Novozen Healthcare LLC · 6 hours ago
Control Design Engineer
Ohio, United States
Contract
Onsite
Senior LevelNovozen Healthcare LLC is seeking an experienced Design Control Engineer to support R&D programs through hands-on ownership of design control activities across the product lifecycle. The role involves leading design control activities, developing verification strategies, and ensuring compliance with internal and regulatory requirements.
BlockchainHealth CareInformation TechnologyIT InfrastructurePenetration TestingSoftwareStaffing AgencyWeb Development
Hiring Manager
TARUN KUMAR
Responsibilities
Lead and support design control activities within R&D programs to ensure products are developed, verified, and documented in accordance with internal and regulatory requirements
Independently review design inputs, requirements, and drafted documentation to identify gaps and improvement opportunities
Develop, author, and execute design verification testing protocols
Analyze and interpret test data, including pass/fail results across large product populations (e.g., 500+ units)
Prepare and author design verification reports and technical summaries
Perform CAD drawing updates and manage revisions through PLM systems
Ensure accurate linkage between requirements, test protocols, drawings, and reports within PLM
Contribute to cross-functional R&D efforts to ensure design control activities are properly developed and executed
Support product development phases by balancing testing, documentation, and design updates as project needs evolve
Provide technical leadership and ownership rather than relying on prescriptive task direction
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Biomedical, or related field)
Strong experience with CAD drawings and PLM systems
Proven background in Design Control within R&D environments
Experience authoring technical documentation independently (protocols, reports, design records)
Hands-on experience with design verification testing
Ability to analyze large volumes of test data and clearly document conclusions
Demonstrated ability to work independently and take ownership of tasks
Experience in lead roles or titles within engineering or design control functions
Preferred
Experience in regulated industries (medical device, life sciences, or similar)
Familiarity with design control standards (FDA, ISO 13485, etc.)
Prior involvement in end-to-end product development lifecycle
Strong cross-functional collaboration skills with R&D, engineering, and testing teams
Company
Novozen Healthcare LLC
At Novozen Healthcare, we excel in bridging the gap between academics and industry.
Founded in 2018
201-500 employees
H1B Sponsorship
Novozen Healthcare LLC 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 (47)
2024 (34)
2023 (20)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Vijay Kumar
Sr. Recruitment Partner
Company data provided by crunchbase