JOBS – June, 2014


For the opportunities below, please send resume at wd_darshana at hotmail dot com.  Please indicate in the email how closely the job description matches your background and identify gaps, if any.  Also, indicate your current compensation and compensation expectations.  Please note: All below opportunities are only for local candidates, with valid US work visa (when need arises for applicants from other countries, I will mention that under that specific opportunity).  Most of the activity I am seeing is on the engineering side – specifically Quality Engineering and Software Engineering.

Senior Analog Design Engineer – Mountain View, CA

The opportunity below is with a contract engineering company that designs devices & software for other companies that make wearable devices, home health, products for the aging, medical devices, industrial devices & other fascinating and challenging fields. The company is highly regarded for their work with sensors, wireless &  motion control.

Requirements:  Ten years of experience in analog design engineering is required. Ability to supervise others is highly desired. Experience designing circuits with switching regulators, analog-to-digital converters, sensor signal conditioning, and amplifiers (class A to class D) is required. Ability to design digital circuits is highly desired. Ability to program in a language is desired.

Successful candidate will lead a group of engineers from time-to-time & may be required to act as the primary interface with the customers. The person can work from home or work at the company.  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.

Network Engineer – CA

  • BS/MS EE or CS with 5+ Years of Experience
  • CCNP, Layer 2 / Layer 3 Protocols and Traffic Gens good knowledge
  • Strong Experience in Python and Automation Scripting

Awaiting details on below opportunities in Bay Area, CA

(1) VERY senior executive assistant (approx. $70-80K)
(2) clincial operations manager
(3) CMC operations manager
(4) clinical research associates (2)

Bioinformatics/ Statistics opportunity – Mountain View, CA

There is immediate opening for Bioinformatician/ Statistician for a company located in Mountain View, CA.  The company focuses on developing tests for cancer screening using blood samples.

Functions: This person will be responsible for analysis of clinical, complex genomic data sets, and statistical analysis, along with developing analytical tools and algorithms for early diagnostic feasibility, marker identification, classifier training & clinical validation studies.

Requirements: Master’s or Ph.D. in Bioinformatics, Statistics, and/or Computer Science with 2-3 years of applicable professional experience is required.  Also required, Experience in algorithm development, machine-learning, applied statistical modeling & classification; Working knowledge of multivariate statistical analysis methods including general linear models; Deep understanding of DNA sequence data & its analysis (mapping, variant calling, alignment tools, sequencing quality scores and their interpretation); Demonstrated expertise in the use of R for next generation sequencing data analysis & visualization; Experience &  solid knowledge in genomics: DNA sequencing, variation & annotation databases (dbSNP, refSeq, CCDS, UCSC, Ensembl, GO, etc.).  Also required: Advanced programming skills in: R, Matlab or SAS, C, C++, or Java; Scripting language such as Perl or Python; Experience with relational databases & SQL.

Software Quality Engineer – Danvers,  MA

A company located near Middleton, MA, and recognized as a pioneer & global leader in healthcare technology & innovation for assisting or replacing the life-sustaining pumping function of the failing heart, has an immediate Software Quality Engineering opportunity.  Responsibilities:  Understanding customer complaint trends & patterns for root cause understanding & corrective actions; program support for console includes review of design/software verification & validation protocols & reports; conduct design control compliance reviews, performs risk analysis, and FMEAs; Instill reliability mindset within team & provide guidance on reliability methods to team.  Requirements:  Bachelors in Engineering & 5+ years medical device experience and Design Control & risk management experience, required.  CQE or CRE certifications, a plus.

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Quality Manager –  Milpitas,  CA
Innovative medical device company, found by a veteran leader of several successful companies, has an opening for Quality Manager.  This is a great opportunity to work with disruptive, life changing technology with huge market potential, and to grow & build the Quality focused team.

Electro-Mechanical-Software Senior Engineer/ Manager – San Jose, CA

There is an opening for Electro-Mechanical Manager for a medical device company located in San Jose, CA. This is a great opportunity to participate at grounds level, to work on absolutely amazing technology with phenomenal market potential and a great team.  Requires 15+ years of experience that reflects breadth and depth in a variety of functional areas, an ability to think outside the box, and proven product development experience in medical device arena.

Senior Engineer – Mount Laurel, New Jersey

A medical device company with innovative cardiac modulation technology has an immediate opening for Senior Engineer.

Responsibilities: Provide project leadership in circuit design & development/implementation of reliability program under the direction of VP Product Development or, when applicable, Director-level R&D managers; Develop reliability test programs & test setups to implement test protocols; Conduct & document test protocols in the various areas of Product Development, including development-centered research, component & system reliability, failure analysis, etc.; Plan & schedule projects in his/her area of responsibility; Ensure compliance of design process regulations for area of responsibility, including QSR, ISO Standards & Corporate Policies; Specify & purchase components for test setups & prototypes; Procure & maintain engineering lab equipment in accordance with quality practices; supervise junior engineers & technicians.

