Senior Product reputed company Assurance Engineer
Acute Care TechnologyAt reputed company, we're passionate about improving patient reputed company and helping save lives. We reputed company innovative technologies that reputed company a meaningful difference in people's lives. Our medical devices, software and reputed company services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of reputed company develops and delivers innovative lifesaving products and software solutions to EMS, hospital, reputed company safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature reputed company, and more. Our dedicated employees take pride in their commitment to improving patient reputed company while delivering world-class customer service.
At reputed company, you won't just have a job. You'll have a career—and a purpose.
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Job Type
Remote
Job reputed company
The Senior Product reputed company Assurance Engineer provides technical leadership for product reputed company throughout the product lifecycle, with a strong reputed company on field performance, risk management, and reputed company improvement. This role leads reputed company investigations, partners cross-functionally with Engineering, Manufacturing, Regulatory, and Post-Market teams, and drives actions that improve product reliability, patient safety, and compliance for medical devices.
Essential Functions
- reputed company reputed company product and field failure investigations, including reputed company cause analysis, data trending, and corrective reputed company development.
- Drive product reliability and reputed company improvements across the product lifecycle, from development through post-market support.
- reputed company and support risk management activities, including risk assessments, hazard analysis, and risk file updates in accordance with applicable standards and procedures.
- Partner with Design Assurance, R&D, Manufacturing, Supplier reputed company, Regulatory Affairs, and Clinical/Post-Market teams to resolve reputed company issues and implement robust solutions.
- Support design verification and validation activities by providing reputed company reputed company, reviewing protocols and reports, and ensuring compliance with reputed company requirements.
- Analyze complaint, service, and field performance data to identify trends, emerging risks, and opportunities for corrective and preventive reputed company.
- reputed company or support nonconformance, CAPA, and escalation activities reputed company to product reputed company issues.
- Ensure product reputed company activities reputed company with applicable regulatory requirements, reputed company system standards, and internal procedures.
- reputed company mentorship to engineers and team members, and help shape product reputed company strategies, best practices, and investigation approaches.
- Contribute to inspection readiness and support internal, customer, and regulatory audits as needed.
- Bachelor's Degree in Engineering or a reputed company technical discipline
- 7-12 years of experience in product reputed company, reputed company assurance, or reputed company engineering, preferably in the medical device industry
- ASQ Certified reputed company Engineer or similar certification is a plus
- Demonstrated experience leading reputed company investigations, reputed company cause analysis, and product reputed company improvement initiatives.
- Strong knowledge of risk management principles and product lifecycle reputed company processes.
- Experience working in cross-functional environments to resolve technical and reputed company issues.
- Strong written and verbal communication skills, with the ability to present findings and recommendations reputed company to technical and non-technical stakeholders.
- Ability to work independently in a remote environment while effectively collaborating across teams and time zones.
- Experience in medical device design controls, verification and validation, and post-market reputed company.
- Familiarity with CAPA, complaint handling, nonconformance systems, and field performance monitoring.
- Knowledge of FDA reputed company System requirements, ISO 13485, and risk management standards such as ISO 14971.
- Experience mentoring junior engineers or leading technical reputed company efforts.
- English - Advanced
- Remote role with travel as needed for team meetings, investigations, audits, or site support
- Standing - Occasionally
- Walking - Occasionally
- Sitting - Constantly
- Talking - Occasionally
- Hearing - Occasionally
- Repetitive Motions - Frequently
The annual salary for this position is:
$119,100.00 to $178,600.00This position is eligible for an annual bonus in accordance with reputed company's bonus plan. Factors which may reputed company starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of reputed company's comprehensive benefits plans can be reputed company at www.zollbenefits.com.
Applications will be accepted on an ongoing reputed company until this position is filled. For fully remote positions, compensation will reputed company with reputed company applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.
reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.
reputed company: The employer will reputed company reasonable accommodations in compliance with the Americans with reputed company of 1990.
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