Posts Tagged R&D
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on December 22, 2014
Tim Pelura, CEO, Surpass Preclinical CRO talked on how medical device companies can align their strategy, from preclinical to market, with a focus on the value proposition, at www.bio2devicegroup.org event.
We are operating under a new reality now where power has shifted to the payers and the providers, said Pelura. Medical device companies are evaluated based on safety and procedural efficacy as well as cost and value. Increasingly heightened regulatory scrutiny and tightening FDA regulations have led to increase in audits (which were up 40% in the last year) and warning letters are (which were up 24% over the last 2 years). Due to regulatory and reimbursement challenges, medical device companies are focusing their R&D efforts on improving already approved devices, rather than developing innovative new products. Meanwhile startups are finding the landscape challenging due to funding challenges and increasing costs of bringing new products to market.
Inkeeping with the reality of pressures on payers that are transmitted down, new healthcare delivery models are emerging, and therefore, patient pathways are being modified to obtain to obtain better outcomes, with less cost. Medical device companies will need to work with new business models, that solve significant problems and reduce overall costs. Companies seeking growth will need to expand their offerings to target underserved populations and lower socioeconomic classes.
In essence, it is about the value proposition offered by the new product or service, “what benefit you provide for who and how you do it uniquely well”, said Pelura. He advised, these “must-haves” in a business pitch, “describe your target buyer, the problem you are seeking to solve, and why you do it better than the alternative”.
Pelura walked the audience through the process of arriving at the value proposition. First, companies must define the problem they are seeking to solve and identify correctly the need to solve the problem. Next, they should try to go after obvious problems, rather than aspirational or “good to solve” problems. And finally, they should try to address acute or critical problems.
In defining a solution, they should try to generate many ideas and then measure the viability of customer adoption of each idea using gain/pain ratio; what the customer stands to gain versus the cost of adoption of the new solution. The best solutions are those that offer game-changing benefits, with minimal modifications to the existing process or environments, said Pelura. Go for “Disruptive Innovations, that are Non-Disruptive to Adopt”, advised Pelura. Medical device companies must visualize the entire process or patient pathway to ensure that the new solution would cause minimal disruptions, in the whole process.
While new technologies often emerge with a focus on engineering and progress to bench testing and then plan preclinical, and clinical strategies and only then consider navigating regulatory, market, and reimbursement challenges; in actuality, they should invert the process. They should begin with considering reimbursement challenges, analyze the competitive landscape, study the market opportunity, give thoughtful consideration to the regulatory challenges, then consider clinical and preclinical strategy, before embarking on prototype and bench testing. Because if the value proposition is wrong then a company can end up with a product that no one wants or needs, resulting in considerable waste of precious innovation dollars and time, said Pelura.
Speaking of Surpass, Pelura shared that preclinical Contract Research Organization, Surpass is doing things differently. While having deep expertise as a preclinical CRO in helping medical device companies with their preclinical in vivo and human cadaveric studies, Surpass also seeks to impact the system, by probing and assisting their clients with questions that go to the value proposition. Surpass assists the clients in designing the most translatable preclinical study by understanding issues of clinical end points, product’s desired features and characteristics, all the while keeping in mind who would be operating the device, studies and activities that might need to be completed to demonstrate the products, performance, safety, and efficacy, as well as data that would be required to drive reimbursement and more. This novel process ensures that any preclinical testing performed is aligned to the new product’s value proposition, hence helping save valuable healthcare innovation dollars.
The session was followed by Q&A.
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 (except the first one which is located in Taiwan). Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled. I am awaiting more job descriptions and will keep adding. Leads appreciated.
Director of Laboratory Operations – Taipei, Taiwan
Reports to General Manager
An early stage company revolutionizing early cancer detection and prevention, bringing a superior quality of life, has an immediate opening for Laboratory Manager/ Director in Taipei, Taiwan. With its simple, accurate, and proprietary blood test, the company’s vision is to screen every person in the world. The technology was developed by scientists from Stanford University’s Genomics Research Center in Taiwan. The company has offices in Silicon Valley (U.S.) and Taiwan, and is funded by a leading venture capital firm in the U.S. and prominent technology industrialists in Taiwan. This position is currently located in Taiwan.
Summary: This is a key position, required to manage and run a clinical laboratory currently being established in Taipei, Taiwan. The position reports to General Manager. The Director of Laboratory Operations will have sole responsibility for all aspects of running the company’s Clinical Laboratory. S/he will plan, organize, schedule, and direct work in order to effectively maximize the Laboratory’s employees, equipment, and materials utilization within budgetary constraints while adhering to quality technical standards. This individual will provide direct on-site supervision of specimen workflow, test performance, operations, clinical report generation, quality, compliance, and associated documentation to adhere to company policies and procedures and Taiwan Ministry of Health and Welfare Regulations.
