(US-California-San Diego) Directs all aspects of hardware design and system integration in support of instrument product development. Provides technical leadership and management on hardware development programs from concept studies through production implementation. Also, provides technology input and technology selection for new product development. ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsible for the successful design of hardware modules and instrument platforms. Responsible for providing analysis and simulation of design capabilities as a means to fast track product development. Provide leadership of integrating designs with intended use through test and working with all functional disciplines. Manage and set priorities within area of functional responsibility. Responsible for the quality of staff and overall technical directions on design projects. Manage the cost budget within the functional area of responsibility. Manages interactions and relationships with appropriate strategic partners and cross-functional teams. Perform other related duties as assigned. EDUCATION and EXPERIENCE MS degree or equivalent in an engineering discipline with 10 or more years experience in leading the design and test of diagnostic instrument projects, or Ph.D. degree or equivalent in an engineering discipline with 8 years experience in leading the design and test of diagnostic instrument projects. Experience with the management and leadership of interdisciplinary projects Fundamental understanding of the Quality System Regulations and FDA submissions as necessary. Proven ability to assure quality and safety of products into commercialization. Demonstrated leadership skills and management skills. Excellent written and oral communication skills.
(US-Massachusetts) Do you have 5-10 years of industry experience in Clinical Trial Management? If so Read on…………. An opportunity exists to oversee multiple clinical trials for this evolving biotechnology company. You would be looked upon as the “expert” in clinical trials for the Company. The qualified candidate will be an MD, have experience in site selection, management (CRO as well as staff) and be well organized. Your industry experience could be in pharmaceutical, biotechnology or with a CRO.