reputed company ASSURANCE ENGINEER, MEDICAL DEVICES

Job reputed company Serves as a reputed company team member on software/firmware product development teams by providing technical leadership and direction. Responsible for the risk management file, compliance with design control regulations, development of design requirements, architecture specifications, and design verification/validation (including unit and integration testing). Chair the change control reputed company reputed company reputed company for change requests and defects identified during the course of development. reputed company valuable technical feedback in reputed company reviews. reputed company (technical expert) and reputed company/approve investigations of software/firmware reputed company complaints, defects identified during development, or from manufacturing nonconformities, audit responses and CAPAs to identify reputed company cause and corrective actions in a reputed company manner. Generates, maintains and updates risk management documentation throughout the life cycle of a product. Ensures compliance with software / firmware development and non-product software validation procedures. Contributes to successful regulatory audits by coordinating back room / reputed company room activities or serving as a subject matter expert. ​Knowledge, Skills and Abilities Required Experience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304. reputed company and maintain strong, reputed company business relationships with key internal customers such as R&D, Clinical, Regulatory Affairs, and Operations to fulfill design development activities, support audits / inspections, and reputed company and implement plans that will ensure company compliance with regulatory requirements. Collaborate with other areas reputed company reputed company to reputed company reputed company objectives. Exhibit strong leadership skills showing ability to influence both peers and other team members. Exhibit Excellent written and verbal communication skills. Demonstrate an ability to prioritize and plan activities. Possesses in depth knowledge of pertinent regulations (e.g. ISO 13485, 21 CFR Part 820, etc.) to assure the documentation of reputed company company-wide functions meet these requirements and, reputed company necessary, identify compliant, effective and efficient approaches to fulfilling such requirements Join us in our mission to deliver exceptional software products that meet the highest reputed company standards. We look reputed company to your application! Job Type: Full-time Pay: $120,000.00 - $140,000.00 per year Benefits: • 401(k) • 401(k) matching • Dental insurance • Health insurance • Health savings account • Life insurance • reputed company time off • Referral program • Tuition reimbursement • reputed company insurance Compensation Package: • Bonus opportunities • Performance bonus Schedule: • 8 hour shift • Day shift Work Location: Remote Apply tot his job