Posts Tagged engineers
R&D Engineer w/ Analytical Instrumentation, Systems Integration Exp – Sunnyvale, CA
There are several exciting opportunities for product development research associate/ technician/ engineers in developing, testing, optimizing and troubleshooting aspects related to novel diagnostics technology platform & to work with novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. The compensation will be competitive and includes stock with a huge potential as well as competitive benefits package. Company is found by a veteran leader and focuses on development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. This role requires working with a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.
Testing, development and optimization of functional biochips, fluidic cartridges & analytical instruments; Support document prep; Use Good Documentation Practices (GDP) while authoring Experimental summaries, DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations; Process development & optimization related to biomolecular sensing; Support all aspects of technology transfer to & from development partners; Develop, test & execute QC procedures; Process troubleshooting to determine root cause & find possible engineering solutions.
Requirements: MS in bio-, mechanical-, electrical- or chemical engineering, chem or biochem, or related; 5+ years hands-on R&D, engineering or product development and project/ people management experience. Experience in developing custom equipment by collaborating with external vendors or internal engineering resources; hands-on experience in mechanical design and in building & operating electronic systems; Proficiency in CAD design; Experience w/ statistical analysis software as well as with instrument-oriented programming language(s) (e.g. Python; LabView); Experience with standard biotech laboratory and/or manufacturing equipment & working with biological or biochemical systems (e.g. proteins, nucleic-acids, cells and/or bio-organic molecules); Experienced using diverse analytical instruments e.g. oscilloscopes, DAQ interfaces; Experienced in cGMPs & in authoring DOPs, BRs, FRs; Experience in V&V of instruments and processes; and Knowledge of data analysis methods.
Optics & Photonics Research Scientist/ Engineer w/ microfluidics/ lab-on-a-chip Exp – Sunnyvale CA
This is an exciting opening for interdisciplinary research scientist/ engineer with experience in photonics, material science and/or biological applications product development to work in multi-disciplinary team, in developing, testing, optimizing and troubleshooting aspects related to novel diagnostics technology platform & to work with novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. The compensation will be competitive and includes stock with a huge potential as well as a competitive benefits package. Company is founded by a veteran leader & focuses on development & commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.
Responsibilities: Support optofluidic platform technology development, & development of single-molecule detection technology with novel reagents & fluidic cartridges, as well as instrumentation for detection, sample preparation & corresponding software; Support diverse aspects related to mid-stage development of a bio-chip based, optofluidic diagnostics platform; Apply diverse knowledge of design principles, practices & implementation in complex systems & assignments; Design, optimize, test, & support validation of optofluidic chips, optical/fluidic interfaces, sample processing technology & instruments, in collaboration with other groups & external suppliers; Develop, evolve & maintain custom optoelectronic systems used for testing and characterizing optofluidic systems; Analyze & present data including images, time traces, assay flows, optical spectrums; Conduct statistical analysis & build/implement/test models for stochastic, high-volume data; Support all aspects of technology transfer to and from internal and external partners; Interface with internal resources and external vendors to design, test & validate equipment.
Requirements: BS/ MS in bio-, mechanical-, electrical- or chemical engineering, chemistry, physics, biochemistry, or related plus 1-5 years hands-on R&D or engineering experience; Extensive theoretical and hands-on experience in optics/photonics; Experience bridging the fields of photonics/optical engineering, microfluidics/lab-on-a-chip & statistics; Exp in design of optical systems (free space & chip based) & in using simulation software eg. ray tracing software for system design & FEM/FDM/BPM etc for chip design: Proficiency in statistical analysis (e.g. Python, JMP, Matlab, etc.) as well as instrument-oriented programming language(s) (e.g. Python; LabView); Experience in using diverse, analytical instruments such as oscilloscopes, DAQ interfaces, UV-VIS spectrometers, scanning electron microscopes (SEMs), fluorescence microscopes, etc. Expertise in optofluidics, Hands on ability to work-with/manipulate/couple optical fiber and respective components, Proficiency with digital/analogue signals & systems; Experience simulating in Multiphysics environments (e.g. Comsol, Lumerical) and Circuit design and simulation experience are all HUGE PLUSES.
