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.

JOBS: September, 2019

Please see some of 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.

Clinical Trial Manager – San Jose, CA

Ideal experience: 8+ years experience in medical devices, ideally in neuromodulation.  Required, experience running clinical trials, and working with clinicians and medical centers.

Head of Regulatory – San Jose, CA 

Candidate must have 15+ years experience in bio/pharma industry. Experience working with biologics and taking a drug to market in the US and EU is essential.

Mechanical Engineer – San Jose, CA

The Mechanical Engineer is responsible for evaluating the current manufacturing processes and making design improvements to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling and/or creating new tooling and equipment. The successful candidate will work independently and use sound judgment to deliver optimal manufacturing solutions. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate the current manufacturing processes /workflows and identify opportunities to realize improved product consistency and increased throughput
· Develop concepts and ideas for improving the exiting tooling as well as creating new tooling including semi-automation where applicable
· Take full ownership of tooling /fixture designs, conduct concept reviews, show proof of concept through prototyping coupled with supporting test data, coordinate with appropriate stakeholders for successful verification /validation, launch and documentation
· Create 3D models, engineering drawings and bills of materials
· Create comprehensive work instructions and manufacturing SOP’s
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Establish working relationship with outside vendors, machine shops, contract manufacturers and manage the work accordingly
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing or related engineering fields
· 5-7 years hands-on experience in a manufacturing environment
· In-depth experience with complex mechanical /electromechanical design
· Extensive experience with precision mechanisms, pneumatics, fixtures /tooling and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
· Experience with creating engineering drawings, BOMs and product specifications
· Deep knowledge of material properties, heat treatment and surface finish
· 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
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with electrical /electronics and PLC programming a big plus
· Knowledge /experience with plastic injection molding
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

Sr. Molding Engineer

Job Summary

The Sr. Molding Engineer is responsible for evaluating the current molding processes and leading the effort to increase throughput, quality and reliability. This will be achieved by redesigning the current tooling, creating new tooling /equipment as well as leveraging outside molding expertise. The successful candidate will become the resident expert in the areas of plastic injection molding and material selection. This is a hands-on position that requires interaction and collaboration with a cross-functional team.

Responsibilities

· Evaluate /characterize the current molding processes and identify areas of improvement while focusing on rapid manufacturing scale-up
· Work closely with the consumable engineering group and make recommendations for molding improvements such as use of alternate materials, parts consolidation, setup /process optimization etc. without compromising the design intent
· Conduct design concept reviews and present fresh ideas, new technologies and creative ways to take the current molding process to the next level
· Show proof of concept through rapid prototyping and supporting test data
· Take full ownership of all injection molding initiatives, coordinate with appropriate stakeholders from initial concepts through FAI, optimization, successful verification /validation, launch and documentation
· Work closely with Process Engineering through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
· Develop /optimize molding parameters and establish best practices in molding methodologies
· Work with external companies as needed to outsource injection molding activities and manage the vendors through all phases of the projects including user requirements, RFQ, vendor selection, concept & design followed by verification /validation
· Create comprehensive work instructions and manufacturing SOP’s
· Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications
· Bachelor’s Degree in Mechanical, Manufacturing, Plastics or related engineering fields
· 7-10 years of extensive, hands-on experience with plastic injection molding including but not limited to mold design, capability studies and process characterization /optimization
· Experience with rapid prototyping and multi-cavity plastic injection molding
· In-depth knowledge of material science /plastics properties and metrology techniques
· Experience with creating engineering drawings, BOMs and product specifications
· Good understanding of DFM and lean manufacturing
· Excellent verbal, written, presentation and interpersonal skills
· Strong analytical and problem-solving skills
· Prior experience with FDA regulations and ISO, cGMP, QMS standards
· Knowledge and/or hands-on experience with machine shop tools
· Deep knowledge of GD&T as well as proficiency with SolidWorks
· Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks

Preferred Qualifications
· Knowledge /experience with micro molding
· Knowledge /experience with DOE, SPC, FMEA
· Experience with metal stamping, laser cutting and chemical etching
· Familiarity with cleaning and sterilization processes

JOBS – August, 2013

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 (except one for post doc) require several years of industry experience and are only for local candidates, with valid US work visa.  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled.  Also, I am awaiting job descriptions for following positions & will be posting the details soon – Quality Assurance Engineer, Mechanical Engineer, Senior ME Technician and Software QA Tester.  Immediate need in many of the opportunities below, is experience in the area of medical injection molding.  Leads appreciated. (BTW – I love live entertainment  and if your lead results in a hire, if reminded, I will love to invite you and cover for your ticket, to accompany me to the theater for one of the upcoming plays of your choice at one of South Bay area theaters).

