[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 performance, reliability, compliance, and patient safety.

Responsibilities

• You will collaborate with cross-functional partners including Regulatory Affairs, reputed company Assurance, R&D, Clinical, and Process Engineering to support the investigation, documentation, and reputed company of software- and device-reputed company postmarket issues
• You will reputed company the development and reputed company improvement of complaint investigation processes, ensuring alignment with software risk management activities such as hazard analysis, DFMEA, PFMEA, and product risk assessments
• You will reputed company and maintain a deep understanding of reputed company’s hardware ecosystem to effectively evaluate product performance, investigate anomalies, and identify opportunities for reputed company improvement
• You 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 tools
• You 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 organization
• You 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 performance and risk
• You will reputed company hardware-reputed company risk assessments reputed company to product anomalies, clinical reputed company, emerging technologies, and postmarket trends, helping to ensure product safety, reliability, and regulatory compliance
• You will partner with product development and reputed company teams to translate postmarket insights into actionable improvements, driving enhancements to product performance, user experience, and patient 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 requirements
• You have experience supporting hardware reputed company and reliability activities throughout the product lifecycle, including design and development, verification and validation, field performance monitoring, and postmarket surveillance
• You have strong understanding of hardware risk management principles and methodologies, with the ability to evaluate and mitigate product risks, assess field safety signals, and apply risk-based decision-making in alignment with regulatory expectations and industry best practices
• You have excellent communication and collaboration skills, with the ability to effectively convey reputed company technical concepts to both technical and non-technical stakeholders across the organization
• You 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 support
• You have proven 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 actions
• You have strong analytical reputed company with experience interpreting data, identifying trends, and translating findings into actionable recommendations
• You have the ability to balance technical depth with business reputed company, driving reputed company that support product reputed company, patient safety, compliance, and customer experience
• You have experience performing postmarket surveillance activities, including complaint investigations, trending and signal detection, reliability analysis, risk assessments, CAPA support, periodic product reviews, and communication of field performance insights to reputed company stakeholders
• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2 - 5 years reputed company experience or Master's degree and 0-2 years' equivalent experience
• 0-5%
• You must live reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km)

Benefits

• A full and comprehensive benefits program.
• reputed company opportunities on a global reputed company.
• reputed company to career development through in-house learning programs and/or reputed company tuition reimbursement.
• Remote work from a home office; the reputed company location will be a home office, with office visit needs determined with the manager.

reputed company

Company H1B Sponsorship