Please see my current opportunities below. All opportunities are for local (US based) candidates with valid work visa with all required industry experience. If you have an interest then please send an email (resume as an attachment) at wd under score darshana at hot mail or find me on Linkedin.
Senior & Junior Mechanical Engineers
A bay area company with world class team, has an exciting opening for Senior & Junior Mechanical Engineers to design, develop & validate semi or fully automated equipment used for scale-up of high volume, disposable devices.
Responsibilities: Develop concepts & ideas for improving tooling, create new tooling, evaluate current manufacturing processes & workflows, take ownership of design, create User Requirements Specs, conduct concept reviews, show proof of concept through prototyping, support test data, coordinate with stakeholders for V&V, launch & documentation, created 3D models, engineering drawings & bills of materials, participate in design FMEA, plan to mitigate risks, and work with outside vendors, machine shops, contract manufacturers.
Requirements: BS in ME plus 3 to 13 years of medical device industry experience with complex mechanical/ electromechanical design, extensive experience with precision mechanisms pneumatics, servo systems, tooling/ fixtures, motors, belts/ pulleys, gears, actuators, sensors and experience creating engineering drawings, BOMs, products specs is required. Also required knowledge of material properties, heat treatment & surface finish, understanding of DFM & lean manufacturing, and track record with medical device manufacturing methods, RDA reqgulations, ISO, cGMP & QMS standards is required. MS in ME, experience with plastic injection molding, knowledge of DOE, SPC, JMP/ Minitab, experience with metal stamping, laser cutting, chemical etching, familiarity with sterilization process & aseptic environment and PLC programming would be a big plus.
Mechanical Engineer R&D – San Jose, CA
Senior Mechanical Engineer is responsible for evaluating and improving the current drug delivery system by testing and optimizing components or sub-assemblies as needed. He/she will work with quality & regulatory to develop complete documentation for the device.
Responsibilities: Evaluate current design & identify opportunities for improvement, show proof of concept through prototyping and supporting test data, document internal design control SOPs, lead V&V activities, create 3D models, engineering drawings & bill of materials, create work instructions & manufacturing SOP’s, work with quality, and outside vendors, machine shops, contract manufacturers and comply with company’s policies & guidelines regarding quality & regulatory.
Qualifications: BS in ME + 5 years hands’on experience in medical device design environment, experience with creating engineering drawings, BOMs, product specs, experience with implementing product into manufacturing, knowledge of FDA regulations & ISO, cGMP, QMS standards, understanding of DFM & lean manufacturing, experience with machine shop tools & SolidWorks. Master’s degree in ME or BME and/or experience with plastic injection molding, a huge plus.
Senior Catheter Design Engineer – S. San Jose, CA
There is an immediate opportunity for a Senior Catheter Design Engineer with 15 to 20 years experience in catheter design engineering in a stealth mode company that is less than 2 years away from getting its first two devices 510 K approved and launched. The company is led by a visionary leader and has highly experienced engineering and management team. This a hug opportunity to participate at grounds level in what is a truly exciting and game changing technology that is poised to change the quality of care of cardiac patients, with a potential to save millions of healthcare dollars, on regular basis. Experience is IVUS engineering a huge plus.
Manufacturing/ Test/ Quality Engineer – S. San Jose, CA
A stealth mode cardiovascular company with experienced engineering team, led by a serial entrepreneur, has an immediate opening for Manufaturing/ Test/ Quality Engineer. This requires 10 plus years experience in the filed of catheter engineering.
Catheter Design Mechanical Engineer – S. San Jose, CA
A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an immediate opening for Catheter Design Mechanical Engineer. The position requires 5 to 10 years of experience in catheter engineering, a can do, problem solving attitude, excellent conflict resolution skills and an ability to handle uncertainty.
Program/ Project Manager – S. San Jose, CA
A stealth mode cardiovascular company with world class engineering team, led by a veteran leader with prior experience in building a company, has an opening for Program Manger with experience of working in catheter engineering industry and a demonstrated history of managing projects all the way from conceptualization, team building, cost estimation, implementation, regulatory 510 (K) approval, and production support to launch. Experience in catheter engineering and leading 510K approval program is absolutely essential.
