Please see some of my current opportunities below. All opportunities are for local 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 underscore darshana at hot mail or find me on Linkedin.
Manufacturing Engineer – San Jose, CA
Summary: Supports the manufacturing of high volume disposable device. Works with engineering and clinical to make sure device specifications conform to device requirements. Works with assemblers and technicians to make sure devices are built to desired specifications.
Responsibilities
- Evaluate manufacturing processes by designing and conducting research; apply knowledge of product design, fabrication, assembly, tooling, and materials; solicit observations from operators.
- Evaluate manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
- Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
- Assure product and process quality by designing test methods; establishing standards; testing finished product and process capabilities.
- Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
- Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
- Work with Development Engineers to effectively transfer new products to Manufacturing.
- Maintain product and process data.
- Complete design and development projects by training and guiding technicians and assemblers.
Requirements:
- Proficient in process validations and its execution
- Contribute to team effort by accomplishing related results as needed.
Education and/or Job Experience
- Bachelor’s Degree in Engineering Field or equivalent
- Minimum 15 years in Medical Device Industry
Skills and Specifications
- A proven track record with Medical Device Manufacturing Methods and Procedures and FDA QSR 21 CFR Part 820 and ISO 13485 Quality Systems
- Capable of generating parts, assemblies and drawings using Solidworks
- Comfortable dealing with complexity and flexibility
- Experience working under Change Control policies of FDA regulated devices and /or drugs.
- Ability to proactively identify and solve manufacturing issues.
Senior Manufacturing Equipment Engineer – San Jose, CA
Summary: Supports the manufacturing equipment and tooling used to manufacture company’s proprietary high volume disposable device. Works with Calibration and Preventive Maintenance personnel to ensure equipment is kept in optimal conditions. Works with equipment suppliers/vendors to purchase equipment/parts under our or equipment specifications.
Responsibilities
- Assures that equipment integration projects are performed under the required timelines and budgets.
- Develops manufacturing equipment by designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling, and materials; soliciting observations from operators.
- Identify Capacity and Quality Issues with Manufacturing Equipment. Recommend and Implement Solutions to revolve issue.
- Provides support and oversees maintenance on Production Molding Machines
- Design and fabricate of tools and fixtures with In house Machine Shop Equipment
- Keeps equipment operational by coordinating maintenance and repair services; following manufacturer’s instructions and established procedures.
- Proficient in developing IQ/OQ/PQ documentation and its execution
- Maintains product and company reputation by complying with government regulations.
- Contributes to team effort by accomplishing related results as needed.
Education and/or Job Experience
- Bachelor Degree in Engineering Field or equivalent
- Minimum 15 years in Medical Device Industry
- Experience in plastic molding and material analysis
Skills and Specifications
- A proven track record with Medical Device Manufacturing Methods and Procedures and FDA QSR 21 CFR Part 820 and ISO 13485 Quality Systems
- Capable of generating parts, assemblies, and drawings using Solidworks
- Comfortable dealing with complexity and flexibility
- Experience working under Change Control policies of FDA regulated devices and /or drugs.
Business Analyst – Pleasanton, CA
Requires 2+ years experience. Company offers 100% healthcare coverage & other benefits like 401K and there is potential for bonus.
Associate Scientist – Pleasanton, CA
Requires 10+ years pharma R&D experience with expertise in cell biology and should be able to translate it into business. Must know industry well and have a good network.
Regulatory Manager – San Jose, CA
Requires 8+ years of experience in pharma, ideally experience in biologics.
Clinical Trial Manager – San Jose, CA
Ideal experience: 8+ years experience in medical devices, ideal in neuromodulation, running clinical trials, working with clinicians and medical centers.
Clinical Trial Manager – San Jose, CA
Ideal experience – 8+ years of hands on experience in running pharma trials at manager level. Running clinical studies in biologics is a major plus.
Director of Manufacturing Automation – San Jose, CA
This position requires a dynamic, energetic, self-driven, engineering leader with broad manufacturing engineering and automation experience & will report to VP of Manufacturing Operations. The Director of Manufacturing Automation will lead the development of fully automated manufacturing systems for all aspects of company’s disposable drug tablet manufacturing. This individual will be responsible for defining system requirements, developing proof of principle systems, developing timelines and managing budgets and providing direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. This individual will work closely with product development, manufacturing engineering and quality in order to ensure manufacturability, achievement of targets, and develop processes for optimum manufacturability.
Responsibilities: Define functional & detailed requirements & specifications for manu automation, including quality & regulatory requirements; Manage internal & external process automation programs, project schedules & budgets; Develop facility plans & specifications for manufacturing scale-up; Oversee installation & qualification of automated manu systems; Comply with USFDA cGMP regulations, (ISO), Company policies, operating procedures, processes & task assignments.
Requirements: Experience managing and leading complex cross functional projects involving, electrical, mechanical, quality aspects; Experience with mechatronics or automation engineering including machine, mechanism and fixture design; Strong problem solving and analytical skills; experience with use of statistical analysis & design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation. This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome. BS/MS in Mechanical, Electrical or Industrial Engineering & 15+ years’ experience managing an engineering group responsible for medical device development and manufacturing engineering with a strong history of hands-on experience is required. Also required Deep expertise in manufacturing automation for large scale manufacturing.
Director of Pilot Manufacturing – San Jose, CA
Innovative medical device company located in San Jose, CA has an immediate opening for Director of Pilot Manufacturing. This position will report to VP of Manufacturing Operations. This low volume production line is crucial to the company’s several ongoing preclinical studies.
Duties and Responsibilities
Lead day to day operations including injection molding, aseptic processing, capsule assembly, supply chain and other related activities; Develop detailed production planning, resource allocation, equipment maintenance, operator training etc.; work closely with product development, pre-clinical & clinical groups and quality in order to ensure achievement of targets & develop manufacturing plans & detailed production schedules; Manage inventory of raw materials & injection molded components; Manage human resources in pilot manufacturing; Maintain a strong commitment to quality; Comply with U.S. Food and Drug Administration (FDA) cGMP regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.
Requirements
Strong problem solving & analytical skills; Experience with use of statistical analysis & design of experiments for product optimization and validation activities; Experience with lean manufacturing, design for manufacturing, design for test & test implementation; Experience working with ERP systems & Broad GMP manufacturing background with Class III medical devices. Requires BS/MS in Mechanical, Electrical or Industrial Engineering and 15+ years’ experience managing & supervising manufacturing with a strong history of hands-on experience successfully transferring new products into manufacturing & Deep technical experience with manufacturing processes, design control and quality systems. Also required, strong problem solving and analytical skills; Experience with use of statistical analysis and design of experiments for product optimization & validation activities; Experience with lean manufacturing, design for manufacturing, design for test and test implementation; Experience working with ERP systems. Also essential is proven ability to coach & develop employees & develop effective cross functional relationships. This position requires interface throughout all levels & functions of the organization.
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