Design Controls Engineer jobs in United States
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Katalyst CRO · 2 months ago

Design Controls Engineer

positionAvenel, NJ
timeContract
remoteOnsite
senioritySenior Level
date5+ years exp

Katalyst Healthcares & Life Sciences is a leading medical device organization seeking an experienced Human Factors Design Controls Engineer. This role involves collaborating with cross-functional teams to support usability engineering, design controls, and risk management activities for innovative medical technologies.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Support usability engineering documentation and design controls
Remediate and improve risk analysis documentation per ISO 14971 & IEC 62366
Work cross-functionally with HF, Quality, Regulatory, Engineering & Clinical teams
Manage requirements, traceability & compliance using tools like Polariton, Agile, Smart sheets
Create structured usability deliverables for regulatory submissions

Qualification

Human FactorsDesign ControlsRisk ManagementISO 13485FDA Design ControlsISO 14971IEC 62366Medical device developmentCollaboration toolsDocumentation tools

Required

5+ years in Human Factors / Design Controls / Risk Management
Medical device development experience required
Strong knowledge of ISO 13485, FDA Design Controls, ISO 14971, IEC 62366
Proficient with collaboration & documentation tools (Polariton / Agile / etc.)

Company

Katalyst CRO

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Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
location
South Plainfield, New Jersey, USA
people-size51-200 employees
web-link
http://katalysthls.com

H1B Sponsorship

Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)

Funding

Current Stage
Growth Stage

Leadership Team

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John Patil
Recruiter, Pharma/CRO Staffing Division
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Recent News

LinkedIn
Katalyst HealthCares & Life Sciences on LinkedIn: Candidate Portal
2024-04-07
Company data provided by crunchbase