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PRODUCT DEVELOPMENT ENGINEER - 020118

Job Description

Product Development Engineer designs and develops new implants and instrumentation systems. Directly communicates with surgeons, sales consultants, and product managers to understand clinical issues. Defines design parameters, and ensures by design the correct product is provided to meet customer requirements. Independently completes device and instrument designs. Responsible for initiation and completion of development projects on time and within budget.

Essential Job Functions

  • Applies engineering knowledge and project management skills to the design and development of new products as well as product changes and enhancements to existing devices in our product portfolio.
  • Plans, schedules, conducts, or coordinates detailed phases as part of a major project.
  • Prepares CAD models and detailed drawings of instruments, implants and prototypes.
  • Reviews, initiates or approves engineering drawings, layouts, change orders and specifications.
  • Exhibits strong written and verbal communication skills and interfaces effectively with surgeons.
  • Solves mechanical engineering problems at the component through system level. Conducts testing utilizing existing test protocols or develops new ones as needed.
  • Responsible for reliability and manufacturability of products or technologies developed.
  • Prepares all necessary paperwork and documentation for the DHF.
  • Oversees outside vendors and consultants as required. Provides mechanical engineering support in the resolution of product complaints and/or safety issues.
  • Responsible for compliance with QSR, international compliance standards, and company procedures.


Skills

  • Proficient in Solid Works software or other similar 3-D CAD program.
  • Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel.
  • Self-directed with ability to work with minimal supervision.
  • Strong task prioritization and time management skills.
  • Working knowledge of applicable regulations and/or experience working in a regulated environment.
  • Logical and proactive approach to problem solving.
  • Effective cross-functional project management skills.
  • Demonstrated experience with all phases of the Design Control process of FDA and ISO 13485 regulations and understanding of disciplined product development processes, regulatory and quality requirements for medical products.


Position Qualifications

  • BSME or equivalent degree
  • 3 to 5 years of experience in orthopedic development (hip/knee product development a plus)

 

To apply, send resume and cover letter to careers@theken.us. Please reference the job title in your email subject line.


careers@theken.us