Device Development Engineer II, Drug Delivery Device

Company DescriptionKatalyst 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 partners.Job DescriptionJob Description: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.Requirements:• More than 5 years’ experience in the field of medical device or combination product development and commercialization is required.• A Bachelor’s of Science Degree in Engineering required, a Master’s of Science Degree preferred.• Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820) and ISO14791 requirements.• Proven track record of developing and gain regulatory approval of drug delivery systems a plus• Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc..).• 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 desirable.• 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 applications.• Effective planning and organizational skills.• Excellent writing and oral communication skills.• Strong collaboration skills with internal and external partners.Additional InformationAll your information will be kept confidential according to EEO guidelines.