NeoVista, Inc - Careers

Careers

For employment consideration, please submit your résumé to jobs@neovistainc.com.

Clinical Research Associate

Performs and coordinates all aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Represents NeoVista, Inc. in the global medical research community and develops collaborative relationships with investigative sites and client company personnel. Required to travel 60-70% on average.

Education and Experience:

Bachelor's Degree in life sciences or related field or certification in a related allied health profession from an appropriately accredited institution (i.e.: RN, MT, PA, RPh or RT)
Minimum one year as a clinical monitor

Knowledge, Skills and Abilities:

Effective clinical monitoring skills
Experience with Electronic Data Capture a plus
Experience with Ophthalmology a plus
Demonstrated ability to attain and maintain a working knowledge of GCPs and applicable SOPs
Basic computer skills and ability to learn and become proficient with appropriate software
Demonstrated understanding of medical terminology
Effective oral and written communication skills with ability to communicate effectively with medical personnel
Strong customer focus and excellent interpersonal skills
Strong attention to detail
Proven flexibility and adaptability
Ability to work in a team environment and independently as needed
Valid Driver's License and ability to qualify for and maintain a corporate credit card with sufficient credit line to allow for extensive business travel

Senior Manufacturing Engineer

This is a Sr. Manufacturing Engineering position that will develop manufacturing processes for disposable medical products. In addition, this person will support development of the products with work including writing or verifying specifications, maintaining product process, designing fixtures, plant layout, test processes, equipment and raw materials to ensure the concepts and/or prototypes meet their requirements.

The individual will develop, evaluate and implement operational plans involving methods, materials, equipment, and measurements to achieve startup of pilot production and manufacturing engineering in the areas of growing volume of disposable products and reusable mechanical assemblies.
Interface closely with design team to assure new products are designed for manufacturability and manufacturing capabilities are ready per project launch schedules.
Responsible for efficient and rapid new product transfer to Manufacturing
Plan for and implement new manufacturing processes required to support the company sales plan including new products.
Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/MDD regulations
Hands on manufacturing implementation experience.

Specific Job Function:

Assist in the management of manufacturing deployments through Integration, Test, Staging, and Production environments
Develop, document, validate and implement automated, semi-automated and manual assembly and testing equipment and tooling manufacturing processes required to produce disposable products.
Review and update existing process and SOP’s
Provide technical support to the Global Materials Manager to influence the suppliers and external manufacturers and ensure that reliability at component level is done properly
Raise product quality levels by training teams and individuals in the use of manufacturing procedures, systems, equipment and methods.
Implement Statistical Process Controls (SPC) in manufacturing to monitor process capability to ensure process or performance of the components operate within the control limits and/or specification
Support device complaint investigation, failure analysis, and implementation of corrective action
Participate in FMEA activities to ensure process shortcomings are identified and appropriately addressed
Manage production of products including ensuring operators are properly trained, production schedule is adhered to, Manufacturing Process Instructions are written, device history record is accurate and working with production personnel in identifying areas for improvement
Identifies and implements the necessary actions to correct and prevent the recurrence of nonconformities through the Corrective and Preventive Action Process
Write and execute design verification and validation test plans, analyze data, prepare reports, and present findings
Experienced regarding packaging, shipping and testing requirements
Ensure all equipment and tooling are properly documented and under calibration and preventative maintenance control as required.
Support completion of the required IQ/OQ/PQ elements of process validation
Work with Engineering and Quality to ensure products are designed taking into consideration ease of manufacture and that products will adhere to performance, cost and quality requirements.
Work with Quality and Engineering to maintain an approved Quality Management System that meets the requirements of GMP, QSR, and ISO13485.
Initiate product pilot production to support bench tests, clinical tests, and limited sales and marketing requirements.
Support production of products including ensuring operators are properly trained, production schedule is adhered to and that production paperwork is accurate.
Support Operations with inventory control including parts counts and tracking.
Identify root causes of manufacturing process nonconformities. Identifies and implements the necessary actions to correct and prevent the recurrence of nonconformities through the Corrective Action and Preventative Action process.
Provide manufacturing engineering expertise assisting Purchasing, Quality, and Engineering for vendor qualification and evaluations, including vendor audits.
Review and approve engineering drawings.
Support test and process validations.
Possible travel up to 25%, including international

Minimum Qualifications, Education and Work Experience:

