资深设计质量工程师（全球扩展）
Staff Design Quality Engineer (Global Expansions)
公司简介
Dexcom 公司（纳斯达克股票代码：DXCM）是连续血糖监测（CGM）领域的先驱和全球领导者。Dexcom 从一家小公司起步，怀揣着一个宏大的梦想：永远改变糖尿病的管理方式。解锁信息和洞察力，以改善健康结果。25 年后的今天，我们开创了一个行业。而我们才刚刚开始。我们正在将视野扩展到糖尿病之外，赋能人们掌控自己的健康。这意味着面向重要健康挑战的个性化、可操作的洞察力。继续我们已开启的事业：改善人类健康。
我们由成千上万有抱负、充满热情的人组成，他们愿意像战士一样奋斗，通过倾听、诚信服务、大胆思考和值得信赖来赢得客户的信任。我们已经改变了数百万人的生活，我们准备改变更多。我们的未来目标是成为领先的消费健康科技公司，同时继续开发针对严重健康状况的解决方案。我们将通过不断重塑独特的生物传感技术体验来实现这一目标。尽管我们已从初创公司走得很远，但我们的梦想比以往任何时候都更大。在全球范围内改善健康的机遇就在我们面前。
团队介绍：
Staff Design Quality Engineer（全球拓展）负责在国际市场中担任设计控制、产品风险管理及法规合规性的主要技术权威。该职位对推动区域适应性、平台扩展和新旧产品的本地化至关重要。理想的候选人确保本地设计要求完全融入我们的全球产品开发生命周期。
与系统工程、设计工程、临床、法规事务、质量、制造、人因工程和上市后监测跨职能协作，该职位将全球医疗设备法规——包括 FDA 21 CFR Part 820/QMSR、ISO 13485、欧盟 MDR、ISO 14971 等——整合到产品开发过程中，同时确保患者安全和法规合规性。
你的职责：
- 担任主题专家（SME），负责将设计历史文件（DHFs）与目标国际市场的合规要求对齐
- 担任核心团队负责人（质量负责人），负责评估变更控制、纠正预防措施（CAPA）和不符合项对整个系统的影响
- 担任
查看英文原文
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
TheStaff Design Quality Engineer (Global Expansions)serves as the principal technical authority for design control, product risk management, and regulatory compliance across international markets. This role is vital for driving the regional adaptation, platform expansion, and localization of new and existing products. The ideal candidate ensures that local design requirements are fully integrated into our global product development lifecycle
Working cross-functionally with Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance, this role integratesglobal medical device regulations– including FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971etc-into product development while ensuring patient safety and regulatory compliance.
Where you come in:
- You willserve as the subject matter expert (SME) responsible for aligning Design History Files (DHFs) with the compliancerequirements of target international markets
- Youwill act as the core team leadQuality Lead responsible forassessing the impact of change controls, CAPA’s andNon Conformance’son the overall system
- You will serve as the lead Quality contact for requests from regulatory agencies as part of global expansions
- You will act as theQuality Lead responsible for supporting investigations from CAPA’s and complaint investigations
- You will serve as the Quality Lead responsible foridentifying, prioritizing, communicating, and resolving quality issues
What makes you successful:
- You have proven experience in Design Quality Engineering and Assurance within the medical device industry.
- You must have a minimum of 8+ years of experience in medical device development.
- You bring at least 5+ years in leading and implementing global expansions in medical device development
- Youdemonstrateanability to collaborate with cross functional teams.
- Youpossessexceptional interpersonal, written, and verbal communication skills.
- You are self-motivated with a collaborative, proactive, and accountable approach
Whatyou’llget:
- A front row seat tolife changingCGM technology.Learn about our brave #dexcomwarriors community.
- Afull andcomprehensive benefitsprogram.
- Growth opportunities on a global scale.
- Access tocareer development through in-house learning programs and/orqualifiedtuition reimbursement.
- Anexcitingandinnovative,industry-leading organizationcommitted to our employees,customers, and the communities we serve.
Travel Required:
- 5-15%
Experience and Education Requirements:
- Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8-12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
RemoteWorkplace:Your location will be a home office; youare not required tolive within commuting distance of your assigned Dexcom site (typically 75 miles/120km).If youresidewithin commuting distance of a Dexcom site (typically 75 miles/120km)a hybridworking environment may be available. Ask about our Flex workplaceoption.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at .
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at .
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided:
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.
Salary:
$111,100.00 - $185,100.00
#DexcomUS
Originally posted on Himalayas