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.
Project Manager – North San Jose, CA – hot
There is an exciting opportunity for Project Manager to lead the successful execution & launch of engineering projects in a fast paced environment. This position has responsibility for daily management of complex projects & requires a high degree of coordination with a cross-functional team.
Responsibilities: Oversee & drive multiple engineering projects from initiation through validation & product release; Develop realistic project schedules w/ resource plan, risk mgmt, & measurable metrics; Communicate progress & coordinate interdependent tasks & deliverables w stakeholders; Lead meetings, plan agendas, presentations & action items and deliverables; Comply w/ company policies on design control & validation activities & documentation.
Requirements: BS in engineering or related; 7-10 yrs exp w/ managing engineering projects & standard project mgmt methods, tools & software packages; strong people & negotiation skills, leadership skills, self motivated, adaptable, flexible, creative, strong technical problem solving abilities; Able to handle multiple projects w/ organizational & time mgmt; Fluency w/ Excel, Word, PowerPoint & Visio; Proven track record w/ medical device, FDA regulations, ISO, cGMP & QMS standards; In-depth understanding of V&V (IQ, OQ, PQ & risk analysis (FMEA). Preferred: PMP certification, Exp w/ Visual Project Mgmt; Exp w/ turnkey, capital equipment; Familiarity w/ sterilization process & aseptic manufacturing.
Director of Regulatory Affairs – North San Jose, CA hot
There is an exciting opportunity for Director of Regulatory Affairs in a drug delivery company in San Jose, CA that is responsible for development of global regulatory strategy, managing RA activities (nonclinical & clinical), for investigational drug-device combination products from preclinical through product approval & RA submissions.
Functions: Develop & execute regulatory strategies for earliest possible approvals; Help translate local, regional & international regulatory reqs in workable plans; Plan strategy for product registration & submissions to health authorities worldwide; Interact cross-functionally; Prep filings of INDs, CTAs, BLAs, NDAs, MAA etc.; Exp in CMC regulatory compliance; Review clinical trial documents, protocols, reports, brochures, Review & approve clinical manufacturing plans & labeling & authorize drug shipment to clinical sites; Liaise w/ regulatory agencies for review & approval of plans, timely resolution of issues & approval of marketing; Manage regulatory timelines; Interface w/ international affiliates; Maintain knowledge of global competitive landscape & regulatory environment.
Requirements: BS or MS in a scientific discipline, 10-15 yrs exp in RA in biotech or pharma, Knowledge of drug device combination products and exp in global regulatory strategy & submissions, Exp in multiple phases of devt in various therapeutic areas, Exp w/ biologics (this is a must); Ability to travel.
Quality Engineer – North San Jose, CA
There is immediate opportunity for Quality Engineer in well funded startup by a veteran leader with a world class team. JD will be posted soon but meanwhile please send CV.
Quality Engineer – South San Jose, CA – urgent
Exciting bay area start-up on catheter development to focus on improved outcomes of arterial disease has an immediate opportunity for Quality Engineer.
Support QA/QC/QS functions and activities in a medical device manufacturing environment; Establish purchased materials RI acceptance criteria & perform RI; In-process/final device inspection; Technical Writing for Design History File documents etc, Regulatory & Quality System documents; Design, write & perform equipment qualifications & process validations; establish & maintain equipment calibration & maintenance; support team, contract manufacturers & suppliers with robust & statistically valid testing, sample size selection, monitoring & analysis requirements
5+ years medical device work experience (vascular catheter exp preferred), formal statistics training, Validation protocol design & report writing exp, exp to work in & maintain compliance of a certified QMS related to configuration control, document control & change control, enthusiasm for producing cool new products for catheter development. College education preferred.
Bioanalytical Lab Research Scientist – San Jose, CA – hot
This is an exciting opportunity for a bioanalytical scientist to join world class team to work on drug-device projects, with the potential to dramatically change patient outcomes. Position, salary, and benefits are commensurate with experience, with possibility of option grants!!
Required: Background in medical device or pharma testing & regulatory development. Experience in preclinical and clinical research is a must. The candidate must have technical training in biochemistry and/or pharmaceutical sciences with experience using lyophilization, Karl Fischer titration, and HPLC. Experience with biochemical analysis such as spectrophotometric and fluorescence immunoassays, and LC-MS is a plus. Also required, degree in biochem or pharma sciences w. 2+ years experience, extensive exp in various analytical techniques & bioanalytical assays.
Responsibilities: Lead projects on biologic formulation, drug product process development; Executes experiments based on protocols and implement; Develop & maintain documentation, test methods, study protocols, SOPs, worksheets, forms, and reports; Design and manage data from complex experiments including preliminary statistical analysis; literature searches; Maintain lab & assay operations notebook, equipment, supplies, computer files; Support regulatory efforts.
Bioanalytical Lab Scientist – San Jose, CA – urgent
There is an exciting opportunity for a bioanalytical scientist to join a team working on drug-device combinations projects w/ potential to change patient outcomes. Attractive benefits package with competitive salary is offered and option grants makes this exciting opportunity. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment.
Responsibilities: Perform bioanalytical assays for the quantification of the analytes in in-vitro, preclinical and clinical samples; Participate in the development of in vitro/in vivo models by performing a variety of microplate assays independently with minimal supervision; Configure, program and troubleshoot laboratory automated platforms; Optimize existing automated processes to improve efficiency, throughput, robustness and quality. Perform literature search, routine data management, tabulate & graph results, support regulatory efforts & manage lab supplies, safety, equipment.
Required: Background in medical device or pharma & exp in preclinical and clinical research is a must. Also required, background in biochemical analysis such as spectrophotometric, fluorescence immuno assays, HPLC, CE, LC-MS. exp w/ microplate assays is must and experience with Luminex MapX technology is a plus. BS + 3 yrs work exp or MS + 1 yr exp and exp in writing reports & SOPs, knowledge of statistical software like Excel, GraphPad, Prism & Softmax Pro and hands-on exp in automation & liquid handling in a bioanalytical lab is required.
Senior scientist role requires 5+ years work experience.
Senior Scientist/ Dir/ VP – S. San Francisco, CA – urgent
Senior Scientist/ Director/ VP (commensurate with experience)
An early stage biotechnology startup with patented technology for engineering mammalian cells to vastly increase productivity for therapeutic proteins & disrupt biologics manufacturing, has two exciting openings. (The company has backing from J&J).
Job Functions: The work will involve vector design & preparation, transfection, cell culture, cloning & screening, flow cytometry & other related molecular and cellular biology techniques. Collaboration with co-workers & pharmaceutical company customers is essential for this position.
Requirements: Candidate is required to have Ph.D. plus multiple years of experience with cell line creation, mammalian cell culture expertise, know regulatory landscape related to creating & testing cells for GMP manufacturing; exp. with molecular biology techniques for creating vectors & transfecting cells: exp with protein assays, with a goal to further develop the technology toward full commercialization. Experience with flow cytometry, cell banking, transposase transfection methods a huge plus.
There is immediate opportunity for Manufacturing Engineer in San Jose, CA, in a well funded startup by a veteran leader with a world class team. JD will be posted soon but meanwhile please send CV.
Senior & Junior Mechanical Engineers – San Jose, CA
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 – urgent
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.
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.