JOBS – July, 2020

 

Please see my current opportunities below. All opportunities are for local (US based) candidates with valid work visa and require deep 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 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

 

Cell Biologist with Islet Cell Experience – San Jose, CA

This is an opportunity to participate at grounds level with possibility of high potential outcome. Technology focuses on cure for diabetes and requires islet cell or related experience.

 

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.