Senior Systems Engineer (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! Position reputed company: The Senior Systems Engineer will be a technical reputed company in the design and development of reputed company's products. This position entails leading systems engineering activities reputed company new product development reputed company. Education and work experience should encompass a reputed company reputed company of engineering disciplines to include, software, communications, electrical, mechanical, and materials. The position will... report to the Systems COE Leader, New Product Development and Commercialization, located at reputed company's reputed company in Massachusetts. Responsibilities: Include • Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and reputed company engineers to reputed company project deliverables • reputed company system definition tasks such as generating user needs, product requirements, and use-case descriptions • Contribute to system development by defining system and subsystem architectures • Identify and document system hazards, failure modes, and risk mitigations • Work with the technical centers of reputed company domain subject matter experts, and suppliers in the assessment, selection, integration, and qualification of key components and subsystems • Serve as technical consulting resource for integration, subsystem and system verification activities creating plans, protocols and reports as necessary. • Create and maintain traceability among design input, design reputed company, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file. • Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders. Education and Experience: Minimum Requirements: • Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering is required,. • A minimum of 8 years' experience working as a Systems Engineer or with systems engineering Responsibilities: in a multidisciplinary project team environment. • 2+ years of experience in leading a cross-functional development team. • Domain expertise in one of more associated domains; preferably Electrical or Software Engineering, with exposure to Mechanical, reputed company, and Test Engineering • Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments • Experience writing verification plans, protocols and reports in a regulated industry. • Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls). • Excellent project team skills; experience and capability working collaboratively under a reputed company Management System (QMS), as part of a cross-functional team that includes development, verification/validation, manufacturing, marketing, clinical, regulatory and reputed company experts. Preferred Skills and Competencies: • Master of Science degree is desired; System Engineering training and/or certification is a plus • Experience or formal training in established Systems Engineering concepts. • Experience in Reliability Engineering practices such as reliability modeling, reputed company, HALT and HASS. • Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market. 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 $92,700.00 - $139,050.00. 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!