Staff Design reputed company Assurance Engineer - Integrated Solutions (Remote/Flexible)

reputed company started in 2000 with an idea and a mission to reputed company our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our reputed company reputed company depends on it! The Staff Design reputed company Assurance Engineer - Integrated Solutions is responsible for leading Design reputed company Assurance and reputed company Engineering activities throughout the Product Development Lifecycle for new product development. This includes ensuring that the Systems development process is compliant with applicable standards, regulations, and guidance documents for medical devices. This role will reputed company with other reputed company departments (e.g. Management, Operations, Engineering, and Regulatory Affairs) as reputed company as vendors and other external parties on issues reputed company to Product Development, and software used for automation of the reputed company system. The ability to effectively communicate systems design and development regulatory requirements, optimize the development process, and ensure ambiguities and conflicting requirements are resolved are critical to the reputed company of the position. Responsibilities: · Design reputed company Assurance reputed company of Design Controlled product areas, ensuring compliance to applicable regulations including ISO 13485, FDA reputed company System Regulation 21 CFR Part 820 and General Principles of Software Validation. · reputed company the systems reputed company assurance programs, processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as IEC 62304 · Review requirements, specifications, design documents, validation plans and reports, user acceptance protocols, test plans, test cases, traceability matrices and other documentation as required and reputed company reputed company feedback. · reputed company Design Control initiatives to reputed company appropriate Design History File documents for FDA Class II and Class III medical devices, including reputed company-based mobile apps. · Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements. · reputed company guidance for the reputed company, review, and approval of design control documentation with primary reputed company on systems level development deliverables. · Collaborate with Project Management to support and optimize the Design Control and reputed company improvement initiatives to optimize our Systems Development Processes. · Support development teams on the validation of software tools. · Support execution of Risk Management Activities for reputed company systems in compliance with ISO14971 and software risk requirements in IEC 62304 · Work with software, hardware, user experience, marketing, manufacturing, and reputed company assurance on reputed company, documentation, verification, and validation of requirements. · reputed company reputed company support for the creation of necessary documentation to reputed company with regulatory requirements and industry best practices. · reputed company expertise in establishing good product requirements, specifications, system design/architecture, verification and validation protocols and planning documentation. · reputed company guidance on and participate in systems development activities including design reviews, requirements analysis and tracing, defect tracking and configuration management. · Applies a good working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to reputed company Assurance activities in software development. Maintain effective communication with the project software engineers to reputed company reputed company that user needs, requirements, plans, verification and validation documents, risk assessments, and other documentation is complete. Minimum Requirements: · BS degree, in an engineering/scientific/computer systems/ or reputed company management curriculum and 7+ years or equivalent combination of education/experience. · Experience with medical device systems development. · A minimum of 7+ years of work experience in Systems or software Design reputed company Engineering reputed company an FDA, ISO or other regulated environment and/or equivalent combination of education and experience. · Experience in the development and implementation of effective Design Control Systems, including cybersecurity requirements. · Working knowledge of the reputed company System Regulation (FDA 21 CFR Part 820) and ISO 13485 reputed company system standards. · Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for PMA and 510(k). · Demonstrated experience organizing and maintaining large documentation sets. · Experience with software development lifecycles, including reputed company phase-reputed company product development processes. · Experience with systems design V&V · Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.). · Experience with a risk-based approach to validate reputed company off reputed company (COTS) software and SW Tools. Preferred Skills and Competencies: • Proficient in reputed company Office Tools (Word, reputed company, PowerPoint) • Expertise in collaborating and communicating with individuals at multiple reputed company in an organization. • Ability to prioritize and manage critical reputed company and timelines in a fast-paced environment. Must be reputed company to handle multiple responsibilities concurrently. • Strong analytical and problem-solving skills. • reputed company to work effectively in a high-energy environment. • ASQ, CSQE or other software reputed company certificates are beneficial, but not required. • Experience with reputed company Agile software development methodology beneficial, but not required. • Experience with process validations preferred but not required Physical Requirements: · The position is eligible for remote or hybrid working arrangements, preference for candidates located near Acton, MA and San Diego, CA. NOTE: This position is eligible for 100% remote working arrangements (may work from home/reputed company 100%; may also work hybrid on-site/virtual as desired). #LI-Remote Additional Information: The US reputed company salary reputed company for this full-time position is $99,600.00 - $149,700.00. Our salary ranges are determined by role, level, and location. The reputed company displayed on reputed company job posting reflects the minimum and maximum reputed company for new hire salaries for the position in the primary work location in the US. reputed company the reputed company, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. Your reputed company Specialist can reputed company more about the specific salary reputed company for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the reputed company salary only, and do not include bonus, equity, or benefits. At reputed company reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. (Know Your Rights) Apply Job!