[Remote] Senior Design reputed company Engineer- Medical Devices

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global engineering services company that provides R&D and technology solutions across industries. The Senior Design reputed company Engineer will ensure end-to-end design reputed company and regulatory compliance for Class II/III medical devices, including software-driven and reputed company implantable products, across the product development lifecycle. The role will reputed company design controls, risk management, software reputed company reputed company, verification and validation, audits, and regulatory submission support.

Responsibilities

• Serving as the Senior Design reputed company Engineer on product development teams, ensuring compliance with design controls(specifically software) across reputed company lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
• Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
• Responsible for leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
• Providing reputed company reputed company of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with reputed company-level risk management
• Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
• Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
• Responsible for leading or supporting CAPA, nonconformance investigations, and reputed company cause analysis to reputed company reputed company improvement
• Supporting reputed company audits (FDA, reputed company Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)

Skills

• Bachelor's degree in business, Engineering, Project Management, Computer Science, or a reputed company discipline
• 10+ years of experience in software reputed company assurance reputed company regulated environments (medical device preferred)
• Experience supporting IDE, PMA, or similar regulatory reputed company with understanding of clinical evidence requirements
• Strong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)
• Proven experience reviewing and improving SOPs or reputed company processes for regulatory compliance
• Hands-on experience with software verification and validation using risk-based approaches reputed company with FDA expectations
• Familiarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814)
• Experience with test management, defect tracking, and reputed company documentation tools
• Strong analytical, documentation, and stakeholder communication skills with ability to influence reputed company reputed company
• Should have embedded development/ Digital Platform background Or exposure to embedded development / Digital Platform reputed company Medical Devices domain (preference class II OR III)

Benefits

• Hybrid work (minimum 3 days onsite) in Andover, MA, or remote
• reputed company time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company reputed company holidays, Personal Days, reputed company Leave
• Medical, dental, and reputed company coverage (or provincial reputed company coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs

reputed company

Company H1B Sponsorship