Posted on February 16, 2022
THE FOLLOWING REQUIREMENTS MUST BE MET TO BE CONSIDERED FOR THIS POSITION:
- BS in electrical, mechanical, biomedical or computer science engineering w/ minimum of 8 years experience in an interdisciplinary product development environment or a masters degree in electrical, mechanical, biomedical, or computer science engineering w/ minimum of 5 years of experience in an interdisciplinary product development environment.
- Demonstrated competency in program planning, e.g. developing work breakdown structures, resource planning.
- Thorough understanding of requirements management; from user needs through verification and validation; experience with requirements management tools.
- Working knowledge of ISO 14971 and/or experience in conducting risk management activities, e.g. hazard analyses, FTA, and FMEA.
- Experience in the development of system architectures.
- Working knowledge of safety compliance process (product safety marks).
- Experience in the conduct of design verification activities.
- A minimum of 2 years of this experience in a SE role while operating under a quality system (e.g., ISO 9001, ISO 13485)
THE FOLLOWING IS DESIRED, BUT NOT REQUIRED TO BE CONSIDERED FOR THIS POSITION:
- Working knowledge of design validation, including human factors validation activities.
- Experience with medical device software in accordance with IEC 62304 and FDA guidance.
- Experience in supporting marketed products.
- Working knowledge of device clinical trials (from the device perspective).
- Familiarity of applicable EU Medical Device Regulations, e.g., MDR, IVDR.
- Familiarity of regulatory submissions, e.g. FDA 510(k), CE Marking.
- Familiarity of available industry reference resources, e.g. AAMI, RAPS, INCOSE.
- US citizen or permanent resident.
Please contact us to apply!
CMD MedTech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.