Our client seeks a highly motivated individual who will assist in the research and development of a cancer diagnostic system. Position level and salary will be commensurate with experience and training.
The successful candidate will:
Develop and implement our proprietary platform including the development of procedures for testing performance, acceptance/rejection criteria and conformity;
Train and provide technical engineering support to SnapPath end users;
Collaborate with custom product vendors, expert contractors and outside engineering teams to improve platform performance and reliability;
Plan and conduct hands-on experimental work (in vitro and ex vivo) to fully evaluate instrument prototypes, demonstrate clinical feasibility, and make improvements to the instrument;
Apply statistical methods to design appropriate experiments and determine confidence in experimental results; and
Travel throughout the US, periodically.
There is no relocation compensation provided.
BS or MS degree in Biomedical Engineering.
3-5 years’ experience in medical device or diagnostics, preferably in oncology or with cancer-related products in regulated environments.
Background and Skills:
Experience with automated liquid handling specialist preferred, ideally with Perkin Elmer Janus or Tecan systems;
Working knowledge of xml and script writing;
Familiarity with a range of biological/analytical assays for the purposes of application development and validation;
Knowledge of safe handling and disposal of chemicals and biohazardous waste;
Willingness to work with fresh human is mandatory;
Willingness to work with animal tissues is preferred;
Ability to maintain a well-organized laboratory notebook and document findings in well written reports.
Knowledge of FDA requirements and regulatory standards in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes, risk analysis, the Design History File (DHF) and related records;
Effective written and verbal communication skills;
Experience in project management with particular emphasis on the ability to manage and prioritize tasks
Excellent problem solving and analytical skills;
Strong interpersonal skills;
Motivated to work in an early-stage commercial setting geared toward product development; and
Proven ability to meet deadlines and work under aggressive timelines.