Manager, Post Market Engineering

Career-defining. Life-changing. 

At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

About this role: 

iRhythm Technologies, Inc. is looking for a Manager, Post Market Engineering to join the Quality team. The Post Market Engineering Manager will oversee the Post Market Quality Engineering team to ensure compliance, accuracy, and efficiency, including oversight over a Complaints Lab.  The position will also provide data and analysis to support Quality department as needed. 

Responsibilities:

• Provide supervision and leadership to a team of Quality Engineers and Complaints Technicians.
• Manage and balance assignment of work to team to meet goals.
• Provide guidance, development and performance feedback and opportunities for growth through regular one-one-one and team meetings.
• Annual Performance reviews with quarterly check-ins
• Establish and maintain documented laboratory procedures
• Manage and update testing methods, techniques and equipment, as needed
• Review investigated complaints to ensure procedural and regulatory compliance.
• Ensures complaints are closed in a timely manner, ensures all global medical device reports are submitted within regulatory timeframes.
• Manages projects associated with the Complaint Handling process
• Participates in process improvements to improve compliance, effectivity, and efficiency, and takes ownership for updating procedures and policies.
• Perform other quality and regulatory-related duties as assigned.

Required Qualifications:

• Bachelor’s Degree or Associate Degree in science, technology or medical fields
• 8+ years of experience in Quality Assurance and / or a complaint processing role, experience with Medical Device Reporting.
• Supervisory or Manager experience in a medical device company
• Strong working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
• Strong interpersonal and organizational skills to enable working cross-functionally within the organization,
• Strong problem-solving skills, critical-thinker, and experience at investigating and resolving complex issues.
• Understand basic principles of good technical writing skills and be able to articulate findings and formulate conclusions.
• Identify problems and lead projects to improve processes, procedures and/or practices; recommend and resolve solutions.
• Excellent communication (verbal and written) and interpersonal skills required.
• Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems.
• Must be able to work under minimum supervision and in a team environment.

Work Environment

• Onsite - Cypress, CA

Location:

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [email protected]

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121