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Scientific. Clinical. Software Engineering

Engineering Support Specialist

Bethesda Metro Area, MD

Job Type: Scientific Job Number: JN -042020-26764 Region: Bethesda Metro Area

Job Description

Candidate will:

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

Position Requirements:

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.

Educational Requirement:

BS, MS, or PhD degree in Mechanical/Electrical/Biomedical/Chemical Engineering, Physics, Pharmaceutical Sciences, or related field.

Experience Requirement:

PhD 0-3 years, MS 2-5 years, and BS 5-7 years of relevant experience.

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