ACL Digital ยท 2 months ago
Biomedical Principal Engineer
New Albany, OH
Contract
Onsite
Lead/Staff
10+ years expACL Digital is seeking a Principal Medical Device Engineer to lead teams in the development of drug delivery devices. The role involves creating engineering specifications, supporting verification and validation processes, and ensuring successful device development within a cross-functional organization.
Business IntelligenceCloud ComputingDevOpsHardwareInformation TechnologyInternet of ThingsMobile AppsRetail TechnologySaaSSoftware
Hiring Manager
Chiranjeevi Mittkella
Responsibilities
Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
Create and assess product requirements to determine technical coverage and proper integration different subsystems
Create and execute to project plans and schedules
Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects
Provide deep technical assistance for junior engineers
Qualification
Required
10 YOE
CANDIDATES MUST BE ABLE TO TRAVEL INTERNATIONALLY
BS in Engineering and previous experience in a medical device industry
10 years current experience with engineering processes and procedures
Led projects from development through the 510k and PMA approval process
Strong background in engineering and commercialization of electro-mechanical medical devices
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA
Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions
Experience in drug/device combination product design and development
Familiar with the following standards: Quality System Regulation ? 21CFR820, Risk Management ? ISO 14971, EU Medical Device requirements ? Council Directive 93/42/EEC, Medical Electrical Equipment ? EN 60601
Small scale device assembly experience
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Strong problem solving, risk assessment, and risk management skills
Must be capable of working on multiple projects in a deadline driven environment
Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Engineering background need apply and will be considered
Company
ACL Digital
ACL Digital is a design-led digital engineering and transformation firm.
1001-5000 employees
H1B Sponsorship
ACL Digital 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 (38)
2024 (29)
2023 (26)
2022 (33)
2021 (20)
2020 (19)
Funding
Current Stage
Late StageLeadership Team
Srikanth Raghavan
Associate Vice President
Recent News
2025-11-28
Precedence Research
2025-11-28
Company data provided by crunchbase