Requirements: BS in Electrical Engineering, Experience in circuit design, at least 5 years experience in Industry as a R&D or reliability Electrical Engineer, & experience in microelectronic reliability & failure analysis required. Experience with military or medical instrumentation & prior experience in medical device/ defense highly desirable.

Engineering Technician – Mt. Laurel, NJ

A medical device company with innovative cardiac modulation technology has an immediate opening for Engineering Technician.

Responsibilities: Conduct circuit construction & test to implement reliability program under the direction of Senior Engineer; Implement reliability test programs & test setups to implement test protocols; Conduct & document test protocols in component & system reliability, failure analysis, etc.; Comply with regulations for area of responsibility including QSR, ISO Standards & Corporate Policies; Specify & purchase components for test setups & prototypes; Procure & maintain engineering lab equipment in accordance with quality practices.

Requirements: Experience in circuit design, construction & troubleshooting & at least 3 years experience in industry as R&D or reliability Electrical Tech & Associate or Bachelor’s degree in Electrical Engineering required. Experience in microelectronic reliability & failure analysis & Experience with military or medical instrumentation & Prior experience in medical, pharmaceutical, defense, etc. highly desirable.

QA Manager –  Mt. Laurel, NJ

An innovative medical device company working on treatment of chronic heart failure (“CHF”), has an immediate opening for a QA Manager. Requirements: BS with 8-10 years’ experience in Quality area; Knowledge of domestic & international regulations; Problem solving abilities & PC skills including Windows & Excel.

Responsibilities: Manage Quality Systems department; Assure compliance with domestic & international quality requirements; Support multiple product manufacturers; Prepare & execute all external & internal audits; Work with contract manufacturer to ensure that devices are manufactured in compliance with quality requirements; Review product complaints & ensure timely reporting; Identify & resolve quality issues in product development; Manage, supervise & train staff, oversee ongoing projects; Manage, review & revise documentation to ensure compliance with regulatory requirements; Schedule management review & presentations; Conduct & assist in responding to internal audits; Schedule & conduct supplier audits; Manage program for handling product returns, returned product evaluations (and repair/rework, where applicable), complaints and customer feedback in accordance with internal policies and procedures; Maintain a functional CAPA system in compliance with applicable regulations; Maintain ISO 13485:2003 facility registration in accordance with applicable standards; Provide guidance & supervision for Shipping/Receiving Clerk as it relates to completion of receiving inspections & other quality related functions; Ensure that the Quality Systems function is carried out in accordance with GMP & ISO directives.

Software   Developer – Mountain View, CA

Right now we are witnessing the onset of industrial internet paradigm where integration of big data with big machines is fundamentally changing everything.  This company provides innovative, modular, scalable and world class software solutions in this industrial-internet paradigm by leveraging sensor technologies, cloud computing, big data analytics and complex event processing.  There is an immediate opening for software developers with Windows skills.

Responsibilities: Be involved in all stages of SDLC, including analysis, design, implementation, testing, documentation & release; Participate in multiple projects with changing requirements; Maintain contact with clients/partners to       provide solution support& updates; Be ready to learn new technologies quickly.

Requirements: 4+ years of software development experience in  ASP.NET with MVC, JQuery; Be comfortable in data modeling, developing  stored procedures & triggers; Windows Communication.  Also preferred: Windows workflow foundation  4.0; Biztalk RFID server; Windows Mobile development; Exposure to Windows Azure

Location: SF Bay Area. Telecommute okay, but may need to attend client meetings: 6-12 months to full time.  Pay rate: $65 an hour but negotiable based on experience.

Software Test Engineer – SF Bay Area

Right now we are witnessing the onset of industrial internet paradigm where integration of big data with big machines is fundamentally changing everything.  This company provides innovative, modular, scalable and world class software solutions in this industrial-internet paradigm by leveraging sensor technologies, cloud computing, big data analytics and complex event processing.  Below is description for Test Engineer with the company.

Responsibilities: Be involved in all stages of SDLC: including analysis, design, implementation, testing, documentation & release; Participate in multiple projects with changing requirements: Maintain contact with clients/ partners to provide solution support & updates; Be ready to learn new technologies quickly.

Requirements: 4-6 years of software development experience in ASP.NET with MVC, JQuery; Be comfortable in data modeling, developing stored procedures & triggers, Windows Communication.  Also preferred: Windows workflow foundation 4.0; Biztalk RFID server; Windows Mobile development; Exposure to Windows Azure.

Location: SF Bay Area or Austin, TX.  Telecommute possible, 6-12 months to full time.  Pay rate: $35 per hour but negotiable based on experience.

