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.

• 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.

• Onsite - Cypress, CA