The Urology and Critical Care (UCC) division 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 Endourology group. Responsibilities will include activities starting at design planning and continue through verification, validation and design transfer. The ideal candidate will have experience working with endoscopic equipment and devices. This position is with a Medical Device company, experience working in a regulated industry is needed; knowledge of FDA and applicable international standards and regulations are preferred.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Invent/Innovate prototype devices utilizing innovative material and process technologies to achieve concept objectives. Conduct design reviews and perform failure mode and effects analysis.
- Be able to 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 specification and project schedules.
- Creation of 3-D CAD databases.
- Closely follow established design control procedures and documentation practices.
- Assist in ensuring the Quality System Requirement (QSR) compliance of 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.
- Engineering knowledge at level normally attained through an advanced degree program.
- Proven ability to interface with various levels of the organization.
- Understanding of various manufacturing methods. Examples include injection molding, extrusion, stamping/forming, machining, welding and bonding.
- Requires solid understanding of:
- Industry regulations as it pertains to medical devices
- External Standards, Design controls, Quality controls, Manufacturing methods
- Requires track record of:
- Development and commercialization of medical devices
- Generating and documenting intellectual property
- In depth or creative approach to problem solving
- Contributes to development of new concepts
- Technical guidance on design theories and applications
- Capable of prioritizing tasks and provide 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 proficiencies of communicating best practices
- Protocol/report testing and writing
EDUCATION and/or EXPERIENCE:
- 8+ years of experience as a design / development engineer.
- BS degree in Mechanical Engineering.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!
This position does NOT provide sponsorship so please do NOT apply if you require sponsorship. Thank You
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