Posts Tagged FCE
All US based opportunities require valid US work visa and prior experience in biomedical industry. Most of my current needs are in engineering and all engineering opportunities require medical device experience. I have added some other opportunities in science, sales, BD etc.
I will be adding more opportunities. If interested in any opportunities below, please send me an email (resume as an attachment) at wd_darshana at hot mail dot com and include position title in the subject line. Please include in the email, how well the description matches your background and where the gaps are, if any. All leads or referrals are greatly appreciated.
Director of Engineering – San Jose, CA
(Medical device implantable experience and hands-on engineering passion required).
Automatic Test Equipment Engineer – San Jose, CA
Immediately available. Requires medical device experience. Send in resume ASAP.
Manufacturing Quality Engineer – San Jose, CA
Immediately available. Please send in resume ASAP.
Biochemist – San Jose, CA
Requires MS with 6+ years experience or PhD with 3 years experience in Biochem, Molecular Biology or related. Immediately available, send in resume ASAP, if interested.
Quality Assurance Manager – San Jose, CA
Senior Manufacturing Engineer – San Jose, CA
Manufacturing Technician – San Jose, CA
Senior Mechanical Engineer – San Jose, CA
Biologist – San Jose, CA
Software Sales – San Jose, CA
Seed stage company offering a suite of subscription based software products, supported by cloud infrastructure, has an exciting opportunity for software sales professional, to join as member of the core founding team. Although at pre-funding stage, the company is already generating revenues, with massive and growing database of products that can help scientists make environmentally friendly decisions throughout product development life-cycle. Extensive customer relationship experience is required. Familiarity with SciFinder, Reaxys etc. is required.
Engineering Technician – Mt. Laurel, NJ
An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Engineering Technician, in Mount Laurel, New Jersey.
Requirements: BS in EE, 3+ years experience as R&D Electrical Engineering Tech/ Testing Engineer, Prior experience in strongly regulated industries (e.g. medical, defense etc.), Prior experience with reliability tests and assembly.
* Conduct all assigned tests, under the direction of a senior engineer.
* Implement reliability test programs and test setups to implement test protocols.
* Conduct and document test protocols in component and system reliability, failure analysis, etc.
* Ensure compliance with regulations including QSR, ISO Standards and corporate policies.
* Specify and purchase components for test setups and prototypes.
* Procure and maintain engineering lab equipment in accordance with quality practices.
Senior Business Development Role – EU
Reporting To: Head – Global BD to manage all aspects of business development across the CRO portfolio of services; secure and retain business through professional, consultative & proactive sales activities directed at key decision makers.
Maintain knowledge of all appropriate cross-sell opportunities; Continued awareness of competitive activities, positioning & pricing; Work with regional & international counterparts to develop & close integrated opportunities; Analyze potential opportunities & develop sales plans for each target account; Develop in-depth knowledge of customer organization; Represent company at various industry conferences & trade shows; Prepare & lead sales presentation; Educate team in customer culture, operational needs/methods & sales techniques; Handle follow-up related to sale & drive completion of contract; Maintain high visibility in customer organization; Monitor customer satisfaction; Record, plan & coordinate customer sales activities in CRM (SALESFORCE) system.
Requirements: BS or MS in Life Sciences – PhD. preferred; 10+ yrs experience in BD / sales for CRO, CMO or related in life sciences; Ideally industry experience in combination of pharma or biotech in discovery research, CMC or commercial manufacturing technical roles; Solid understanding of drug discovery & development process; Track record of achievement in terms of sales goals; Experience working with international clients & colleagues; Ability to visualize & integrate company’s service portfolio across the drug development continuum; Ability to cross-sell & credibly represent company services to clients; Ability to work from home-based office
Additional details: The position is located in EU. Base pay: between 100,000 to 125,000 euros, car: 800 euros per month, VPP: 5% of base pay; Pension benefits: as applicable per country, Designation – Regional Director, BD
Analog Design & Embedded Systems Engineering Leader – San Jose, CA
Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for analog design engineering leader, in San Jose, CA. Stock options, in addition to working on something truly exciting and life changing, would be a huge upside in this opportunity. Requirements include, years of steady experience and passion for engineering problem solving, natural ability to take leadership role (MBA not required). This opportunity is immediately available and if you are engineering problem solver then it is one of the most exciting opportunities you may come across.
Leads Engineer – Austin, TX or San Jose, CA
Requires BS in mechanical engineering, related to biomedical engineering and 10+ years medical device experience. Highly desired, experience designing and developing medical products with implantable leads like cardiac pacemaker leads, proficiency in CAD, SolidWorks, and experience with MatLab, hands-on experience for fabricating prototype leads and related fixtures and tooling.
- Design and develop new conceptual leads in groundbreaking fields of medical devices.
- Prototype lead designs and perform preliminary bench top testing
- Develop processes for advanced lead designs
- Develop, document, and implement test protocols for design verification and process validations
- Design tooling for manufacture and assembly of implantable leads
- Support in vivo and clinical evaluation of developed components
EMBEDDED SOFTWARE/FIRMWARE ENGINEER FOR MEDICAL DEVICES – Austin, TX or San Jose, CA
Requires: BS in Electrical or Software Engineering & 5+ years exp designing & developing embedded systems for medical devices; expertise in embedded C/C++, in optimization for performance & memory usage; exp developing apps that run a variety of OS/RTOS targets; working in structured environment w/ source control & bug tracking systems; exp developing low level device drivers for SPI, I2C, USB, LCD, ADC, DAC, exp with variety of CPU architectures (Arm Cortex M3/M4, TI MSP430 etc.; exp w/ board bring-up; effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes, etc. Requires proficiency with Microsoft Office tools.
