Staff Engineer, Biomedical Engineer

Job Title

Staff Engineer

Location:

Covington, GA
Duration: 6+ Months Contract
Client:
Medical Device Company

Employment Type:

Contract on W2 (US Citizen or GC Holder only)
Business Unit: BD Urology and Critical Care (UCC) – Research & Development group

The BD Urology and Critical Care (UCC) business unit is seeking a Staff Engineer for the Research and Development group. The position is responsible for the design and development of innovative products within the Home Care Platform, a high‑growth platform in UCC. The role will partner with Platform Marketing teams to interface with cross‑functional internal and external experts, key opinion leaders, and customers to gather feedback, identify, assess, and build support for innovation business cases that expand the Home Care portfolio and deliver new solutions to customers and patients worldwide.

Provides technical leadership for New Product Development projects. The ideal candidate will have experience working with Class 1, 2, or 3 electro‑mechanical medical devices.

• Provides technical leadership for New Product Development projects
• Directly responsible for leading urgent and/or important projects from planning and administration through all development, laboratory test, clinical evaluation, and market preference test
• Invent/innovate prototype devices utilizing innovative material and process technologies to achieve concept objectives; conduct design reviews and perform failure mode and effects analysis
• Work independently applying comprehensive and diverse engineering principles and practices to broad assignments, possibly including independently leading a moderate project, under the direction of Technical Management
• Review new product concepts; and in conjunction with a product development team, develop performance specifications and project schedules
• Create 3‑D CAD databases
• Closely follow established design control procedures and documentation practices
• Assist in ensuring the Quality System Requirement (QSR) compliance of the design control process in product development
• Develop laboratory tests, protocols and reports to assure conformance of prototype devices to performance specifications, FDA and applicable international regulatory and biocompatibility requirements
• Interface with internal and external engineering groups for the fabrication of devices to support both animal and human clinical evaluation
• Evaluate device performance through animal and/or human clinical investigation; and, as required, implement appropriate product changes to include revision of performance specifications
• Transfer new products/systems to manufacturing
• Interface with vendors, consultants, and customers; provide guidance on the development of supply agreements as required
• Provide technical direction to manufacturing during pilot production, as well as on currently manufactured products
• Communicate project status, through verbal and written reports and schedules, to management

• Proven experience in technology or innovative product development preferably in the medical device industry with successful track record of commercializing Class 1, 2, 3 devices
• Experience in Urology, Surgical, Wound Care preferred
• Proven ability to interface with various levels of the organization
• Solid understanding of industry regulations as it pertains to medical devices, external standards, design controls, quality controls, manufacturing methods
• Track record of development and commercialization of medical devices, generating and documenting intellectual property, an in‑depth or creative approach to problem solving, contributing to development of new concepts, providing technical guidance on design theories and applications
• Capable of prioritizing tasks and providing a timely schedule of completion
• Capable of detailed component and sub‑assembly level analysis (not limited to tolerance or finite element analysis)
• Capable of performing complex analysis independently
• Demonstrated proficiency in communicating best practices
• Protocol/report testing and writing (Verification and Validation)
• Test method validation
• Human Factors Engineering (Formative…