Supply Chain Management/ Strategy Leader – S. San Jose, CA
A stealth mode startup with exciting technology with potential to alter the quality of care of cardiac patients is looking for Supply chain management/ strategy leader. This position requires extensive experience across the end to end supply chain spectrum in Class 3 medical device industry. It requires proven track record of significant contributions to cost reduction and productivity improvement and experience in cross-functional leadership.
Senior Technician/ Manufacturing Engineer – S. San Jose, CA
A stealth mode cardiovascular company, led by a serial entrepreneur with prior experience in building a company, has an opening for Senior Technician/ Manufacturing Engineer with 4 plus years experience in catheter engineering.
NGS Research Scientist – Foster City, CA
Job Functions: To work on NGS assays for RNA seq, single cell and immune profiling projects & work collaboratively to develop new assays based on requests from the commercial team. Design & execute on NGS assays including 10X single cell & TCR/BCR repertoire profiling; Perform proof-of-concept experiments to enable development of new NGS applications for epigenetic and immunotherapy solutions; Collaborate w bioinformatics scientists to assist in data interpretation for single cell & TCR projects & generate presentations & reports for commercial projects; Generate data for application notes for marketing & BD needs.
Qualifications: Masters in Genetics, Immunology, Cancer Biology, Molecular Biology or related field; 2+ yrs NGS experience. Also, Hands-on experience in NGS techniques including sample extractions, RNA-seq, 10X, library prep & exp in low-input & single-cell NGS applications & exp in designing, executing, & troubleshooting for molecular & cell biology techniques a plus.
Logistics Lab Associate – Foster City, CA
This position will report to the Lab Manager & will handle procurement, distribution, storage, delivery & inspection of incoming & outgoing products to the lab.
Responsibilities: Maintain inventory system, procure lab supplies from verified vendors, provide monthly reporting, execute POs, drive cost optimization, negotiate w/ vendors/ service providers, liaise w/ lab scientists on inventory, for example, ensure kits/reagents are not expired, manage iSensix alarms, store items appropriately & efficiently, & keep in stock at all times general use items (such as gloves, pipette tips, PCR plates, etc), track NGS inventory, meet reporting deadlines, generate & discuss reports w/ lab managers, handle shipment of receipts & support facility initiatives. Requires ability to move/ stock supplies weighing up to 45 lbs.
Requirements: Ability to work independently, 2-5 years prior work experience as lab assistant at biotech/ diagnostic/ pharma/ lab, attention to detail in written instructions & documentation, basic computer skills in Word, Excel, willingness to work in two different time zones.
Senior Electro-Mechanical Engineering Technician – San Jose, CA
Requires 15+ years of experience.
Mechanical Testing & Fixture Design Engineer – Milpitas, CA
There is an immediate opening for mechanical testing and fixture design engineer. Good understanding of how to design and set up tests is required. Responsibilities include design unique tests, develop fixtures, report failtures, help improve manufacturing processes, support V&V testing, interface with manufacturing to implement new design updates into pilot manufacturing line and analyze data. BS in ME, fluency in SolidWorks, and 3-5 years of medical device industry experience is required.
This position will be responsible for preparing patent applications and will prosecute company’s global patent portfolio. 3+ years of medical device industry experience as a scientist or engineer plus 3+ years of experience as a patent prosecutor is required. Also required USPTO registration and CA license. Highly preferred, 3+ years experience designing/ developing medical devices and at least 3-% of patent prosecution experience across a variety of medical devices and a basic understanding of pharmacodynamics and pharmacokinets and a degree in EE or material science.
Leadership Opportunity – Milpitas, CA
There is a senior level leadership opportunity that requires prior experience with leading a neurological medical device company.
Leadership Opportunity – Union City, CA
A senior level leadership opportunity requires experience with taking a biotech company public.