Well organized with extensive Process Engineering experience in Medical Device field.
BS/MS degree in Industrial, Manufacturing, Mechanical, or Electrical Engineering discipline, or related discipline with a strong emphasis in product transfer
Minimum 3 to 7 years recent experience in medical Electro-Mechanical/disposable Manufacturing or Process Engineering in the medical device field.
Proficient in Microsoft Office Applications (Project, Power Point, Visio, Excel, Word)
Skilled at experimental design, statistical analysis of data and interpretation of results. Thorough understanding of failure analysis
Strong knowledge of various component fabrication processes, including, NC machining, metal stamping, cabling/harness, injection molding
Strong team player and team builder
Startup company experience preferred
Superior interpersonal and communication skills
Knowledge of FDA Good Manufacturing Practices, ISO 13485-2003
Knowledge of design and fabrication techniques for plastic components and assemblies.
SolidWorks
Experience with solvent bonds, preferably with tubing high desirable
FMEA experience is preferred
Lean Manufacturing and Six Sigma knowledge is preferred
Physical requirements - requires lifting up to 50 pounds
Familiarity with Quality System Regulations QSR/QSIR, ISO 13485, Medical Device Directive (MDD), CE Marking and Canadian Medical Device Regulations is desirable.
CQE desirable.
Certified Six Sigma Green Belt desirable

Manager, Manufacturing/Production

Position summary:

The Manager leads a Manufacturing function responsible for developing, evaluating and executing strategic and operational plans and leading the manufacturing function to support, define, and implement necessary methods, materials, equipment, and measurements to achieve startup of pilot production and manufacturing engineering in the areas of growing volume of disposable products and reusable mechanical assemblies.
Interface closely with design team to assure new products are designed for manufacturability and manufacturing capabilities are ready per project launch schedules. Responsible for efficient and rapid new product transfer to Manufacturing
Plan for and implement new manufacturing processes required to support the company sales plan including new products.
The Manager of Manufacturing reports directly to the VP of Operations
Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/MDD regulations
Ability to work with cross-functional teams, problem solve and drive solutions to meet internal and external customer requirements

Specific Job Functions:

Assist in the management of software and hardware deployments through Integration, Test, Staging, and Production environments
Investigate/Troubleshoot/Resolve issues and anomalies with the Integration, Test, and Staging environments
Perform system level testing and analysis
Design and develop new and unique manufacturing methods and procedures, special equipment, innovative test procedures, special analysis of failure techniques, and communicate these advanced concepts by way of detailed technical reports
Work with the Global Materials Manager to influence the suppliers and external manufacturers and ensure that reliability at component level is done properly
Raise product quality levels by training teams and individuals in the use of quality testing procedures, systems, equipment and methods. Implement state-of-the-art product process engineering focus and improvements in design and development of product reliability
Implement Statistical Process Controls (SPC) in manufacturing to monitor process capability to ensure process or performance of the components operate within the control limits and/or specification
Support device complaint investigation, failure analysis, and implementation of corrective action
Participate in FMEA activities to ensure process shortcomings are identified and appropriately addressed
Manage production of products including ensuring operators are properly trained, production schedule is adhered to, Manufacturing Process Instructions are written, device history record is accurate and working with production personnel in identifying areas for improvement
Identify root causes of manufacturing process nonconformities using CAPA and Six Sigma techniques. Identifies and implements the necessary actions to correct and prevent the recurrence of nonconformities through the Corrective and Preventive Action Process
Write and execute design verification and validation test plans, analyze data, prepare reports, and present findings
Experienced regarding packaging, shipping and testing requirements

Minimum Qualifications, Education and Work Experience:

Well organized with extensive Process Engineering experience in Medical Device/Diagnostic field.
BS/MS degree in Manufacturing, Mechanical, or Electrical Engineering discipline, or related discipline with a strong emphasis in product transfer
Minimum 5 to 10 years recent experience in medical Electro-Mechanical/disposable Manufacturing or Process Engineering in the medical device field. 4+ years at Manager Level
Proficient in Microsoft Office Applications (Project, Power Point, Visio, Excel, Word)
Skilled at experimental design, statistical analysis of data and interpretation of results. Thorough understanding of failure analysis
Strong knowledge of various component fabrication processes, including, NC machining, metal stamping, cabling/harness, injection molding
Strong team player and team builder
Startup company experience preferred
Superior interpersonal and communication skills
Knowledge of FDA Good Manufacturing Practices, ISO 13485-2003

This well financed company in Northern California is offering very competitive salary and benefits for the right person.

Health Physicist

Primary responsibilities: This employee will assist the Corporate Radiation Safety Officer in implementing a comprehensive Radiation Safety Program compliant with federal, state, and local regulations.

The HP will develop and/or revise procedures and tools for use within the Radiation Safety Office and will be responsible for satisfying deadlines for radiation license and registration renewals; mandatory reporting and for performing the required sealed source testing and inventory. The HP will collect, monitor, track radioactive components and will assist with their disposition. He or she will investigate and prepare dose estimates in cases where employee dosimeters are lost or record a dose above the threshold set by NeoVista. As needed, the HP will conduct and document radiation surveys and will provide radiation safety training or radiation-related information to employees or NeoVista customers. The HP will review and interpret radiation control regulations and will assist with preparation, revision, and implementation of official NeoVista procedures related to radiation safety.

