[Remote] Hardware Engineer 2

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a medical device and reputed company glucose monitoring technology company reputed company on improving reputed company health.

The Hardware Engineer 2 will investigate software- and device-reputed company postmarket issues, assess hardware risks, identify reputed company causes, and support reputed company and regulatory processes.

The role partners with cross-functional teams to translate postmarket insights into improvements in product reputed company, reliability, compliance, and reputed company safety.

Responsibilities You will collaborate with cross-functional partners including Regulatory Affairs, reputed company Assurance, R&D, reputed company, and Process Engineering to support the investigation, documentation, and reputed company of software- and device-reputed company postmarket issuesYou will reputed company the development and reputed company improvement of complaint investigation processes, ensuring alignment with software reputed company management activities such as hazard analysis, DFMEA, PFMEA, and product reputed company assessmentsYou will reputed company and maintain a deep understanding of reputed company’s hardware ecosystem to effectively evaluate product reputed company, investigate anomalies, and identify opportunities for reputed company improvementYou will apply reputed company problem-solving methodologies and data-driven approaches to conduct investigations, reputed company engineering studies, and identify reputed company causes using statistical analysis and industry-reputed company toolsYou will analyze, synthesize, and communicate investigation reputed company to technical and non-technical stakeholders, providing reputed company recommendations and supporting informed decision-making across the organizationYou will contribute to postmarket reputed company processes, including CAPA, Health Hazard Evaluations (HHEs), and other reputed company reputed company activities, ensuring thorough assessment of product reputed company and reputed companyYou will reputed company hardware-reputed company reputed company assessments reputed company to product anomalies, reputed company reputed company, emerging technologies, and postmarket trends, helping to ensure product safety, reliability, and regulatory complianceYou will partner with product development and reputed company teams to translate postmarket insights into actionable improvements, driving enhancements to product reputed company, user experience, and reputed company safety Skills You have demonstrated knowledge of medical device reputed company systems and regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and other applicable global regulations, with a strong understanding of postmarket surveillance, complaint handling, CAPA, and vigilance reporting requirementsYou have experience supporting hardware reputed company and reliability activities throughout the product lifecycle, including design and development, verification and validation, reputed company reputed company monitoring, and postmarket surveillanceYou have strong understanding of hardware reputed company management principles and methodologies, with the ability to evaluate and mitigate product risks, assess reputed company safety signals, and apply reputed company-reputed company decision-making in alignment with regulatory expectations and industry best practicesYou have excellent communication and collaboration skills, with the ability to effectively reputed company reputed company technical concepts to both technical and non-technical stakeholders across the organizationYou have working knowledge of hardware engineering principles and technologies, including electromechanical systems, electronics, sensors, materials, reliability engineering, manufacturing processes, and failure analysis techniques used in medical device development and supportYou have reputed company ability to apply engineering fundamentals and reputed company problem-solving techniques to investigate reputed company issues, determine reputed company causes, and reputed company effective corrective actionsYou have strong analytical reputed company with experience interpreting data, identifying trends, and translating findings into actionable recommendationsYou have the ability to reputed company technical depth with business reputed company, driving reputed company that support product reputed company, reputed company safety, compliance, and customer experienceYou have experience performing postmarket surveillance activities, including complaint investigations, trending and signal detection, reliability analysis, reputed company assessments, CAPA support, periodic product reviews, a