Sr. Manager, Design Quality Engineering - Product Compliance

Description

The company is a global leader in continuous glucose monitoring (CGM), founded 25 years ago, and is now expanding beyond diabetes into personalized, actionable health insights.

The Design Quality Engineering (DQE) team drives Design for Excellence (DfX) methods across the lifecycle of current on-market products and future innovations. It also leads strategy and delivers outcomes across the Design Control, Software Development Lifecycle (SDLC), Design Transfer and Risk Management quality system processes.

Responsibilities

• Serve as the accountable Quality leader for electrical safety, electromagnetic compatibility (EMC) and radio certifications across the full product lifecycle.
• Own the global compliance strategy for IEC 60601 electrical safety and EMC standards across the CGM portfolio, so requirements are built in from the start.
• Work directly with Nationally Recognized Testing Laboratories (NRTLs) on strategy, including on-site testing support.
• Lead worldwide radio certification and market access for wireless medical devices, securing approvals and keeping them maintained in every market.
• Set up and manage the process for monitoring external standards and assessing their impact, turning changing regulatory and industry rules into product and quality system plans.
• Provide quality engineering leadership for compliance work across development, commercialization, sustaining engineering, post-market monitoring and product changes.
• Align Regulatory Affairs, R&D, Clinical, Manufacturing and external certification bodies early to manage compliance risk and support business goals.
• Resolve escalations, guide teams to solutions, and make Quality decisions for your assigned platforms.
• Build strong, supportive, collaborative relationships with cross-functional peers and leaders.
• Lead, organize, develop and grow a team of Compliance Engineers, making sure project teams get the quality engineering support they need.
• Represent the organization in regulatory audits and inquiries.

Requirements

• Have demonstrated leadership in working with NRTLs on medical device certification strategies, and with local regulators worldwide on radio certifications.
• Adapt to shifting priorities and manage several initiatives at once.
• Communicate exceptionally well in writing, verbally and interpersonally.
• Be self-motivated, and approach work collaboratively, proactively and with accountability.
• Typically hold a Bachelor's degree with 13+ years of industry experience, and a degree in a technical discipline.
• Have 5-8 years of previous people management experience.
• Preferred: a Bachelor's degree in Engineering.

Conditions

Travel of 15-25% is required.

Flex workplace: your primary location is a home office with no assigned workstation. You will agree office visit needs with your manager.

You must live within commuting distance of your assigned the company site, typically 75 miles/120km.

Pay range: $141,800.00 - $236,400.00.

Listed under the DexcomUS entity.

AI supported tools may assist the hiring process, but people make every hiring decision.

Benefits

• Learn about the employee community that is central to the company's CGM work.
• A full, comprehensive benefits program.
• Growth opportunities on a global scale.
• Career development through in-house learning programs and/or qualified tuition reimbursement.