Requirements:

Required qualifications and skills: B.S. in health physics or a closely-related field. 1+ years applicable experience in radiation protection. Excellent organizational and communicational skills. Strong computer skills, Microsoft Office and Project preferred. Ability to work independently. Excellent attention to detail. Ability to work effectively and tactfully with all levels of employees, as well as directly with external medical facilities and healthcare personnel; effective oral and written communication skills. Ability to handle a variety of tasks, willingness to travel both domestically and internationally, and flexibility to change job assignments with efficiency.

Senior Mechanical Design Engineer

This position will lead efforts in the design and development of sterile, single-use, Class III medical devices and reusable tools in the field of ophthalmology, specifically in the area of design and integrity of commercial surgical devices and their packaging requirements. Previous experience bringing new products to market through the complete product development cycle is required. The Sr. Mechanical Design Engineer is responsible for developing, documenting, and validating complex new mechanical product designs, as well as improving existing designs to meet the needs of our customers. This individual will be expected to;

Design complex designs, specifications and manufacturing processes involved in components and assemblies for surgical systems which meet the requirements of the Medical Device Directives (CE), ISO and FDA.
Investigate clinical requirements and assess field reliability data to improve existing product designs as necessary.
Work with external suppliers and vendors, manage projects to design, develop and manufacture components and systems.
Lead and/or contribute to all phases of design reviews.
Write study protocols, test functional engineering prototypes and prepare reports to document results per the document control requirements.
Analyze and test product designs; manage the development and qualification of initial fixtures and processes to assemble components.
Fabricate or coordinate the fabrication of functional mechanical prototypes.
Develop product assembly instructions.
Develop and perform component verification testing and product validation testing.
Support production of final product by troubleshooting process and component problems.
Provide cross functional support to Manufacturing, Marketing, Materials, Test Engineering, and Service to facilitate transfer of designs.
Develop Design History Files and Technical studies per regulatory requirements.
Knowledge of Risk Management techniques, FMEA and Hazard Analysis methods.
Works independently to plan and schedule activities necessary to meet the project's objectives and timelines.
Work with physicians to develop market/design requirements and appropriate performance measures.
Collaborate with marketing, manufacturing and customers on design concepts for new products.
Contribute significantly to the intellectual property portfolio.

Requirements:

BSME required, MSME preferred with formal ISO training a plus.
Minimum 8 years experience designing medical devices.
Proficiency using CAD to design mechanisms and machinery; ProE and/or Solidworks preferred.
Hands-on engineering with a proven ability to work well in a team environment.
Experience in high yield, reliable and commercial introduction of Class III medical devices.
Understanding of materials fundamentals and processes in the fields of plastics and metals, including experience with metal fabrication processes, mechanical design, and knowledge of medical materials technology and characteristics.
Proficiency in Microsoft Office and Project.
Comfortable with all phases of the formal product development lifecycle, including design, implementation, debug, verification, qualification, and transfer.
Strength in design analysis.
Good communication and documentation skills.
Knowledgeable in the operation of machine shop equipment.
Strong understanding of component selection criteria, and design for reliability and manufacturability. Prior tooling/fixturing design experience and an understanding of machining and injection molding processes is desirable.
Leadership, attention to detail, organization, and technical knowledge in a broad set of design disciplines.
Ability to execute complex designs and handle several concurrent assignments in a team environment.
Experience with radiation producing devices is preferred.

Global Project Manager

NeoVista, Inc. is a medical device start-up developing an intraocular epiretinal radiation device intended for the treatment of the wet form of Age-Related Macular Degeneration (AMD). The device is currently being used in human feasibility studies outside the United States (U.S.) to treat neovascular AMD. NeoVista, Inc. has entered into a definitive clinical study to support filing for regulatory approval to market the product in the U.S.

Job Description:
Responsibilities encompass the overall management of international medical device projects including budgeting, timeline adherence, internal and external communications, and project deliverables. This position will interact with operations, marketing, and finance to ensure the successful relay of clinical trial data to further enhance the value of NeoVista medical devices.

Provide leadership for study start-up, enrollment, and follow-up activities.
Mentor, train junior team members.
Develop study documents including case report forms, logs, and educational materials.
Provide a central point of study communication for company, extended study team and senior management.
Facilitate study progression by overseeing study activities, including internal and CRO activities.
Ensure the study is tracking to study specific patient accrual milestones.
Ensure timely data collection, entry and processing.
Facilitate submissions of imaging to central reading centers.

Requirements:
BS in biological sciences or related field and/or 5-10+ years clinical development experience in biotech/pharmaceutical industry setting required. Management experience including outsourcing to CROs, excellent organizational and planning skills and management of investigational sites is essential. Strong working knowledge of Good Clinical Practice required. Experience running global clinical trials preferred.