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The incumbent in this position is responsible for overseeing the financial strategy, forecasting, audits, safeguarding of assets, risk management, treasury functions, operational activities and strategy, business objectives, and organization of an independent corporation. The incumbent works with senior executives and the Board of Directors to establish financial, accounting and strategic business goals for the organization to meet specific business objectives. This position is responsible for management, legal, tax, financial compliance, Board of Directors and security reporting requirements. The CFO advises CEO on the development, implementation and management of the company’s financial, risk management, information technology, material handling and human resources functions. Requires considerable financial leadership experience, with experience in medical devices preferred. Visit www.regenesisbio.com/about/careers for a full job description.

TAE Technologies is leveraging proprietary science and engineering to tackle the world’s biggest challenges. A recently formed sister company of TAE is looking into cancer-fighting applications using a particle accelerator similar to those that have been developed for the fusion application. We are looking for a Medical Device Manufacturing Engineer who is responsible for providing manufacturing and quality assurance and compliance and testing support to R&D.
Responsibilities:
• Leads design transfer activities to support transition from R&D to manufacturing.
• Develops equipment and process validation requirements (Process FMEA, IQ, OQ, PQ).
• Provides engineering support to manufacturing.
• Determines process improvements to improve product quality.
• Generates internal quality documentation such as quality plans, SOPs and inspection procedures. Ensure QA, FDA and ISO compliance in all areas of responsibilities.
• Provides all planning necessary to ensure effective product acceptance based on Device Master Record.
• Reviews production schedules and support product acceptance activities.
• Assists in monitoring field quality issues and analyzing field returns.
• Performs data analysis and investigations. Tracks quality trends and initiates action items to resolve issues.
• Participates in internal and external quality audits.
• Uses statistical tools to analyze data, make acceptance decisions, and improve process capability.
• Design of tooling, fixtures, and packaging to aid in the supplier build and assembly processes and ensure safe transport.
• Design tests to verify and validate design.
• Provide technical review and assessment when qualifying new suppliers.
Job Requirements:
• B.S. degree in an Engineering discipline.
• 5+ years of related experience in medical device industry
• Detailed knowledge of ISO 13485 and the FDA 21 CFR, Part 820, Quality System Regulation.
• Certified ISO 13485
• Knowledge of six sigma methodologies preferred.
• Experience in managing/coordinating engineering activities.
• Experience with ERP systems.
• Excellent organizational, problem-solving, and analytical skills.
• Good interpersonal skills.
• Ability to identify problems, and develop and implement actions to resolve them.

Under the direction of the Program Director, the position is responsible for the management and administration of GPS-BIOMED (Graduate Professional Success in the Biomedical Sciences), a professional development program for graduate students and postdocs funded by the NIH-BEST initiative. Responsibilities include coordinating all of the activities including career development workshops, mixers, and seminar series; organizing an annual orientation event and the registration process for participants; and cultivating an alumni network that will serve as mentors and speakers for a variety of events. In consultation with the Program Director and other participants, the Coordinator will invite speakers for workshops, seminars, and mixers, and will serve as the primary liaison with internship partners, local biotechnology businesses, external contractors, and program evaluators.

Familiarity with the NIH-BEST initiative as well as diverse career paths for biomedical PhDs preferred. Familiarity with the Southern California industries, science policy fellowships, and advocacy training is also a plus.

The Invention Transfer Group (ITG) offer graduate students, post docs, or professional students at UCI a hands-on introduction to university technology transfer and intellectual property management. Under the direction of a Licensing Officer at ITG, fellows will assist the office in conducting technology assessments, prior art searches, writing invention summaries, and initiating market research of UCI inventions. This opportunity gives fellows experience analyzing innovative technologies, and an understanding of the patenting and commercialization processes, while providing an excellent resource to the UCI inventor community.

We are looking for a senior mechanical engineer that has broad experience in development. They must be able to work on a variety of projects, create designs and mechanisms in Solidworks and manage the prototyping and testing of systems using our extensive in-house prototyping capabilities.
Omnica is a unique place to work where your creativity and ability to get things done can be realized. Most employees here are long term with an average tenure of at least 15 years. We want to add to that experience base with people who are passionate about their craft and have medical device experience.

The Research Associate is responsible for assisting senior R&D staffs to design, develop, and validate clinical diagnostic
assays spanning a wide range of Next-Generation sequencing and microarray technologies.

Position Duties & Responsibilities:
– Aid in the design and development of clinical diagnostic assays for use in a CLIA/CAP regulated setting.
– Participate in drafting Standard Operating Procedures for new assays.
– Perform research experiments, such as primer design and preparation, PCR, electrophoresis, gel imaging and
analysis, Sanger Sequencing, Next-Gen sequencing library preparation, aCGH microarray labeling, and
sequencing analysis.
– Perform general research and development laboratory maintenance tasks.

Position Requirements:
– BS or MS degree in a life sciences field: Biology, Molecular Biology, Biochemistry or related field.
0-2 years laboratory research experience in an academic or industrial setting.
– Strong understanding of molecular and cellular biology.
– Expertise with Microsoft Office products, especially Word and Excel.
– Excellent verbal and written communication skills and ability to communicate and work effectively and
positively with all levels of the organization.

*Contact Aarani Arulmol, the Associate Project Manager of R&D at Ambry Genetics.

The primary duties of this position are to assist other Automation Team members in assay automation development, as well as support the Clinical Laboratory by aiding in recovery and troubleshooting validated laboratory instruments. This position also plays a role in designing, optimizing, validating, maintaining, and troubleshooting automation tools for our clinical diagnostic assays.

*Contact Aarani Arulmoli, the Associate Project Manager of R&D at Ambry Genetics.

This position is responsible for initiating the development and managing the progress of multiple assays/tests. The
position will evaluate relevant literature, research data, new technologies, and software programs to support new assay
development at Ambry.

*Contact Aarani Arulmoli, the Associate Project Manager of R&D at Ambry Genetics.