JOBS – February, 2015

Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot.  My imminent openings are for Quality Engineering and for Software Engineering (both for medical devices).  Please also notice contract opportunities at the end.  All US opportunities are for US based and local candidates.  Opportunities exist in China that are open to all and you can see description in my previous blog at specific one is for Director of Analytical R&D in Suzhou. When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are.

Senior Electrical Engineer – Austin/ San Antonio – TX

A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience.  Experience with closed loop, analog design hardware, microcontrollers, actuators  and ultra low power consumption circuit design highly desired.  More details will follow soon but if interested, please send resume as an attachment (with some details in email) at wd_darshana at hotmail dot com.

Senior Software/ Algorithm Engineer – Fremont, CA

A company providing innovative diagnostic & therapeutic products &  services to enable interventionalists in providing superior patient care, has an immediate opening for Senior Software Engineer, in Fremont, CA.  Position Summary: This position will be responsible for developing the next generation of image processing algorithms for company’s revolutionary medical devices for cardiovascular business. Individual will participate in object-oriented software development projects using C++ and Qt for a Linux environment. Communicate effectively, as well as to present information to a group in a professional manner. Work cooperatively as part of a team with people from various facilities and technical backgrounds.

Primary Duties and Responsibilities:
Design, develop, and optimize next generation image processing algorithms
Perform lab research and algorithm testing
Develop multi-threaded software for desktop applications
Design code for maintainability and unit tests
Identify, evaluate and mitigate technical project risks
Support formal verification and validation process and participates in transfer of products from R&D to manufacturing
Team player working in a geographically distributed team
Accurately estimate time and resources for completion of specific features/project
Assist in maintaining ISO certification and 510(k) submission requirements

Qualifications & Required Skills:
Minimum BS degree in Computer Science, Computer Engineering, Electrical Engineering, Applied Math, Biomedical Engineering, or related field; Strong background in image processing; 5+ years of software development experience; Excellent coding skills in C/C++; Proficiency in MATLAB; Experience designing object-oriented and distributed software; System level architecture design experienc; Experience with source code management systems like GIT, SVN, Clear Case

Experience developing software for medical device applications for user interaction and control
Experience with medical imaging algorithms like segmentation, co-registration, 3d reconstruction
Experience with python, DICOM, OpenGL graphics
Other: * Travel requirements are moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be less than 20%.

Please submit resume at wd_darshana at hotmail dot com, with answers to following questions in the email.  This is client HR’s requirement. 
Please provide information on your formal education:
Please describe your software engineering experience as it relates to design, proof-of concept, detailed design, code, unit and integration testing:
Please describe your experience utilizing UML modeling language, DiCom, MFC, BOOST, STL and C++ :
Do you have experience working Linux OS environment? If yes, provide more detailed information:

Senior Design Engineer with Embedded Hardware & Firmware Skills – Santa Clara, CA

A reputed contract engineering company has an immediate full time opportunity for  a Senior Design Engineer with Embedded Hardware & Firmware Skills.  A rounded individual is desired who has an interest and ability in a wide range of technologies.  The successful candidate will lead a group of engineers from time-to-time and may be required to act as the primary interface to the customers at times.  The company designs devices, firmware, and software for other companies and has a reputation for quick response with high quality work.  The person must enjoy working with customers and have good communication skills.  The person must work well on a team of high performing engineers.  The person needs to be organized.  The person must work well with others and be flexible as schedules and priorities change.

Technical requirements: Ten years of experience in embedded system design engineering is required.  Ability to supervise others is highly desired.  The person should have experience designing circuits with microprocessors from PIC to ARM, FPGAs, Bluetooth, and WiFi as well as experience with programming in C or C++ on these devices.  The person must enjoy learning and be able to learn quickly.  The ability to design and program FPGAs is desired.
This could be a work-at-home job, or work at the company site, in Santa Clara, CA.


