Senior Development Engineer
Tyber Medical LLC
Summary
Design medical grade products that are solutions to end user needs through regular interaction with engineering, quality, sales and customers. Serve as project leader on cross functional project teams. He/she must conform to the guidelines described in the company's quality system and other policies.
Job description
Primary Job Responsibilities
- Lead cross functional project teams to ensure program success and technical rigor
- Interface with external and internal customers including, surgeons, suppliers and hospitals to identify and understand new opportunities
- Provide knowledge of medical materials, medical device manufacturing
- Engineer the design, development, validation and release of products
- Develop customer and product requirements for new products
- Plan, implement, monitor and deliver designated tasks and deliverables
- Lead and guide design for manufacturing approaches for new products
- Provide guidance and lead FMEA's and risk management exercises
- Provide strategy and lead the execution of Design Verification & Validation activities
- Develop and maintain an expertise level in product domain and competitive landscape
- Provide technical elements as needed to support regulatory submissions and patent applications/responses
- Direct cadaver, animal and bench studies as needed
- Participate in completing Design History File and in design review meetings
- Perform other related duties as assigned by supervisor
Secondary Job Responsibilities
- Support business development and management activities
- Participate in research assignments including trade show and other conference attendance
- Respond to field questions related to products and projects when necessary
- Assist Sales & Marketing efforts regarding technical support on products
- Work with suppliers on design reviews and design transfer
Educational Requirements
BS in engineering (ME and/or Biomedical a plus)
Requirements
- BS in engineering
- ME and/or Biomedical engineering degree a plus
- Experience in medical device manufacturing
- Experience with risk management and FMEA
- Experience with design verification and validation
- Experience leading cross-functional project teams
- Knowledge of medical materials
- Experience with regulatory submissions
- Experience with Design History File
Company overview
Tyber Medical LLC is a leading orthopedic device manufacturer specializing in providing rapid access to FDA-cleared and CE-marked private label orthopedic implants for the spinal, extremity, and trauma markets. Founded in 2012 and headquartered in Bethlehem, Pennsylvania, the company has established itself as an innovative Original Equipment Manufacturer (OEM) that designs, verifies, and validates full Class II orthopedic systems using QSR and ISO 13485 certified quality systems. Tyber Medical's core business model focuses on enabling orthopedic companies, stocking distributors, hospitals, and GPOs to quickly expand their portfolios with regulatory-approved implants through private labeling arrangements. The company has developed proprietary technologies including TyPEEK™ (titanium plasma sprayed PEEK) osteoconductive coatings and BioTy™ antimicrobial nano-textured surface modifications. Since its inception, Tyber Medical has successfully released more than 50 spine, extremity, and trauma systems, averaging just 12 months from signing to global launch. The company's differentiated bioengineered technologies and rapid commercialization capabilities have positioned it as a strategic partner for medical device OEMs seeking to accelerate time-to-market while maintaining rigorous quality and regulatory standards.