Intellectt Inc · 3 hours ago
Design Quality Engineer – 510(k) & DHF Focus
Pennsylvania, United States
Contract
Onsite
Mid LevelIntellectt Inc is looking for a Design Quality Engineer to provide bandwidth support for an upcoming 510(k) submission for a medical device. The role focuses on executing and documenting the formal Product Development Process, particularly in regards to Design History File ownership and support.
Information TechnologyRecruitingStaffing Agency
Hiring Manager
Uday Katari
Responsibilities
Support 510(k) submission activities for an existing medical device
Own or contribute significantly to Design History File (DHF) documentation
Execute design controls within a formal PDP environment
Develop and maintain:
DFMEA / FMEA
Design packages
Prints, specifications, and technical documentation
Support ECO / ECR activities
Contribute to verification strategy (understanding test methods; execution not required)
Ensure compliance with FDA design control requirements
Qualification
Required
Strong experience with DHF documentation
Hands-on work with DFMEA / FMEA
510(k) submission support experience
Experience in a formal PDP / design control environment
Familiarity with Engineering Change Orders (ECOs/ECRs)
Familiarity with GD&T (Geometric Dimensioning & Tolerancing)
Familiarity with technical drawings and specifications
Experience with Class I medical devices
Company
Intellectt Inc
Intellectt Inc.
Founded in 2018
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
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2025 (271)
2024 (255)
2023 (312)
2022 (372)
2021 (217)
2020 (134)
Funding
Current Stage
Late StageCompany data provided by crunchbase