Device Functionality and Safety Engineer
Baltimore Metro Area, MD
Design and Develop device test methods and method qualification protocols.
Execute test method qualification and feasibility testing.
Author design verification plans and protocols. Coordinate with external testing labs to ensure timely completion of testing.
Execute design verification testing and author testing reports.
Support feasibility and investigation testing and studies.
Support new critical equipment installation and validation work.
Needs to be onsite in Gaithersburg.
Potential to go perm if a good fit and if there is head count at the time
Requires understanding and experience of the principles and concepts within the area of device development in the pharmaceutical industry and is expected to demonstrate up to date technical knowledge.
Knowledge of relevant compliance systems and experienced in authoring relevant sections in regulatory submissions (IND, IMPD, BLA, MAA etc.).
Prior experience with electro-mechanical drug delivery and/or medical device system development a plus.
BS, MS, or PhD degree in Mechanical/Electrical/Biomedical/Chemical Engineering, Physics, Pharmaceutical Sciences, or related field.
PhD 0-3 years, MS 2-5 years, and BS 5-7 years of relevant experience.
Good communication skills and strong interpersonal skills are essential. Demonstrated leadership capabilities, organization, flexibility, and the ability to operate in a fast-paced environment are an integral part of this position. Strong work habits and commitment to the position are highly valued. Problem solving, a hands-on scientific approach, innovation and creativity are also fundamental qualities for success in this role.
Candidate is expected to be an independent thinker and able to perform work responsibilities and determine technical objectives with minimal direction and guidance. Candidate is expected to be pro-active in identifying critical activities and prioritizing project tasks appropriately.