Novozen Healthcare LLC · 4 weeks ago
Systems Engineer
United States
Contract
Remote
Senior Level
$45/hr - $50/hr
5+ years expNovozen Healthcare LLC is seeking a Systems Engineer with expertise in Design Controls for medical devices. The role involves supporting product development activities in a regulated environment, collaborating with Engineering, Quality, and Regulatory teams.
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No H1B
Hiring Manager
Harika Gompa
Responsibilities
Support Design Controls activities for medical device products
Maintain trace matrices and DHF documents
Coordinate V&V activities and documentation
Work with cross-functional teams including Quality, Regulatory, and Engineering
Prepare protocols, reports, and technical documentation
Support compliance and remediation initiatives
Qualification
Required
Experience with Design Controls and DHF documentation
Strong knowledge of traceability from User Needs → Design Inputs → V&V
Experience supporting Design Verification & Validation activities
Knowledge of FDA 21 CFR Part 820 and ISO 13485
Experience working in medical device or regulated industry
Strong documentation and communication skills
Preferred
ISO 14971 risk management experience
Experience with remediation/compliance projects
Familiarity with traceability and requirements management tools
Benefits
This is a contract position and does not include employer-provided benefits.
Company
Novozen Healthcare LLC
At Novozen Healthcare, we excel in bridging the gap between academics and industry.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Vijay Kumar
Sr. Recruitment Partner
Company data provided by crunchbase