Intellectt Inc · 2 days ago
Senior Firmware – Design Engineer (NPD Focus)
Beverly, MA
Contract
Onsite
Senior Level, Lead/Staff
9+ years expIntellectt Inc is seeking a Senior Firmware Design Engineer to support a next-generation medical device console program. This role involves driving design quality early in the New Product Development lifecycle and ensuring compliance with medical device regulations and standards.
Information TechnologyRecruitingStaffing Agency
Responsibilities
Support early-phase NPD activities including design quality planning and execution
Drive compliant design changes through the CCB (Change Control Board) process
Ensure documentation and updates meet 21 CFR Part 11, 524B, and IEC 62304
Participate in Agile sprint cycles, daily SCRUM, and sprint planning
Support risk management activities (per ISO 14971)
Perform software code reviews and design reviews
Support cybersecurity risk assessments and cyber risk-related activities
Qualification
Required
9-10+ years of experience (Senior level required)
Strong experience supporting both Firmware + system-level software (EPC)
New Product Development (NPD) experience in medical devices
Medical Device Software Quality + Standards knowledge: ISO 14971, IEC 62304, ISO 13485
Understanding of design inputs and requirement development
Experience with SiMD/SaMD
Tools: JAMA + JIRA
Agile/SCRUM experience
Solid understanding of cybersecurity principles in medical device development
Company
Intellectt Inc
Intellectt Inc.
1001-5000 employees
H1B Sponsorship
Intellectt Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (271)
2024 (255)
2023 (312)
2022 (372)
2021 (217)
2020 (134)
Funding
Current Stage
Late StageCompany data provided by crunchbase