Alphatec Spine · 2 days ago
Senior Design Engineer, Biologics
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Health CareMedical Device
Insider Connection @Alphatec Spine
Responsibilities
Designs and develops biologics products from concept to full launch
Leads the development of new products and manufacturing processes and/or serves as a member of a project team
Directs the development of working prototype models to be used for project design evaluation
Manage designers or coops
Generates protocols for testing and analyzing new and current products
Generates design assurance documentation for the project Design History File (DHF)
Develops quality control procedures and inspection methods
Initiates design changes relative to manufacturability while maintaining critical features of each product for in house manufacturing or vendors
Leads and/or serves on cross-functional product development teams responsible for new product development from concept through product launch
Provides technical input to marketing counterparts on the development of collateral marketing materials
Provides technical expertise to marketing and sales as to intent of design function
Provides technical experience to Regulatory Affairs to support FDA 510K submissions
Creates and processes Engineering Change Orders (ECO's)
Other duties as assigned
Qualification
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Required
Experience with phase gate design control processes
Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics
Knowledge in the use and interpretation of geometric dimensioning and tolerancing
Strong verbal and written communication skills; comfortable presenting to senior management
Undergraduate degree in biomedical engineering, with an emphasis in biomaterials
3-5 years of product development experience, preferably in spine or implantable orthopedic medical devices
Preferred
Experience with 3D CAD system, preferably Solidworks
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable)
Company
Alphatec Spine
Alphatec Spine is a medical device company developing products and treatments for spine disorders.
H1B Sponsorship
Alphatec Spine 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
Trends of Total Sponsorships
2023 (4)
2022 (2)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$671.95MKey Investors
Squadron Medical Finance Solutions
2023-10-24Post Ipo Equity· $150M
2023-04-19Post Ipo Equity· $60M
2023-01-06Post Ipo Debt· $150M
Recent News
Business Wire
2024-06-05
2024-06-05
2024-06-05
Company data provided by crunchbase