*** NEW REQUIREMENT *** CONCEPT DEVELOPMENT ENGINEER FOR HOME DELIVERY AND SELF - ADMINISTERED DRUG SYSTEMS REQUIREMENT #13-00450 RECRUITER: KAREN GULUTZ JOB LOCATION: NEW BRUNSWICK, NJ SEPTEMBER 17, 2013 Project Description: Partner with commercial team to define the delivery device strategy for early pipeline products as well as establish effective commercialization materials for late stage combination products. Responsibilities: • Responsibilities include designing market research / HFE studies to define and test patient needs and preferences, manage vendor relationships to evaluate device technologies, negotiate contracts and lead device feasibility work, as well as collaborate with cross - functional team members to define requirements and ensure alignment with program goals • Identify new technologies for drug delivery and leverage understanding of first engineering principles, customer needs, and technical judgment to assess device platforms against internal and external needs, with emphasis on safety, efficacy, user convenience, design robustness, and manufacturability • Maintain an overview of state - of - the art technology development within drug delivery by identifying trends in clinical practice and regulatory landscape, evaluating and benchmarking competitive products, processes or new trends which may impact the Company’s business. Develop and maintain a network of professionals / experts to advance Company goals and be at the forefront of technology development and innovation. • Use of quantitative and qualitative means to design effective market research studies • Lead efforts to determine appropriate type and scale of research as well as study design (questionnaire, demographics, etc.) to accurately capture the voice of the customer. Use of statistical tools to analyze the results to enable actionable recommendations. • Support the device development process by establishing and validating user requirements, translation into product / engineering specifications, formative and summative studies, design reviews, risk assessments, post - market assessment activities and development of commercialization materials • Ensure all development activities are executed in alignment with design controls, with the proper documentation for traceability Requirements: • Bachelor’s degree in mechanical, or industrial, engineering • Minimum of 5+ years of related work experience (in the medical device, pharmaceutical or biotechnology industry). • Understanding of disciplined product development process, including design controls and regulatory submission process • Experience with front – end product development for Home Delivery Systems (auto injectors, patch pumps, reconstitution systems, etc.) and Self – Administered Drug Systems (hypodermic, surgical tools, implantables, etc.) would be ideal • Detail - oriented, self - motivated with an aptitude for analytical problem-solving • Excellent written and verbal communication skills • Strong technical skills and familiarity with competitive landscape, industry trends, human factors and regulatory environment for combination products Required Skills: Bachelor’s degree in mechanical, or industrial, engineering; Experience with front – end product development for Home Delivery Systems This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Karen: karen@alphaconsulting
Posted on: Tue, 17 Sep 2013 18:40:17 +0000
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