Second Sight offers a fast paced environment that challenges employees to be both productive and creative. Team members are encouraged to explore new solutions to existing problems while, at the same time, remaining focused on the objective of restoring vision to the blind. Second Sight offers competitive wages and benefits. If this sounds like the right opportunity for you then please send your resume to:
Second Sight
Human Resources
12744 San Fernando Road, Building 3
Sylmar, CA 91342
Phone: 818-833-5000
Fax: 818-833-5067
Clinical Trials Assistant II
We are searching for an experienced, self-starting and organized Clinical Trials Assistant II. This position is responsible for providing administrative support to the Clinical Affairs and Regulatory Affairs departments, with a focus on clinical compliance-related items. The main responsibilities include maintaining records (i.e. record creation, data entry, and filing) for adverse events, clinical trial device orders/returns/accountability and customer feedback/complaint handling.
Essential Duties & Responsibilities:
•Handle all procedural, documentary and data entry aspects of adverse event reports received by the Company. Assist in the preparation of safety reports to regulatory agencies (e.g. FDA and Ministries of Health). Support the Director of Clinical Affairs in the preparation of logistics, materials, reports, and minutes for meetings of the clinical trial Safety Boards.
•Prepare customer orders for clinical trial materials and returned goods authorizations. Maintain device accountability database by entering in records of shipments and returns.
•Receive and process reports of customer feedback. Work with Regulatory Affairs, Quality Assurance and the Field Clinical Engineering teams throughout this process.
•Assist Clinical Affairs, Regulatory Affairs and Field Clinical Engineering personnel with administrative projects including copying, filing, data entry and other aspects of records management as required.
•Contribute to clinical in-house procedure development in areas of responsibility
•Work within cross-functional teams to provide assistance to meet the clinical and regulatory teams’ needs.
•Must be self-managing in prioritizing and delivering tasks against the departmental goals and requirements
Qualifications:
• Education: Bachelor\'s degree required, preferably in engineering, physical or biological sciences.
• Experience: 2 years experience in quality assurance, regulatory or clinical affairs or equivalent combination of education and experience.
• Knowledge & Skills:
• Practical working knowledge of compliance, quality assurance, procedures and records.
• General understanding of clinical trials.
• Excellent people skills. Team oriented.
• Effective written and verbal communication skills.
• Comfortable working in a fast-paced, dynamic work environment.
• Detail-oriented with strong organizational skills.
• Advanced working knowledge of Microsoft Word, Excel, Outlook and PowerPoint. Experience with Microsoft Access a plus
Director of Quality Assurance
We are searching for a highly qualified, organized and professional Director of Quality Assurance. This position is responsible for developing, establishing, implementing and maintaining quality assurance program policies and procedures to ensure that new or existing products conform to establish specifications and regulatory agencies’ requirements and meet the customer needs.
Essentially the Director of Quality Assurance performs the following:
•Analyzes, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of the management team.
•Determines appropriate staff levels and resources. Recruits, trains and provides guidance to staff.
•Develops and ensures budget and schedules meet company requirements.
•Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities
•Cooperates with other top management personnel in formulating and establishing company policies, operating procedures and goals
•Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements and operational procedures within program
•Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program
•Conducts management meetings with product assurance program department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments and to establish responsibilities and procedures for attaining objectives
•Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures
•Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders and vendor quality standards
•Confers with engineers about quality assurance of new and existing products to rectify problems
•Reviews technical publications, articles and abstracts to stay abreast of technical developments in industry
•Applies and coaches others on Quality System regulation requirements such as FDA QSR, European Directives and other applicable regulations.
•Serve as Management representative per Quality Management System requirements.
•Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Education: Master's degree or equivalent.
Experience: At least ten years related experience and/or training; or equivalent combination of education and experience in a QA function within the medical device industry.
Required Knowledge:
•Must be able to apply regulatory requirements such as QSR, European Directives, ISO standards and other regulatory requirements.
•Drives the use of quality improvement tools and continuous improvement method
Skills/Abilities:
•Coaches others in the appropriate statistical analysis and problem solving techniques
•Excellent people skills, team oriented
•Effective written and verbal communication and organizational skills
Process Development in Biomedical R&D
This role will focus on the processing of miniature electrode structures for nerve stimulation devices. Candidate should have exposure to practical and theoretical aspects of microfabrication, including how techniques such as pattern transfer, deposition, etching and metrology are used to create functional components. Academic or industrial experience emphasizing fabrication and testing of circuit boards, integrated circuits, photovoltaics or microsystems. Candidate should have an interest in biomedical technologies and possess the ability to apply fundamental analytical concepts to the development and evaluation of novel microfabrication processes. Work involves aspects of R&D and manufacturing. Prior work in a cleanroom environment, with training in chemical handling and safety, is beneficial. Exposure to the documentation requirements of a regulated industry such as medical or aerospace is beneficial.
Particular responsibilities of this position include:
•Perform R&D processes according to informal procedures and analyze results.
•Create and retain records of R&D process development work.
•Contribute to process development efforts by generating concepts for improvement, implementing and evaluating demo runs and qualifying new processes.
•Perform manufacturing process operations according to documented procedures.
•Complete relevant manufacturing documentation.
•Plan and execute tasks according to priority and schedule.
•Contribute to documentation of equipment, parts and procedures.
•Generate experimental protocols and reports.
•Build and support vendor relationships.
•Support manufacturing operations.
Strong verbal and written communication skills are required. Candidate will be expected to possess the ability and initiative to complete assignments independently, though guidance and support will be provided by supervisor and project team. A keen eye for details is crucial.
Candidate should also possess appropriate skills in mathematics, word processing and spreadsheet software. Ability to draft and interpret engineering drawings in CAD software, to apply rigorous scientific method and to communicate results effectively is important.
Experience Required:
At least 3 years of relevant industry experience or a BS degree in an applicable field.