Finally, ONLY CANDIDATES PROVIDING A POSITION SPECIFIC COVER LETTER WILL BE CONSIDERED!
Software Engineer w/ experience building products in multi-disciplinary envt – Santa Clara, CA
This is an exciting opening software engineer with experience software & hardware development to design, develop & implement a growing suite of bioanalytical solutions comprised of integrated biochips, proprietary reagents & custom instrumentation. The company is founded by a veteran leader and is developing single molecule detection technology, and is focusing on development & commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications.
Responsibilities: Lead / Support Software, Firmware & UI development aspects related to the development of novel, diagnostic instrument platforms; Develop control/analysis software for RUO (Research Use Only) & FDA regulated instrumentation; Develop / Contribute to a custom user interface for scientific & medical diagnostic systems; Support all aspects of technology transfer to & from internal & external partners; and work with a multidisciplinary team of experts.
Requirements: B.S. with 3+ years of relevant experience (Level I), B.S./M.S. with 7+ years of relevant experience. (Level III). Requirements also include, Significant experience with instrument-related software engineering using C#; Experience with Python programming; Exp w/ industry coding best practices (Git management, unit testing, documentation, etc; Experience developing, implementing, consuming & supporting contracted APIs. Also preferred: Experience with interface standards (e.g. GraphQL, OpenAPI, etc.); Experience with firmware level interaction (e.g. C). Experience with delivering quality conformant software (e.g. SaMD); Experience with complex data analysis challenges; Ability to develop custom equipment with external vendors and/or internal engineering resources.
Finally, ONLY CANDIDATES PROVIDING A POSITION SPECIFIC COVER LETTER WILL BE CONSIDERED!
Senior Manufacturing Engineer – S. San Jose, CA
Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development has an immediate opening for senior manufacturing enginee, to support the development and production of innovative catheters ensuring high reliability, regulatory adherence, and cost-effective manufacturability.
Requirements: Minimum 10 years history of experience in medical device manufacturing environment; Proficiency in Solidworks; Experience writing protocols & test reports; Experience using inspection and test equipment (vision systems, tensile testing) are required.
Responsibilities: Support manufacturing activities; Spend time on the manufacturing line with the assemblers to improve processes & increase quality; Develop assembly & test fixturing; Create, validate & document new manufacturing processes; Write protocols & test reports; Prepare manufacturing lines for significant scale up; Conduct process verification & validation activities; Initiate failure analysis in manufacturing; Design, write & perform equipment qualifications & process validations; Facilitate transitioning development products to full scale production line; Collaborate with existing suppliers & bring up new ones with an eye towards partnership & efficiency.
Associate Director/Director Validation – SJ /QUALITY – QA TEAM
There is an immediate opportunity for Director of Validation in San Jose, CA in a pharmaceutical company with novel drug delivery technology. The company recently had an IPO event and the stock has held very well and the technology holds promise to be a game changing improvement in the quality of care for many patients. The company has a world class team in place. Director of Validation is a hands-on role responsible for the execution of validation activities: To develop & implement harmonized validation processes & practices; Develop a qualified team; Manage validation/qualification of equipment, facilities, utilities, cleaning, sterilization, automated systems, and computer system validation in a cGMP environment.
