Sr Clinical Engineer
6 Tech Drive Greater Boston area, Massachusetts
Position Title: Sr Clinical Engineer
Job Location: Greater Boston area
Interview Expectations: onsite
Local Candidate: yes
Required Skill Sets: clinical background, engineering
Contribute in a role central to the definition, development and validation of multi-parameter patient monitors and system solutions. Serves as clinical application domain expert that 1) works with clinical end users to evaluate user requirements, and software and hardware prototypes to gain understanding on clinical needs and workflows of various care environments and 2) delivers the clinical context to development teams and other disciplines. Responsible for managing and executing clinical evaluations and any clinical trials. Solve a wide range of issues including analyzing field issues, reliability problems and standards changes. Coordinate closely with many other disciplines including Risk Managers, Product Management, Engineering, Post Market Surveillance, Product Qualification, Quality and Regulatory.
- Participate on the Requirements Specification Team in the development of the Customer Requirements and Technical Systems/Sub-system Requirements Documents.
- Support the development of a Product or Systems Concept Document as part of the Product Concept team. Support and critique the User Interface Design.
- Establish and maintain contact with clinical experts for understanding of clinical needs, product opportunities, and technology direction.
- The Clinical Engineer supports formative and summative usability testing of their products in alignment with the Human Factors process and in conformance with current standards (e.g. ISO/IEC 62366, ISO 14971, ANSI/AAMI HE75). Works closely with the Human Factors Engineer, Risk Manager, User Interface designer and Product Manager throughout usability evaluation process.
- Responsible for managing Alpha/Clinical testing, prepare test protocols, gather clinical data, perform data analysis and to generate any necessary reports. Travel expected.
- Responsibility to understand how the product will be used and convey clinical context to the development teams throughout concept, definition, and implementation phases.
- Participates in the safety hazard/risk analysis on products/systems, collaborating with the risk manager and other engineering disciplines in accordance with internal processes and standards (e.g., ISO 14971), including usability hazards that may result due to normal use, reasonably foreseeable misuse, or abnormal use.
- Member of cross functional team responsible for planning and executing project deliverables according to the project plan and supporting other disciplines as needed.
- Performs other duties as needed and assigned.
Education: Biomedical/Clinical Engineering (other related Clinical or Engineering Education will be considered) B.S or the equivalent in education, training and experience; Master’ s degree preferred.
- Minimum of 5 years related experience in clinical research, medical device industry or equivalent; one to two years with a MS.
- Experience as a hospital-based Biomedical/Clinical Engineer or as a clinician is a plus
- Prior experience with statistical analysis is also a plus.
Special Competencies or Certifications:
Knowledge of FDA regulations related to clinical data, clinical studies and product submissions is a benefit. First hand hospital knowledge is desired.