Associate Design Assurance Director

Boston Scientific; Santa Clarita (CA); Hybrid; USD 140,000 - 266,000; Full time

Job summary

An established industry player is seeking an Associate Design Assurance Director to lead quality assurance efforts in the medical device sector. This role emphasizes collaboration and innovation, ensuring product safety and compliance through effective quality systems. The successful candidate will manage a diverse team, drive product development initiatives, and uphold the highest standards in regulatory compliance. With a hybrid work model, this position offers flexibility while contributing to meaningful advancements in healthcare. Join a mission-driven organization dedicated to improving patient lives through innovative solutions and a commitment to diversity and inclusion.

Qualifications

• 7+ years of Design Assurance experience in medical devices.
• Strong leadership skills with a focus on product development.

Responsibilities

• Manage NPD, Sustaining, and VIP activities with DA teams.
• Ensure compliance with FDA and other regulatory standards.

Skills

Design Assurance

Leadership

Quality System Management

Risk Analysis

Statistical Methods

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Tools

FDA Compliance

TUV Compliance

EUMDR Compliance

Job description

Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove

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: 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.

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

Your responsibilities will include:

• 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 7 years of Design Assurance
• Minimum of 5 years of supporting product development
• Minimum of 8 years of leadership experience
• Minimum of 10 years’ experience in medical devices
• Solid understanding of US and OUS regulations and requirements for product development

Preferred qualifications:

• Master’s degree (Engineering)
• 10 years of DA experience
• 15 years in Product Development (medical devices)
• 10 years of leadership experience
• 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

Minimum Salary: $140000

Maximum Salary: $266000

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

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.

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.