MVP Candidates
We search and build relationships with candidates. Our firm recognize the superstar professionals that will add value to your company and help enhance the market growth of your medical devices. Let us know if you would like to explore an MVP candidate further.
J.T: Product Development Engineer
Experienced product development engineer with a focus in the medical device market. Proven project management skills to take an idea from concept to market in a professional, detailed, and efficient manner. Handled all aspects of product lifecycle successfully within cross-functional teams and through intercompany collaboration.
Specialties: New Product Development; Concept Design, Prototyping, FEA and DFM, Design History File (DHF) and Device Master Record (DMR) management
Experience in FDA and ISO design control guidelines and Project Management
T.W: Regulatory Affairs Manager
A seasoned engineering professional with extensive multidisciplinary experience surrounding the development and manufacture of state-of-the-art radio telecommunications equipment. This experience spans test systems engineering, quality assurance/systems, and regulatory affairsrelated to this industry. With experience both as an individual contributor and a technical manager, applies an incisive yet sensitive, consultative approach to meeting/exceeding customer expectations and resolving their concerns.
Specialties: Proven ability to manage complex projects; Builds and maintains effective teams; Broad experience, including New Product Development; Software, Manufacturing, and Design Verification; Deep experience in international regulatory affairs; Extensive Quality Assurance background; Well versed in statistical/analytical methods; Works effectively with a diverse array of people, from the factory floor to the executive suite; and Highly customer focused.
K.L: Quality Assurance Engineer
Motivated professional with a record of successfully supporting, developing, validating, and introducing into operations medical devices for commercialization into global markets. Research andDevelopment leader with proven ability to align cross-functional teams in product development, operations, quality assurance and marketing to support global product launches. Multi-discipline professional with over ten years of experience strengthening product development competencies in New Product Development, Quality Assurance, and Operations.
Specialties:Product Development and Design Controls; Design Validation and Verification; FDA Premarket Approval and CE Mark Submissions; Black Belt in DMAIC – Statistical Analysis; Product Design for Manufacture; Design Transfer to Manufacturing; Device Platforms: PTA, PTCA, SDS, SES, VCD; Drug Combination Devices; Intellectual Property Management; Project Management Tools; and FDA and BSI Audits