Junior & Senior CRA – Orangeburg, NY

Medical device company with innovative treatment for chronic heart failure, located in Orangeburg, NY, has openings for Jr & Sr. CRA.  (Awaiting JD for Senior CRA but feel free to send resumes).

Junior CRA

Functions: Manage & organize administrative aspects in clinical department, create & maintain site personnel contact information, mass mailings, study binder preparation & distribution; Collect regulatory documents, ensure accurary, record reciept of key documents & contact site regarding missing records; Collect & Review study-related tracking systems to determine & report status of clinical trial documents. Send notifications to the clinical trial sites regarding their IRB renewal dates IRB; Maintain & audit study related files in compliance with department standard operating procedures; Review monitoring reports & assist with the follow-up & resolution of noted observations; Work with clinical trial sites to ensure all required testing is forwarded to & received by the Core Laboratories; Consistently use study tools & training materials & comply with standard operating procedures and policies; Perform data entry; Arrange periodic meetings for the Physician Adjudication Committee & assist the Clinical Director with the preparation & conduct of the meetings.

Requirements: Bachelor’s degree in life sciences or related, with 1-2 years medical device clinical research experience; Experience in communicating with hospital administrators and clinical research nurses; Working knowledge of FDA regulations and Good Clinical Practices; Excellent organizational skills; Good problem solving skills; EDC experience a plus; Conscientious person with an outstanding work ethic & strong personal discipline.


Quality Engineering opportunities- Middleton, MA

A company located near Middleton, MA, and recognized as a pioneer & global leader in healthcare technology & innovation for assisting or replacing the life-sustaining pumping function of the failing heart, has following immediate Quality Engineering opportunities.

Quality Engineer – Console Program Support

Requirements:  Bachelors in EE & 5+ years implantable medical device experience and Design Control & risk management experience required.  CQE or CRE certifications are preferred.  Comp: $80-95K
Functions: Understand customer complaint trends & patterns for root cause understanding & corrective actions; Program support for console includes review of design/software verification & validation protocols & reports; conduct design control compliance reviews, performs risk analysis, and FMEAs; Instill reliability mindset within team & provide guidance on reliability methods to team.

Quality Engineer – Disposables Program Support

Requirements:  Bachelors in EE highly desirable.  1 year medical device experience & CQE or CRE certifications are highly preferred. Comp: $60-85K
Functions: Understand customer complaint trends & patterns for root cause understanding & corrective actions; program support on heart pump disposables including review of design & process verification and validation protocols & reports; conducts design control compliance reviews, performs risk analysis, and FMEAs.

Biostatistician: US-CA-Valencia

Delivering on the promise of medical innovation and emerging technology. We deliver cutting edge products that help clinicians improve the lives of patients every single day that have a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the passion, integrity and creative spirit needed to thrive in an innovative company.

The company is a leading developer of emerging microelectronic technologies that modulate nerve activity to treat disabling disorders, including chronic pain. Today, the Company is investigating a number of innovative Deep Brain Stimulation technologies to treat other neural disorders, including migraine headaches, depression, Parkinson’s tremors, urinary incontinence, and erectile dysfunction. Join a dynamic global organization that is fueled by the diversity and best in class talent of its entire workforce.

Key Responsibilities:
– Act as a leader and subject matter expert for clinical study design and analysis.
– Collaborate with the rest of the Biostatistics & Data Sciences group on developing data collection and analysis strategies.
– Work closely with the Research Scientist, Project Manager, and Medical Director on development and execution of a range of clinical programs, including Feasibility, Pivotal, and Post-Market.
– Effectively communicate recommendations based on complex statistical concepts to Senior Leadership.
– Oversee and ensure the statistical integrity of all clinical programs.
– Lead the development and oversee the execution of the statistical analysis plans.
– Oversee the activities of the supporting Statistical Programmers in their implementation of statistical analysis plans.
– Represents Biostatistics on study teams and communicates with management and other team members regarding project/study status and timeline update
– Lead publication efforts in regards to data analysis and study results.
– Ensures the quality-controlled production of all tables, listings and graphs for clinical documents and publications.
– Independently lead research projects based on theoretical methodologies and/or publicly-available datasets to drive publications related to Biostatistics.
– Develop meta-analysis for existing clinical literature to enable data-driven strategic decisions for clinical program development and to support regulatory submissions.
– Collaborate with non-clinical colleagues (e.g. R&D, Marketing) on special projects.

Requirements
– Ph.D. in Biostatistics/Statistics or a field with a comparable quantitative/statistical emphasis
– 2 years experience in Biostatistics/Statistics research
– Excellent analytical and decision-making skills
– Excellent communication and presentation skills
– Strong independent statistics research skills
– Intermediate knowledge of SAS programming
– Excellent knowledge of experiment design and data analysis.

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