Infotree Global Solutions · 1 day ago
Medical Device Engineer
Thousand Oaks, CA
Contract
Onsite
Mid LevelInfotree Global Solutions is seeking a Medical Device Engineer to participate in the design, development, and lifecycle management of drug delivery devices. The role involves technical operations support for product development, manufacturing, and continuous improvement initiatives, requiring collaboration with cross-functional teams and adherence to strict documentation practices.
Human ResourcesStaffing AgencyTechnical Support
Hiring Manager
Chandan Sharma
Responsibilities
Adheres to strict documentation practices in a GMP regulated environment
Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems
Authors and reviews technical documentation including protocols, reports, and technical assessments
Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
Maintains device and combination product design history files for assigned products
Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
Provide general laboratory support including inventory management, sample shipments, and cleanup
Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
Qualification
Required
Hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab)
Good Communication and Technical Writing Skills
Statistical Analysis
Adheres to strict documentation practices in a GMP regulated environment
Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems
Authors and reviews technical documentation including protocols, reports, and technical assessments
Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
Maintains device and combination product design history files for assigned products
Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
Provide general laboratory support including inventory management, sample shipments, and cleanup
Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
Preferred
Bachelor's Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
Understanding of Mechanical Design Engineering Concepts
Experience with Final Drug Product and/or Drug Product, medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
Experience with design controls; including (but not limited to) design verification and transfer
Understanding of risk assessments including hazard and probability analysis
Experience with investigations and quality records
Laboratory and electronic lab notebook experience
Statistical Analysis software (Minitab or JMP)
Experience with Instron force testers using BlueHill Universal
Test method development, GR&R, and text fixture design
Ability to work independently and dynamically across functional teams
Strong technical writing and verbal communication skills including technical presentations (i.e., PowerPoint)
Ability to support complex workstreams under demanding timeline
Understanding of the following standards and regulations: Quality System Regulation – 21CFR820; Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices – ISO 14971; EU Medical
Company
Infotree Global Solutions
Infotree Global Solutions is a talent management company specializing in staffing and payroll solutions.
Founded in 2002
1001-5000 employees
H1B Sponsorship
Infotree Global Solutions 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 (8)
2024 (9)
2023 (11)
2022 (17)
2021 (16)
2020 (19)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Kingswood Capital Management
2025-02-20Private Equity
Leadership Team
Matt Milano
Chief Executive Officer
Klaus Geiser
Chief Financial Officer
Recent News
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