- Katalyst Healthcares & Life Sciences is hiring entry level
candidates for several positions for contract research in Clinical
trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug
Safety and Pharmacovigilance and Clinical Research field. We work
with University hospitals, pharmaceutical companies and recruiting
The Senior Engineer will lead technical efforts for drug
delivery device projects. As a hands-on technical leader and device
subject matter expert (SME), this person will provide project and
engineering leadership in the concept, feasibility, development,
qualification and launch phases of device development. Area of
focus will include specification development, prototyping, test
development, design verification and validation testing, risk
assessments. Extensive collaboration with cross functional partners
will be required.
More than 5 years experience in the field of medical device or
combination product development and commercialization is
A Bachelors of Science Degree in Engineering required, a Masters
of Science Degree preferred.
Experience in developing and commercializing regulated devices /
combination products under Design Control (21 CFR 820) and ISO14791
Proven track record of developing and gain regulatory approval
of drug delivery systems a plus
Knowledge of global industry standards (ex: ISO, AAMI, ANSI,
Strong hands on technical leadership skills with a track record
of delivering new products to market.
Strong communication skills (written and verbal), including
experience presenting in front of multidisciplinary audiences, is
DFSS certification is highly desirable.
Working knowledge of solid works desirable.
Key Skills and Competencies
A strong knowledge of developing and commercializing FDA
regulated devices / combination products under Design Control
regulations and ISO14971.
Extensive knowledge of engineering principles, concepts and
Effective planning and organizational skills.
Excellent writing and oral communication skills.
Strong collaboration skills with internal and external
All your information will be kept confidential according to EEO
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