Skills & Experiences:
Responsibilities: Ensure development & implementation of validation strategies & internal SOPs; Write & review qualification & validation documents; Lead & support qualification & validation of cGMP equipment, facilities, utility systems, cleaning & manufacturing processes; Develop & maintain risk based, quality driven procedures & practices; Lead risk assessment activities; Identify, hire & develop, manage & support company’s validation expertise; Support change control program with respect to facility, utilities, equipment, cleaning & computerized systems validation changes; Evaluate validation impact of manufacturing process changes & equipment upgrades; Complete activities related to regulatory filings, production schedules and/or customer needs with respect to facilities, utilities, equipment, computer system validation, etc.; Ensure Quality meets or improves on budget, cost & efficiency targets (KPI’s) in line with business objectives; Support QA activities related to the assigned projects, including, but not limited to: internal and external audits, deviations, change control and CAPAs; Other duties/activities may be necessary to support departmental or company goals.
Skills & Experience: BS in life science or engineering; 10+ validation exp in bio/pharma industry; 5+ years of supervisory/managerial experience; Knowledge Good Engineering Practices, FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971) & validation such as GAMP 5, 21 CFR Part 11, and ASTM E2500; Knowledge of international & domestic cGMP regulations for pharmaceutical manufacturing; Technical writing, problem solving & analytical skills; Ability to review, analyze, summarize & interpret data, draw conclusions & make decisions/ recommendations; and Experience in project management.
Quality Assurance – S. SJ
There is an immediate QA position available for support & performance of QA/QS functions/activities and adherence to applicable regulatory standards for medical devices. This is a vascular company founded by a seasoned entrepreneur whose previous company had $1B+ exit. This opportunity will offer competitive salary plus stock with huge potential.
Skills & Experience Required: BS in Science related area; 10+ yrs experience in FDA regulated industry; Exp with Quality Assurance practices & systems; Knowledge of ISO 13485 and FDA 21 CFR 820; MasterControl administration/process ownership; Maintain compliance of a certified QMS related to configuration control, document control, and change control. ASQ Certifications are a plus.
Responsibilities: Support devet & maintenance of QMS, ensuring alignment of corporate operations applicable regulations; Serve as system administrator for MasterControl Electronic Document Management and Training System (EDMS), including responsibility for configuration, user training, account management, training course creation and assignment & assessment of upgrades & patches. Maintain validated state of system throughout system lifecycle. Manage, process & track controlled documents from the Document Change Order (DCO) process until document approval or retirement, including updating related controlled documents; Revise controlled documents as appropriate & ensure timely reviews. Manage electronic approval of records/documents via DocuSign; Monitor & track completion of quality system records including CAPA, Deviation, and NCMR; Monitor training compliance & report any issues to management; Maintain Approved Supplier List (ASL) and ensure supplier files are current; Perform raw data review in support of technical reports and regulatory filings & Issue, track, and perform quarterly audits of laboratory notebooks. Assess corporate operations against quality system regulations, issue identification/ resolution including proper and timely documentation; Prepare quality metrics & reports; Facilitate & conduct internal & external audits; Perform history record review & disposition of device batches. Review/approve facility records as needed (pest control reports, cleaning logs, and environmental monitoring reports & Manage archival of hard-copy records.
Senior Manager CMC, Analytical Development – North San Jose, CA
There is an exciting job opportunity in San Jose, CA, to work on novel projects involving drug-device combinations for treating chronic diseases & participate in method and tech transfer from R&D to Manufacturing as appropriate. This is an exciting opportunity in a rapidly growing company to work with a world class team, on game changing technology with HUGE potential.
Requirements include: BS/MS in sciences PLUS 5+ years relevant bio/pharma experience; biologics analytical development exp in biophysical techniques & analytical characterization of peptides & proteins; solid oral dosage and/or parenteral sustained release formulation exp, exp in process development from early to late phase development; experience of working in GLP/GMP regulated environment, drug-device combination exp; knowledge analytical techniques such as various HPLC modes & detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell-based assays, etc, for product characterization, comparability testing and PK/PD analyses; Exp in method validation and specification setting; Assessing chemical & physical stability of formulations, identifying stability, manufacturability, & performance critical quality attributes. Experience in protein purification & biologic formulation is a plus.