JOBS – January, 2015

Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot.  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 . 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.  Hope to see more jobs and more people getting jobs this year.  :).

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.

Engineers conferring on prototype design, 1954

Engineers conferring on prototype design, 1954 (Photo credit: Wikipedia)


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

Electro-Mechanical Technician – Fremont, CA

A company that develops advanced injection technologies to simplify the complexities of the cardiac cath lab, has an immediate opening for R&D technician.
* 9 years of electromechanical technician experience
* 2 year Technical School degree in electromechanics or related field or a combination of education and experience
* 2 years of computer aided design experience
* 2 years experience directing and leading the work of others
* Problem solving skills with the ability to interpret drawings, schematics, and specifications
* Experience using CAD-3D Modeling
* Effective verbal and written communication skills
* Moderate level of computer experience including MS Office Suite and SolidWorks
* Demonstrated experience using a multimeter, soldering iron, oscilloscope, and spectrum analyzer
* High degree of organization skills and high attention to detail
* Ability to prioritize and handle multiple tasks
* Ability to work independently with limited supervision
* Proficient at specifying and evaluating electrical components based on performance, lifetime, and availability
* Demonstrated project management experience
* Demonstrated test report-writing experience

Preferred: 4+ years of computer aided design experience, * SolidWorks Proficient, * Experience providing technical support to circuit board manufacturing assembly, * Demonstrated knowledge of and familiarity with embedded systems and RF electronics, * Product development experience in a federally regulated engineering environment (FDA, ISO), * Experience defining, writing, and conducting test plans and reports.

Job Description & Responsibilities
Performs specified electromechanical engineering support activities under the guidance of an Engineer or Technical lead related to electro-mechanical design of medical device technologies, product and performance testing, and continuous improvement of the product design. The position is responsible for design, fabrications, assembly, validation, and implementation of development products and fixtures to support the design transfer of products into manufacturing operations.

Primary Duties and Responsibilities:
* Designs fixtures and test methods for validating product design and performance. Responsible for managing the ordering and delivery of fixture components and items from vendors or the internal Model Shop.
* Executes testing and validation protocols, records and analyzes data, and provides written reports to engineering team.
* Supports Product Development efforts at early stages up to design transfer. Provides support to engineers throughout the implementation and development cycles.
* Performs hands on activities such as design validation, pre-production assembly, testing and other technical activities to assist in product development.
* Assists engineers in identifying and resolving hardware design issues. Diagnoses the cause of electrical failures of circuit boards and operational equipment.
* Uses Solid Works CAD system to sketch and design fixtures and devices ensuring form, fit and functional requirements are met. Responsible for basic analysis of design in partnership with an Engineer.
* Responsible for initiating documentation changes and providing redlines to maintain the product information structure. Communicates issues and opportunities to engineering department to ensure bill of material (BOM’s), prints, process, forms, records, etc. are relevant and up to date.

Technical Engineering Support:
* Partners with Designers and Engineer, to develop and improve products, designs, fixtures, and process activities in the interest of continuous improvement and establishment of a Lean environment.
* Initiates design changes and coordinates the change order process to release product per the company’s Quality Management system. Responsible to maintain the design and information structure for use in the ERP system and engineering data base (PDM) DB Works. e.g.; BOM’s, prints, process, forms, records etc.
* Implements changes and maintenance of PDM and CAD systems as required. Assists IT and Technical Documentation Writer in annual CAD system updates, user rights management, and data base management. Creates and edits DB-Works and Solid Works API programs.

If interested in this opportunity then please submit resume with answers to the questions below – that is client requirement.

Describe your formal education:

Describe your experience working in medical device or a regulated environment.
Give an example of a work situation where you had minimal supervision and it was critical to work within a fluid or flexible environment.
Describe your experience with developing test fixtures and methods to evaluate a product and/or technology.
Describe your experience developing or using different types of CAD models (or Computer-Aided Design), electrical schematics, or other types of models. (New Q)
Give an example of a product and/or technology project where you had to apply both mechanical and electrical/electronic skills.


See link to my earlier blog on details to the three opportunities below.

Director of Analytical R&D for biologics company in China
Director of Patent Portfolio Management – China
Director of QA – China

Details for below positions coming soon……..please check back
Senior Quality Engineer – San Jose, CA
Senior Quality Engineer – Austin, TX
Entry level Engineers for medical device company – MA
Several opportunities in San Jose, CA

AND – I am looking for CONTRACTORS with following skills for work in South Bay, CA.  If interested in contract work, then please send your resume as an attachment to wd_darshana at hotmail dot com and indicate in the subject line – For contract work and name the work.  Please indicate in the email your expectations regarding compensation and brief summary of your skills.
* Electrical Engineering & Software
* Analog Design
* PCB Layout (FR4, Flex etc.)
* ASIC Design
* Embedded Systems
* TI MSP430, ARM, Cypress
* Software (Windows, Linux, C++, Android, iOS)
* Sensors
* RF Communications
* Bluetooth, Wi-Fi, 3G, 4G, GPS
* Antenna Design
* RF Test Labs
* Test Engineerin
* Test Hardware & Software
* Manufacturing Engineering
* Fixture Design
* DFM, DFT (Design for manufacturing, Design for Testability)
* Process Development
* Machine Shop Support

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