* Develop firmware for very low-power, battery powered systems consisting of a mix of analog, digital & RF circuitry in highly integrated, low power embedded designs
* Participate in design activities at architectural & implementation levels
* Design & implement error checking & fault handling, robustness & safety features
* Document software design & implementation
* Support V&V testing, work with V&V team to develop test plans & protocols
* Adhere to standards to help ensure compliance with FDA, ISO, AAMI & UL standards.
Director, Quality Assurance – Mt. Laurel, NJ
In the process of getting filled.
Requirements include: Bachelors degree; 10-12 years experience in QA including medical device industry experience and supervisory/ management experience; & Good working knowledge of domestic & international requirements & regulations such as FDA, ISO, GMP etc.
* Work with contract manufacturer to ensure that devices are manufactured in compliance with US and international quality system requirements.
* Participate in product development teams on behalf of Quality Systems. Identify and resolve quality issues throughout product development process to assure successful audits and regulatory filings.
* Review all product complaints and ensure timely reporting of those events to domestic and international regulatory agencies as necessary.
* Schedule, conduct and assist in responding to internal audits , supplier audits and inspections.
* Maintain a functional CAPA system in compliance with applicable regulations
* Maintain ISO 13485:2003 facility registration in accordance with applicable standards.
* Provide guidance and supervision for Shipping/Receiving Clerk as it relates to completion of receiving inspections and other quality related functions.
* Ensure that the Quality Systems function is carried out in accordance with GMP and ISO directives.
* Review and revise quality system documentation to ensure compliance with domestic and international quality and regulatory requirements.
* Manage, supervise and train staff, oversee projects ongoing within departments, carry out departmental administrative duties.
* Schedule and complete timely management review presentations.
* Manage the document services function to ensure that quality systems documents, records and regulatory submissions are controlled.
* Manage product release and non-conforming product activities
* Maintain program to ensure adequate training of personnel on quality system documentation. Work with HR Department on companywide training activities.
* Ensure employees training on the Quality Systems Regulation and key international regulations and standards.
* Manage the program for handling product returns, returned product evaluations (and repair/rework, where applicable), complaints and customer feedback in accordance with internal policies and procedures.
Senior Clinical Research Monitor: Located anywhere (requires 80% travel)
Position Summary: Responsible for data quality & regulatory compliance at US clinical trial investigational sites. This responsibility is carried out by conducting on-site monitoring visits with Investigator & other research personnel. Highly competitive salary.
* Orient site personnel to study protocol/procedures
* Monitor compliance to FDA Regulations & study protocol
* Monitor & promote compliance to local IRB reporting regulations
* Manage study site activities through frequent on-site visits
* Perform initial, interim & closeout study visits
* Communicate findings to investigators & study staff at the site
* Prompt reporting of compliance issues to in-house staff
* Follow-up on all outstanding issues to ensure each matter is addressed in a timely fashion
* Provide timely communication & written reports to the Clinical Affairs department after each monitoring visit
* Schedule on-site monitoring activities & travel in conjunction with company travel policies.
* May be required to supervise additional field monitors
* Up to 80% travel required.
Education and Experience Requirements
* This position requires a RN, BS, or similar degree (CRCC) with at least 5 years experience in monitoring clinical studies. The candidate must be very familiar with all FDA regulations governing IDE clinical trials.
* Experience in cardiac medical device related clinical trials
* Experience in clinical trial data management
Field Clinical Engineer (FCE) – Germany ( several locations: North Bavaria and Thüringen)
Requirements: BS in Engineering, Science or related; 5+years experience with use of invasive cardiovascular medical devices; knowledge of device-based cardiac rhythm & heart failure management; Prior experience working with clinical studies; Ability to quickly analyze & resolve clinical/technical issues; Frequent traveling to investigational sites, corporate offices, investigator meetings & industry meetings.
* Develop a strong rapport with clinical sites by acting as consultants to support the site’s needs.
* Responsible for supporting all field-based activities at clinical sites.
* Drive enrollment by ensuring that investigational sites receive the necessary support in order to enroll, implant, and follow patients in a manner consistent with the clinical protocol.
* Support implant procedures and follow-ups at clinical sites
* Share clinical / technical experiences with other personnel in order to improve understanding of product behavior, improve product performance and product acceptance by customer.
* Communicate activities and issues at clinical sites with other company personnel
* Fulfill all administrative requirements including the collection of relevant technical data and completion of necessary documentation
Senior Electrical Engineer – Mt. Laurel, NJ – may be filled soon
An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Senior Electrical Engineer in Mount Laurel, New Jersey.
Requirements: B.S. in EE; 5+ years experience as R&D EE in regulated industries (i.e Medical, defense, etc.); Applications development & PM experience; exp writing protocols, reports, regulatory documents; Understanding of patent applications & processes. Exp in circuit design (Analog & mixed-mode circuits) & with digital signal processing algorithms, a big plus.
* Provide project leadership in product design & specifications, under direction of VP Product Development.
* Develop reliability tests programs & setups to implement test protocols
* Work closely with vendors (i.e design subcontractors) on product requirements & specifications.
* Conduct design reviews & ensure compliance of design regulations including QSR, ISO standards and corporate policies.