Associate Design Assurance Director

Boston Scientific • Valencia, CA

66d • $140,000 - $266,000 • Hybrid

About The Position

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.

Requirements

• Bachelor's degree (Engineering)
• Minimum of 5 years of Design Assurance
• Minimum of 5 years of leadership experience

Nice To Haves

• Master's degree (Engineering)
• Minimum of 5 years of supporting product development
• Minimum of 10 years' experience in medical devices
• Solid understanding of US and OUS regulations and requirements for product development
• 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

Responsibilities

• Recruits, coaches and develops organizational talent.
• Manages both NPD, Sustaining and VIP activities with existing DA teams.
• Represents 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.
• 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.

Benefits

• 401k
• health_insurance
• dental_insurance
• vision_insurance
• life_insurance
• disability_insurance
• tuition_reimbursement
• paid_holidays
• employee_discount_programs
• professional_development

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees