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 Mechanical Engineer
A bay area company with world class team, has an exciting opening for Senior Mechanical Engineer with experience in developing class 3 medial device products and understanding core research that went in to developing that product. Requires an ability to run experiments and generate viable ideas. This is an opportunity to participate at grounds level in an opportunity with high potential outcome.
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 Mechanical Engineering Technician – San Jose, CA
Requires 15+ years of experience.
Senior Electro-Mechanical Engineering Technician – San Jose, CA
Requires 15+ years of experience.
Senior & Junior Mechanical Engineer – San Jose, CA
The Senior Mechanical Engineer is responsible for evaluating and improving the company’s current drug delivery system while maintaining high quality and reliability standards. This will be achieved by testing the system and optimizing components or subassemblies as needed. In addition, he/she will be required to work with quality and regulatory to develop complete documentation for the device. The successful candidate will work independently and use sound judgment to deliver optimal solutions. This is a hands-on position that requires interaction and collaboration with a cross-functional team.
Responsibilities
- Evaluate the current design and identify opportunities to realize improvement in product consistency and increased throughput in a manufacturing environment
- Show proof of concept through prototyping and supporting test data, and coordinate implementation with appropriate stakeholders
- Take full ownership of documentation by following internal design control SOPs, leading verification/validation activities, and participating in phase reviews
- Create 3D models, engineering drawings and bill of materials
- Create comprehensive work instructions and manufacturing SOP’s
- Work with quality to resolve any issues with components or processes
- Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
- Comply with company’s policies and guidelines regarding quality and regulatory
Qualifications
- Bachelor’s Degree in Mechanical Engineering
- Senior engineer requires 10-12 years experience and junior engineer requires 3-5 years hands-on experience in a design environment
- Experience with creating engineering drawings, BOMs, and product specifications
- In-depth experience with complex mechanical systems that interact with biology
- Prior experience in a medical device company
- Experience with design control process for medical devices and implementation of product in to manufacturing
- Working knowledge of FDA regulations and ISO, cGMP, QMS standards
- Good understanding of DFM and lean manufacturing
- Excellent verbal, written, presentation and interpersonal skills
- Strong analytical and problem-solving skills
- Knowledge and/or hands-on experience with machine shop tools
- Proficiency with SolidWorks required
- Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
Preferred Qualifications
- Knowledge /experience with plastic injection molding
- Masters’ degree or higher in Mechanical Engineering or Biomedical Engineering
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 designing unique tests, developing fixtures, and analyzing the data. Additional duties may include reporting failures, and assisting in improving manufacturing processes to prevent prototype failures, support R&D with component design work, test fixture design, support verification testing, and interface with manufacturing to implement new design updates into the pilot manufacturing line.
Responsibilities
- Work with multi-disciplinary teams to define tests and perform verification testing
- Design and build appropriate test fixtures for completing the tests
- Assist engineering and bio team on evaluation of device failures and complete test reports to review improvements with the team
- Collaborate with manufacturing to create product assembly tooling, fixtures and work instructions
- Assist R&D and manufacturing in process development, including molding, bonding processes for parts, and component design
- Comply with company’s policies and guidelines regarding quality and regulatory
Qualifications
- BS in Mechanical Engineering
- 3-5 years of industry experience
- Must be hands on and adept at building and debugging fixtures
- Fluent with SolidWorks
- Excellent verbal, written, presentation and interpersonal skills
- Strong analytical and problem-solving skills
- Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
Preferred Qualifications
Prior experience in a medical device company desired
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.
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