R&D Technician – San Jose, CA

There is an immediate opening for a Medical Device Senior Technician in an early stage company, located in San Jose, CA,  developing a novel approach for the oral delivery of large molecules.

Responsibilities: Perform experimental device component fabrication, device assembly; device testing and analysis, maintenance and troubleshooting on manufacturing equipment and process, Develop fixtures for testing or manufacturing, and Compile data on device testing.

Requirements: 5+ years work experience in an industrial or laboratory environment; experience in medical device or pharmaceutical operation, with test equipment including instron, burst, weight, pressure, and force test equipment and with basic chemistry laboratory processes including measuring, mixing solutions, chemical storage, and laboratory safety.

Also required: Demonstrated mechanical skills, Ability to read and follow written instructions, Ability to interpret engineering drawings, Familiarity with plastic manufacturing processes including molding, forming, and bonding, Familiarity with principles of machine operation, machine control systems, pneumatics, and motors, Computer skills including Word, Excel, Outlook, Ability to operate independently and function as a team member, Good written and verbal communications skills., Familiarity with principles of GMP and/or GLP operations.

Territory Account Manager for Medical Injection Molding Operations – Santa Cruz, CA

Responsibilities: Initiate and evolve customer relationships for the purpose of securing production business for company’s medical injection molding and assembly operations, located in Minnesota and California.  Activities include researching and calling potential identified customer opportunities and promoting capabilities and technology through presentations and meetings.  Interaction with internal engineering group to facilitate completion of quoting opportunities on a timely basis.  Presentation of quotes and ultimately the closing of new business.

Job Functions: Work to exceed individual/company annual sales goals; Participate in weekly sales meetings; Provide weekly sales activity reports; Sales pipeline reporting is required for the sales director, for review and discussion at the monthly managers’ financial review meeting; Work industry trade shows and follow up on leads, as required.

Major areas of accountability: Initiate and Evolve Customer Relationships to Meet Annual Sales Objectives – 75%; Account Maintenance – 20%; Monthly Reporting – 5%.

Financial Responsibility: Expense management.

Requirements: Bachelor’s Degree; Basic knowledge of molding and assembly for medical device manufacturing; Ability to understand technical drawings and related requirement information; Minimum of 2 years previous technical selling experience required.

IP Legal Secretary/ Paralegal – San Rafael, CA

Requirements : Strong docket filing experience; Thorough knowledge of patent & trademark prosecution process; Experience with Electronic Filing with USPTO and Pair; Ability to type at least 60 words per minute; Knowledge of time slips program to facilitate accounting & billing functions; Experience preparing time reports, expense reports, client bills & conflict checking forms; & Familiarity with legal terminology.  Absolutely required, 5+ years experience with patents and dockets; 5+ years experience working as legal secretary.

Responsibilities: Provide secretarial & administrative support; Assist with preparation & filing with USPTO and of foreign patent & trademark applications; Generate transmittals & formal USPTO documents;  Handle foreign patent & trademark prosecution matters including PCT & foreign prosecution forms; Monitor patent prosecution docket; Prepare & file maintenance fees, assignments, missing parts & IDSs; Proofread & redline work for accuracy of copy, format, grammar, punctuation, and syntax; Type & edit computer system legal & other documents (including memoranda, bills, timesheets & project work) from handwritten or typed materials; Copy, distribute, send by courier or express service, File & otherwise handle completed work; Receive, screen & transmit telephone calls, conference calls & messages; Handle incoming & outgoing mail; Set up & maintain files. Should work independently, take initiative, set priorities & see projects through completion; Work in a team setting.

Software Quality Assurance (SQA) Engineer – San Francisco, CA

A software company that provides innovative, modular, scalable and world class solutions by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is scaling, in pre-funding stage.  The company is expanding core engineering and product development team & looking for high caliber, senior, Quality Assurance Test Engineers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment.

Responsibilities: Acquire in-depth understanding of the company’s products to ensure high quality of products; Support the development of workarounds, testing, necessary documentation (including investigation and resolution of issues; Assist in coordinating delivery management tasks; Track requirements and software release management for clients; Be first escalation point for supporting company’s customers.

Requirements: Must have strong client support & project management background.  Must have 4-6 years of implementation & post production support experience for enterprise applications; 3-4 years of functionality, testing, bug tracking, writing test cases experience; strong communication skills; demonstrable hands-on experience with quality management tools; technical skills in SQL, HTML based documentation.  Highly preferred: skills in developing and managing on-line help content.

Location: San FranciscoBay Area.  Telecommuting is okay but will need to attend client team meetings – so must be in driving distance.  Duration: 6-12 months, full to part-time, 1099, corp to corp, contract to hire.  No visa sponsorships.