Summary:  Medical device design and manufacturing company, located near Santa Cruz, CA, focusing on custom injection molded plastic parts, has an immediate opening for Quality Engineer.  Position focus is on providing support in the development and maintenance of company’s quality systems, support activities related to the development and qualification of new product development for medical device components and assemblies as well as supporting existing products.
* Write FMEAs, review and write protocols and reports for new products
* Ability to multitask on a variety of Quality System compliance and improvement initiatives in a hands-on dynamic environment and be involved with the design, procurement, validation and qualification activities including test, inspection and medical device contract manufacturing service processes.
* Responsible for the facility measurement equipment calibration and maintenance program.
* Collects, collates and analyzes manufacturing data for warranty and nonconformance to determine and report product quality trends.
* Conducts analysis of inspection and tests of a routine degree of complexity and provides recommendations accordingly. Develops quality control inspection requirements and techniques to achieve measured improvement. * Implements the Failure Analysis Process for internal and external nonconforming product to determine appropriate corrective action.
* Support Receiving, In- process and Final Inspection of various components and subassemblies for medical device products to support quality compliance and shipment goals as workload requires.
* Assist in the development and implementation of Quality System processes.
* Attend various product meetings with Engineering, Sales, Support, Marketing, and customers to address product requirements, customer concerns and training issues. Work toward and support Company/Department/Team goals including; QSR and ISO compliance, revenues, training utilization, customer satisfaction, and others as appropriate.
* Qualify and implement document changes involving product or process changes
* Coordinate the reporting, analysis, and resolution of material non-conformance incidences
* Provide support in the timely resolution of product complaints and/or safety issues
* Conduct quality audits and develop subsequent preventive action programs
* Assist Regulatory Affairs Department in the preparation of audits and reports for regulatory agencies.
* Perform Supplier Quality Audits and, as appropriate, Internal Quality System Audits; identify root cause of non-compliance and ensure timely/effective corrections and lor corrective preventative actions are implemented
* Drive effective root cause corrective action through internal and supplier surveillance and corrective action requests.
* Report MRB performance metrics and maintain corrective action database.
* Review and report in-process data from manufacturing processes and facilitate corrective and preventive actions

Requirements: 5 – 7 years’ experience in Quality, medical device, regulatory, and or a medical device manufacturing environment; BS in Bachelor of Science in Quality, Business, Mechanical Engineering, Engineering or related field; Certification, CQE, CQA a plus; Experience as an ISO Lead Auditor desirable; Must be able to communicate effectively at varying technical levels with a customer audience; Hands-on manufacturing experience in mechanical or medical device assemblies. CMM, MicroVu, Vision Systems Programming experience; Working knowledge of U.S. and international medical device regulations is desirable Working knowledge of desktop computer office software, Visio Tools, CAD software and e-mail is required; Excellent verbal and written communication skills; Flexibility to handle multiple tasks and meet timelines; Excellent analytical and problem-solving skills combined with a strong technical presence.

Senior Quality Engineer – Austin/ San Antonio – TX

A company working on innovative drug delivery technology has an immediate opening for senior quality engineer. Great opportunity to work at grounds level and grow into leadership role, in addition to the upside of stocks.

Key Responsibilities:
* Lead QA for: R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance; Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support company’s facilities, including the respective incubated companies, projects and technologies with an appropriate QA system for each segment
* Educate colleagues and support in-house uptake & implementation of these systems organization-wide* Support the following functions: Regulatory Affairs: provide appropriate documentation and materials to support filings for US and international trials and approvals; Intellectual Property: supporting documentation; Business and Commercialization, including due diligence documentation
* Develop & implement documentation systems for these business functions, including electronic systems, with help of to –be-hired Documentation Specialist

Key Qualifications
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable*
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Led and grown QA organizations with a hands-on, leadership- by-example approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE
* Supported multiple complex projects and start-ups: able to prioritize.
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class III implantable devices
* Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator

Key Job Parameters
* Full-time position located in Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development


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