About the position
This position is responsible for leading the technical aspects of design and development of new medical device/equipment products from initial concept stage through to release and includes evaluating designs through modeling and testing. This position will be managing the work of 3rd party design and development partners. This position acts as a senior collaborator, participating in and contributing to the development of project requirements, technical studies, investigations and designs in support of assigned projects. Manages work activities for systems (software, electrical, mechanical and disposable) portions of the capital equipment projects. This position is also responsible for managing sustaining activities and authoring and executing system V&V protocols.
Responsibilities
- Develops new technology, products, materials, processes, or equipment with minimal supervision.
- Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects.
- Assist production personnel on assigned project.
- Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
- Innovate, design, develop, optimize and implement processes, procedures, tooling and equipment for new products with specific emphasis on design for manufacturability.
- Consistently generates innovative and unique solutions to market needs and submits idea disclosures.
- Assist in the development of less experienced staff.
- Research applicable codes and standards.
- Estimate project requirements and project schedules.
- Establish system level design concepts for Medical Capital Equipment.
- Prepare project specifications.
- Produce associated Requirement Specification and Verification and Validation documentation.
- Draft system architecture and design documentation.
- Investigate, identify and resolve technical problems and establish procedures and corrective actions to avoid recurrences.
- Perform engineering duties that require exercise of judgment and application of standard engineering principles and practices.
- Work from instructions, drawings, proposals, specifications, and other important information.
- Establish formats and instructions.
- Determine operational feasibility by evaluating analysis, problem definition, requirements, solution development, and proposed solutions.
- Improve operations by conducting systems analysis; recommending changes in policies and procedures.
- Update job knowledge by studying state-of-the-art development tools, hardware requirements, participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
- May perform other duties as assigned.
Requirements
- Bachelor's Level of Degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or similar Engineering field of study.
- 8 years of demonstrated experience in medical capital equipment and disposable device product development.
Nice-to-haves
- 5+ years of medical device experience.
Benefits
- Some travel up to 20% of the time.