Post-Doc ———- San Jose, CA

A medical device company has a post-doc position.  Requires PhD in Material Science, BioEngineering, BioChemistry or related areas, ideally from a top notch school.  Must have excellent references.  Send resume as an attachment with brief description of the academic experience and projects, in the body of the email.

Injection Molding Tooling Engineer – Santa Cruz, CA

A contract manufacturing company has an immediate need for Injection Molding Tooling Engineer.  This position will lead and own the design, development, and procurement of all new injection mold tooling, insert mold tooling and fixtures and oversees all design changes, modifications and repairs to new and existing tooling. They will be part of the Operations team on all new product launches.

Responsibilities include, Develop primary design concepts for tooling working in conjunction with our Customers Engineering Staff and the Director of Engineering; Establishes and maintains relationships with outside tooling sources; Directly manage the construction of all new tooling with domestic and off shore tooling suppliers; Directly manage the construction of all new gauges and fixtures needed with new tools; and Communicate with supplier and customer on a technical level. Responsibilities include the establishment of technical and quality requirements for programs; Design modifications to tools and fixtures using Solidworks, or Pro E; Responsible for tracking tooling budget to quote; Work directly with the Program Managers to ensure customer and supplier terms are followed; Review of piece part prints, tolerances and GD&T and communicate requirements to Quality; Attend APQP meetings and take part in PFMEA, Control Plan and Line Documentation meetings; Direct efforts of outside tool and die shops this include selecting suppliers and reviewing and approving designs while working in conjunction with the Program Manager; Insures deliveries by outside vendors that meet the program requirements and meet established budgets for tooling procurement; Maintain CAD files associated with tooling in compliance with associated internal document control procedures; Takes part in mold start up trials at the tool maker, internally and at offsite locations; Tracks timing of tools using MS Project; Ability to tear down and maintain molds when needed.

Requirements include, Ability to manage multiple tooling sources simultaneously; An understanding of injection molding processing; Is knowledgeable in automation equipment for labor reduction efforts; Creates validation protocols; Understands and knowledge of IQ,OQ,PQ validation processes; Must be able to travel to suppliers and customers domestically, travel to tooling sources in Asia may be required.  Minimum of 10 years experience managing injection mold construction and 5 years Solid Works/ ProE Experience is required.  Also must have direct experience with managing tool construction.  Medical thermoplastic injection molding experience is a huge plus.

Patent Attorney – Sunnyvale, CA

Innovative medical device company with a broad line of product portfolio, has an opening for Senior Patent Attorney for VP level position.  Must have 15+ years of medical device and biotech patent prosecution experience in a law firm.

Manufacturing Manager – Santa Cruz, CA

Job Functions & Responsibilities: This position will be responsible for managing production operations to ensure business objectives are achieved at the lowest cost consistent with customer delivery and quality requirements.  Responsibilities include: Manufacturing scheduling and staffing; Production methods and standards; In-process product quality; Materials responsibilities including procurement and inventory management; Safety policies and procedures; Hourly employee development, performance management and relations; Continuous improvement and Lean Manufacturing Leadership and implementation; Budget management and cost containment.

Requirements: Knowledge of Manufacturing concepts and principles; Experience in Lean Manufacturing, Process management/statistical process control, Production layout/design/method, Manufacturing equipment management and knowledge of Business and office system software.  Also required, experience in Capacity planning; Scheduling/MRP; Budget management; Team development of both hourly and salaried direct reports; Problem analysis/solving; Managing internal and external relationships.  Bachelors degree or equivalent experience required.  Also required, Medical/Cleanroom/Assembly experience; Experience managing a 24/7 operation; Ten years manufacturing experience; Management experience; Experience in the Injection Molding/Plastics industry.

Accountability measures include, Quality, Safety, Productivity, Utilization, Service, Deliver, Cost efficiency and continuous improvement, and Employee development and retention.

Software Developers – SF Bay Area (contract, part-time)

Big data and machines are revolutionizing the way we operate. A software company that provides innovative, modular, scalable and world class solutions, in this industrial-internet paradigm, by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is now scaling in pre-funding stage. Some of the clients include Cisco Systems, Applied Mateirals, Huawei, Agilent, HP, Foxconn, Fletronics, and Sanmina that are using this software to transform their engineering and manufacturing operations. The company is expanding core engineering and product development team and looking for high caliber, senior software developers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment.

Responsibilities include: Being involved in all stages of SDLC including analysis, design, implementation, testing, documentation, and release; Participate in multiple projects with changing requirements; and Maintain contact with clients/ partners to provide solution support and updates.

