Intellectt Inc · 2 days ago
Senior Research And Development Engineer
California, United States
Contract
Onsite
Mid, Senior Level
3+ years expIntellectt Inc is seeking a Senior R&D Engineer with strong experience in medical device manufacturing and design assurance/quality engineering to support late-stage product development and commercialization activities. The role involves collaborating with various teams and ensuring compliance with regulatory requirements.
Information TechnologyRecruitingStaffing Agency
Hiring Manager
Daya Songa
Responsibilities
Support late-stage design, manufacturing readiness, and commercialization activities for medical devices
Collaborate closely with Manufacturing, R&D, and Quality teams to execute and support process qualification (IQ, OQ, PQ)
Identify, troubleshoot, and resolve manufacturing and quality issues on the production floor
Develop and finalize qualification strategies, inspection methods, and acceptance criteria in partnership with Quality Control
Support risk management activities, including FMEA and other design and process risk assessments
Provide engineering support for early-phase NPD projects, including early human use (EHU) activities when required
Balance desk-based engineering work with hands-on manufacturing floor and cleanroom support
Ensure compliance with applicable regulatory and quality system requirements
Qualification
Required
Bachelor's degree in Engineering or a related technical discipline (or equivalent relevant experience)
Minimum of 3 years of experience in medical device engineering; senior-level profiles preferred (5–10 years ideal)
Hands-on experience with Class III medical device manufacturing
Strong background in Design Assurance and/or Quality Engineering
Proven experience executing and supporting IQ, OQ, and PQ activities
Solid understanding of New Product Development (NPD) phases (Phase 1–5)
Experience supporting process qualification and manufacturing readiness in regulated environments
Preferred
Manufacturing engineering background
Exposure to early-phase NPD or Early Human Use (EHU) projects
Cleanroom manufacturing experience
Experience using statistical tools such as Minitab
Experience working with polymers and/or medical device sheaths
Company
Intellectt Inc
We advance technology with purpose - empowering enterprises move confidently into the future.
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