Job Function:
- Responsible for product development activities that encompass the design, testing, fabrication and validation of systems and devices as well as ancillary systems that may be necessary to meet company goals and objectives.
Description:
- Applies intensive and diversified knowledge of engineering principles and practices to the research, development, design and evaluation of technical suitability of materials, components, assemblies, processes and/or equipment. Clearly communicates designs and all requisite requirements to support personnel both verbally and in writing.
- Works to improve and expand company's capabilities to provide R&D services
- Contributes to, develops and/or performs marketing and engineering specifications, feasibility plans/studies/reports, cost estimation/analysis, design reviews, risk and hazard analyses, FMEAs for Design/Process/Use, product verification and validation testing.
- Builds and implements a detailed research/development work plan to fulfill company's project objectives
- Directs support personnel and coordinates their project activities.
- Develops prototypes and processes based on company's available equipment, processes and/or specifies, procures suitable equipment for development Reviews or coordinates supplier activities to support development.
- Analyzes, recommends and implements process improvements that reduce lead-time, eliminate non-valuedadded work, improve yields, and improve process capabilities.
- Manually builds prototypes in accordance with engineering instructions, drawings and specifications.
- Writes and submits intellectual property disclosures (patents).
- Attend animal studies as needed.
- Ensures appropriate communication processes are established within and across functional groups. Communicates information related to quality management system effectiveness.
- Work in accordance with quality system procedures.
- Collaborates with medical professionals to during all stages of development of prototypes/products, including market/product specification development, pre-clinical and clinical testing of prototypes/products
- Other duties as assigned.
Other Essential knowledge, skills, and abilities:
- Ability to Function as the Project Leader from the Concept Phase through Market Release of Avantec Vascular projects
- Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.
- Proficiency with SolidWorks/CAD, word processing, spreadsheet, project management software applications.
- Ability to attend human clinical cases and interact with the hospital staff in a constructive and professional manner.
- Knowledge of vascular interventional medical products and technologies, especially catheters, vascular access devices and guide wires.
- Knowledge of medical device industry regulatory requirements including design and control practices, GMP’s and GLP’s.
- Strong analytical and communications skills.
- Out-of-the-box thinking, creativity and drive for excellence.
Training and Experience Required:
- 5+ years medical design experience in medical device/clinical environment.
- 2-3 years of team lead or supervisor experience
Education:
- BS degree in Biomedical, Mechanical, or Biomedical Science or related degree. Under certain circumstances, and at Management’s discretion, specific training and/or experience may fulfill the requirements of this position.
WORKING ENVIRONMENT:
- Job duties are primarily performed in an office environment utilizing standard office equipment such as a computer, photocopier, and telephone. The noise level in the work environment is usually low to moderate.
- May require some job duties to be performed in a laboratory environment that requires special clothing and practices and requires strict adherence to departmental and standard operating procedures. Occasionally requires some job duties to be performed at animal and human cadaver studies as well as live human cases.