iRhythm Technologies, Inc. razvija digitalne zdravstvene rešitve za diagnosticiranje in obravnavo srčnih aritmij. Njena platforma ZioSuite združuje zbiranje podatkov, osredotočeno na pacienta, z napredno analitiko, da podpira spremljanje srca in zdravstvenim delavcem pomaga učinkoviteje ocenjevati zdravje srca. Podjetje deluje na stičišču medicinske tehnologije in digitalne oskrbe ter se osredotoča na izboljšanje odkrivanja in obravnave nepravilnega srčnega ritma.
Director of Design Quality
Lead design quality for iRhythm’s wearable cardiac health technology, guiding medical device compliance, risk management, software quality, and Design Quality Engineering teams.
Združene države Amerike182.000 $ – 237.000 $ / leto
Na daljavoPolni delovni časVodjaZahtevani Jezik: angleščinaUmetniški direktorOpis
- Lead and staff Design Quality Engineering teams across hardware and software.
- Oversee design controls, design transfer, risk management, verification and validation, human factors, and product lifecycle activities.
- Work with cross-functional leaders to set quality strategies, requirements, decision points, and escalation paths.
- Strengthen design-related Quality Management System processes, metrics, and governance.
- Use complaint, field performance, and post-market data to identify product risks and prevent recurrence.
- Represent Design Quality in FDA inspections, Notified Body audits, regulatory discussions, and executive management reviews.
- Maintain compliance with FDA requirements, international regulations, and medical device standards.
- Promote a collaborative quality culture focused on patients and customers.
- Recruit, coach, and develop leaders and teams, including succession and capability planning.
- Report quality risks, performance, resources, and improvement priorities to executive leadership.
- Carry out other assignments as directed by management.
Zahteve
- At least 15 years of related experience and a bachelor’s degree, including experience in medical, science, or healthcare fields, or equivalent experience.
- At least five years of management experience with direct reports.
- Expert knowledge of design controls, Critical-to-Quality strategies, risk management, cybersecurity, and related disciplines.
- Knowledge of mechanical, electrical, and software engineering for complex device development.
- Knowledge of software development lifecycles covering embedded software and firmware, applications, and analytics.
- Experience with software quality for mobile apps and remote installation is an advantage.
- Ability to collaborate and build positive relationships and trust across disciplines.
- Experience with AI-based devices, Software as a Medical Device (SaMD), or wearable medical devices is preferred.
- A master’s or other advanced degree is preferred.
- Knowledge of FDA requirements, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 62366, EU MDR, and other applicable international regulations and standards.
Ugodnosti
- Medical, dental, and vision coverage beginning on the first day.
- Paid holidays.
- Paid time off.
- 401(k) with company match.
- Employee stock purchase plan.
- Paid parental leave.
- Pet insurance discount.
- Cultural committee and charity events.
- Reasonable accommodations for qualified individuals during the job application process.