responsible for ensuring product quality and compliance through the application of Design Control and Risk Management principles across product life cycle.  This role will be a key partner to Research & Development, Regulatory, Medical Safety, Supplier Engineering and external vendors.

The successful candidate will excel at building strong networks and understanding the interdependencies across global operations. They will influence a diverse set of stakeholders, manage and develop a Design Assurance Quality team in Sustaining and New Product Development.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Marlborough, MA office at least three days per week.

Relocation assistance is available for this position at this time. 

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

Your responsibilities include:

• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Oversees the Design Controls and Risk Management aspects of Design History File, mitigate risks and ensure compliance with applicable regulatory standards during New Product Development.
• Translate strategy into action by converting broader organizational goals into specific objectives and tactical plans for the Quality Engineering team. Key focuses include New Product Development projects and goals, complaint reduction, value improvement and product performance challenges.    
• Owns and drives commercial product monitoring and all related product sustainment activities including complaint signal management, CAPA and management of regulator responses.
• Communicate effectively. Interacts with and influences stakeholders at all levels of the organization, presenting complex challenges in clear and actionable manner.
• Act as a champion for quality disciplines, decisions, and practices. Lead in guiding team direction and execution of product and divisional programs. Promote accountability and a proactive mindset toward excellence.
• Provides guidance and leadership to team of direct reports on workload management, priorities, and project execution. Provides mentorship in quality technology, quality principles and overall regulation, risk management and design control concepts. 
• Continuously develops direct reports through individual development planning processes.
• Determines appropriate staff levels and schedules.  Works with key partners to understand priorities and plans resource allocation accordingly.
• Assures activities and deliverables in area of responsibility meet regulatory and corporate requirements.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Directly interfaces with internal and external audit activities including direct audit support locally and at several international manufacturing sites. 
• Partners with internal and external stakeholders and vendors to ensure quality objectives are met and to provide solutions to quality issues.

 
Required Qualifications

• Minimum of a bachelor’s degree in engineering (Electrical, Computer Engineering, Mechanical, Biomedical, etc.) or equivalent fields of study
• Minimum of 8 years of related work experience in Design Quality or an equivalent combination of education and work experience
• Minimum of 3 years of direct or indirect supervisory experience with a passion for leadership and team development
• Medical Device or regulated industry experience
• Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls, risk management and design optimization
• Ability to travel up to 10% (Domestic and International)

 
Preferred qualifications

• Advanced degree in technical field or business. Preferable experience with electro-mechanical products, systems and / or software engineering
• Experience leading technical teams
• Strong strategic and critical thinking capabilities with the ability to balance long-term vision with executional excellence
• Excellent collaboration, communication, and interpersonal skills with the ability to work across cultures and geographies
• Ability to drive change in a matrixed, global organization
• Experience with problem solving including Six Sigma Certification(s)
• Strong communication skills (verbal & written) in a technical environment

Requisition ID: 616687 

Minimum Salary: $ 127900 

Maximum Salary: $ 243000 

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.