Requirements include: 4-6 years of software development experience; Software Development experience; ASP.NET with MVC, JQuery; Comfortable in data modeling, developing stored procedures, and triggers; and Readiness to learn new technologies quickly. Windows Workflow Communication Foundation 4.0; Biztalk RFID server skills; Windows Mobile Development experience; and Exposure to Windows Azure.

The position is located in the San Francisco Bay Area. Telecommute is okay but may need to attend client team meetings. Duration: 6-12 months to full-time. Terms: 1099, corp-to-corp, contract-to-hire, no visa sponsorships. Pay: rate negotiable. Open to considering excellent part-time candidates.

Program Manager – Santa Cruz, CA

A contract manufacturing company, near South San Jose, has an immediate opening for Program Manager.

Responsibilities: Managing the processes by which the company designs, develops, tests and releases for production the tooling, assemblies, equipment, and facilities required to meet customer needs; Act as primary focus for NPI for customer products, directing development and transfer to manufacturing; Supporting the Sales Department in the technical aspects of new business development and customer relations; Supporting the Manufacturing Department to resolve design issues impacting the manufacturing process; Supporting the Quality Department to diagnose and document the root cause of unacceptable product and process variation; Participating in the management of the company as a member of the Management Team.

Responsibilities also include: Take charge of projects assigned and charts status; Drive customer project requirements, reporting the customer needs to management; Lead cross-functional resources, organizing a productive, capable, and skillful project team with Manufacturing, Quality and Sales; Lead vendor qualification of machine parts with purchasing; Drive customer expectations.

JOB DESCRIPTION Program Manager; Develop trusting relationship with customer; Balance company goals with customer expectations, knowing when to push back; Support operational excellence (OE) and 5S programs; Recognize problems and eliminate them before they become crises; Track costs in labor, materials and resources with precision and accuracy; Preparing and submitting billing data to the Accounting Department; Report project problems to management; Collaborating with the Sales Department to develop new equipment and facilities that will meet customer objectives; Collaborating with the Quality Assurance Manager to develop process definition, measurement and improvement for newly developed tooling; Supporting the Manufacturing Manager in the selection of manufacturing materials, manufacturing equipment and control.

Requirements: Undergraduate degree in an engineering or technical discipline; Relevant experience may be substituted for the educational requirements; Five to ten years substantiated experience in the engineering function with companies that provide highly sophisticated manufactured products; Experience in the medical, bio-technology and other high technology industries strongly preferred; Experience in dealing with customers is strongly preferred; Must demonstrate expertise in a variety of concepts, practices and procedures common to the manufacturing industry; Project a neatly groomed, confident appearance and be effective with public speaking and direct client interface.

The environmental conditions in which the Program Manager will perform his/her duties are an open office. This position will require visits to client sites in all types of weather. The normal travel hazards will apply including driving and flying in a variety of traffic and weather conditions.

Other Requirements: The physical demands of the position are listed in accordance with the requirements of the American with Disabilities Act. They are outlined on the attached Checklist: Good reading, writing and verbal skills to communicate clearly and effectively in the English language to customers and company personnel; Intermediate capability in engineering and project management software; Computer literate in Word, Excel and Power Point with full competency in sourcing Internet material; Ability to maintain a flexible work schedule to meet the demands of the job. Some evening and weekend work may be required; High tolerance for stress and deadlines

Performance Criteria: The Program Manager’s performance is satisfactory when the following have occurred: New programs have been completed to the satisfaction of management and the customer; Responses to Requests for Quotes are submitted to the Sales Department when committed; The management team is always informed of the status of new programs; Billing information is submitted to the Accounting Department in time to support the billing process; Required reports are accurate and submitted on time.

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Pharmacologist with Large Animal Survival Surgery Experience: San Jose, CA

A dynamic company, founded by a veteran leader, involved in the development of drug-device combination products for treating chronic diseases, has an opening for a Biologist. This is once in a lifetime kind of an opportunity to work on exciting technology with game changing potential. The candidate must have hands-on research experience including in vivo experience esp with large animal models during their doctoral and post-doctoral training period. The ideal candidate will have a Ph.D. in Physiology/Pharmacology or any other related Biology discipline or a DVM with research experience. The individual is expected to have a breadth of experience in both in vitro and in vivo biological research supporting various drug/ device development programs across multiple therapeutic areas including CNS, oncology, cardiovascular and metabolic diseases.  The individual will support and work with external institutions including CROs and academic institutions especially for conducting in vivo studies in small as well as large animals. Additionally the individual will set up and run a variety of routine in vitro research paradigms in house as needed such as isolated tissue and cell-based assays as well as quantitative assays for small molecules, peptides and proteins using techniques such as FTIR, HPLC, and immunoassay. The individual will work with a multidisciplinary team of experts and provide biology support with minimal supervision on various ongoing projects.