Our client is seeking a Technical Leader to oversee and guide mechanical design efforts across multiple programs. This position requires a motivated, results-driven design engineer with expertise in development and the ability to guide cross-functional teams to accomplish objectives.
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About Ventura Solutions
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Ventura Solutions provides End-to-End consulting, staffing, and training services for the Medical Device and Combination Products industry.
We provide consulting, staffing, and training solutions in the following areas:
-Design Controls
-Risk Management
-Verification & Validation
-Design and Development
-Project Management
-Quality
-Regulatory
-Human Factors
-DHF & Quality System Remediation
-Software as a Medical Device (SaMD)
-Statistics
-Clinical Affairs
-Market Access
-Funding
-NIH SBIR Grants
-Start-Ups
Ventura Solutions is your one-stop shop for getting your product to the market or keeping it compliant.
Detailed list of areas of expertise:
Medical Device & Combination Product Consulting
Design Controls, Risk Management, 21 CFR 820.30, ISO 13485, ISO 14971, Design and Development, Systems Engineering, Project Management, Quality Assurance, Human Factors, IEC 62366, Usability, Design Verification, Design Validation, Statistics, Design History File (DHF) Remediation, Software as a Medical Device (SaMD), Manufacturing, Change Control, Regulatory, FDA Q-Sub, Pre-Sub, Breakthrough Device Program (BDP), Investigational Device Exemption (IDE), 510(k), MDR
Medical Device Start-Up & Business Consulting
Co-Development Deals, Licensing Deals, Fundraising, Non-Dilutive Funding, NIH SBIR Funding, Mergers and Acquisitions (M&A), Commercialization, Valuations, Equity Distributions, Board of Directors, Leadership, Organizational Development, Building High Performing Teams, Concept Evaluation & Selection, FDA or EU Regulatory Strategy, Value Proposition
Staffing, Direct Placement, & Executive Recruitment
Medical Device Engineers, Risk Management Engineers, Systems Engineers, Human Factors Engineers, Design Verification & Validation Engineers; Test Method Development Engineers, Materials Engineers, Project Managers; Process Validation Engineers, Process Development Engineers, Quality Engineers, Design Assurance Engineers, Regulatory Affairs Specialists
