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My client is taking immunotherapy to the next level in the fight against cancer and infectious diseases. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba.
Job summary
Lead Human Factors & Usability Engineering activities for new product development programs and drive usability improvements for current products.
• Support Product Management and Product Engineering personnel in establishing human factors (HF) and usability-related requirements for new products and product line extensions
• Conduct internal and external Usability testing throughout the product development process, from formative testing of early prototypes through summative testing of final designs.
• Oversee outside consultants to effectively and efficiently support product development efforts within the company.
• Develop and maintain the uFMEA for new and existing products.
• Develop and maintain product user manuals
• Create product concept models such as story boards, mockups, workflow diagrams, use cases, etc.
• Work with external test houses on IEC 60601-1-6
Minimum requirements
• Extensive knowledge and understanding of the Human Factors Usability Engineering process for medical devices
• human factors education and experience with various human factors research methods
• Understanding of Risk Management Process based on IEC 14971
• In-depth knowledge of IEC 62366 and AAMI HE75
• Practical knowledge of FDA QSR 820 and ISO13485 require
• Minimum 7 years industry experience working in human factors / usability with Medical Devices

We are seeking a an experienced Director of Manufacturing for a very promising start-up company in the neurovascular field. This is an exciting opportunity to be an early employee in a fast-paced environment led by a seasoned team of industry experts. The company is preparing for production and is looking for a an experienced manager to lead the manufacturing operations.

ZebraSci is searching for a talented Quality Engineer to work at our site in Temecula, CA. This role is primarily responsible for leading complex root cause failure investigation and troubleshooting of customer complaints and product non-conformances. Strong technical aptitude and experience is a must, preferably in engineering, chemistry, biology or other life sciences field. High level of technical writing ability is required. This position is responsible for writing experimental protocols and reports, failure investigation reports, and supporting documentation within the Quality System (NCMR’s, Complaints, CAPA, Deviations, FMEA, Quality Plans etc.). This position will regularly present to external customers and peers with updates on failure investigation and troubleshooting activities. Experience interacting with Regulatory Bodies (FDA, ISO) is required. The use of data in decision making is essential. Advance skills in statistical techniques and tools is a must. The ideal candidate is a champion of Quality System compliance with a deep understanding of medical device QSR’s.

Essential Duties:

Provide leadership in performing and documenting root cause failure investigation activities for our contracted clients.
Write/edit/approve method development and method transfer reports.
Write/edit/approve QC investigation reports.
Present Failure Investigation findings to contracted clients and management.
Mine data for development of corrective actions.
Represents the Quality Control department in evaluating failures, performing technical root cause analysis and developing and executing corrective and preventative actions.
Perform statistical analysis of data from experiments and manufacturing process trend monitoring.
Evaluation and improvement of Quality Control plans through the entire manufacturing process optimization, matrix testing, and in-process testing of strips and components.
Supports Receiving/Inspection functions with creating / reviewing raw material specifications.
Prefer a B.S. in Engineering/Chemistry/Biology/Technical Discipline or equivalent combination of certification and work experience.

Experience in Quality and Manufacturing Systems in Laboratory or Medical Device industries.

ZebraSci Background:
Medical Device and Biopharma firms have gained an edge utilizing ZebraSci’s Medical Device development services and innovative inspection equipment. From Compliance, Regulatory and Human Factors to our ISO 17025 accredited COMBINATION PRODUCT testing lab and technologies, ZebraSci is your partner in success. The team at ZebraSci is comprised of cross functional teams that are passionate about developing and launching combination products. ZebraSci offers consultation, project management and test solutions throughout the entire product life-cycle; ensuring your product is launched, on time, on budget, and in compliance with ISO 13485 and FDA 21 CFR 820 Our experienced team has provided solutions for drug delivery devices and combination products for nearly ten years. Our cross-functional team is geared to deliver thoughtful, integrated solutions to your device projects. By combining experience, a unique methodology, customized tools and a passion for results, we help our clients produce tangible results from strategy through launch and beyond.

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.