Responsibilities: Manage the day-to-day operations; Ensure all lab policies & procedures meet the standards of current applicable lab regulations in Taiwan, & ensure compliance through documentation, audits, & corrective action; Develop & implement plans for initial lab set up, expansion to accommodate growing volume, & for validating new tests. Perform and/or delegate the scheduling, planning, staffing, and monitoring of workflow to meet established goals; Maintain adequate staffing by interviewing, hiring, training, and assessment of personnel; Provide staff development through performance development and review; Support, implement, and ensure compliance with all company policies and procedures. Direct updates of laboratory standard operating procedures and databases to accurately reflect the current practices; Procure appropriate supplies and equipment to maximize efficiencies and to meet established budgetary and quality goals; Maintain equipment and instruments in good operating condition, recognizing any malfunctions and troubleshooting as needed; Provide technical oversight and serve as a technical supervisor for problem solving and process improvements in order to ensure accurate test performance and to maintain adequate workflow; Work as needed with Research and Development on new projects and for technology transfer; Monitor and ensure implementation of goals to meet established quality assurance, quality control, and quality improvement plans; Ability and willingness to follow all laboratory procedures; Ability and willingness to act in accordance with regulatory compliance requirements, including but not limited to company’s quality system requirements
Qualifications and Experience Required: Registered Medical Technologist in Taiwan. 10+ years of experience as a Medical Technologist or equivalent in a clinical laboratory environment, including supervisory/management function; BS/BA degree in Medical Technology or related field; Word processing, statistical/data management skills required; Must have proven leadership and interpersonal skills. Excellent oral and written communication skills required. Fluency in Mandarin and working knowledge of English; Familiarity with Taiwan Ministry of Health and Welfare Regulations, patient privacy protection regulations, and ISO 13485 requirements; Familiarity with ISO 15189 and 17025 desirable.
QA Testing Manager – Mountain View, CA
There is an immediate opening for QA Test Manager at remote health startup that is focused on bringing diagnostics into home use, with a vision to change healthcare.
Responsibilities: Define and manage validation and verification processes for medical devices; Analyze validation & verification needs, determines effective strategies & resources, & implement needed processes; Ensure that all work adheres to applicable SOPs, standards & regulations; Take responsibility for forming & maintaining the V&V team and directing the preparation & execution of all work. Requirements: Bachelor’s Degree in a technical field, Biomedical Engineering, Electrical Engineering, Computer Engineering or Computer Science preferred; At least 3 years experience testing against product requirements and tracing tests to product requirements; At least 3 year experience working with design engineers, software, electrical and mechanical engineers and external and internal customers; Experience in working with engineers to design for testability; Experience managing short-term or outsourced testing resources on-site or off-site; Possess requirements & technical documentation preparation & analysis skills; Strong communication, analytical & interpersonal skills. Preferred: Master’s Degree: Biomedical Engineering, Electrical Engineering, Computer Engineering or Computer Science preferred.; Expert in creating, managing, and executing test plans, procedures, and scripts; Expert in manual, automatic, regression, blackbox, whitebox, boundary condition, performance and other standard testing methods; Experience working with manufacturing team; Experience using a requirements and test management software system; Experience in leading a V&V team.
Director Quality Engineering – San Jose, CA
There is an exciting opportunity for Director Quality Engineering with strong capability and experience developing quality innovative medical devices. This position is responsible for effectively leading multi-project quality engineering efforts of the organization through technical expertise, interpersonal skills and a clear vision for execution.
Responsibilities: Manage resources to accomplish multi-project product research, development and manufacturing; Contribute to strategy and management of GMP/GLP operation; Provide Quality Engineering support as necessary to meet organizational objectives; Maintain quality management systems necessary for development, including clinical evaluation; Develop quality plans and data analyses for execution and review with leadership team; Develop test strategies DOEs and test protocols to test developmental medical devices and manufacturing processes; Work with R & D and Operations to establish quality requirements at all phases of product/process development and manufacturing; Design, schedule, and if necessary, performs specific testing for existing and new products including supporting design and process validations, qualifications and first article inspections; Conducts supplier evaluations including supplier audits; Ensure that appropriate level of quality/reliability in purchased components is specified; Identify product/process problems and ensure appropriate corrective actions are taken and verified to be effective in eliminating problem; Remain current on developments in field(s) of expertise and industry trends; Mentor junior staff members
Skills Required: Demonstrated leadership of technical teams in medical device field; Demonstrated aptitude for and mastery of Quality Engineering principles; Demonstrated problem solving skills in a multidisciplinary environment; Exemplary analytical, organizational, written and oral communication skills; Proficient with statistical analysis for engineering and manufacturing; Strong ability to operate independently and as a team member; Teamwork: ability to work closely and effectively with team members and colleagues across engineering as well as non-engineering disciplines such as biochemistry, physiology, pharmacology and chemistry; Knowledge of implantable medical device design control and manufacturing processes ; Deep experience in safety standards for a variety of medical device types; Knowledge of biocompatibility, packaging and sterilization quality assurance; Demonstrated ability to interface effectively with professionals in the medical and biological sciences; Demonstrated knowledge of sound design principles, regulatory requirements, and product and process validation procedures; Demonstrated proficiency with computer aided design software and hardware familiarity. Formal training on systems and software is desired.
Also required: Bachelor’s degree or higher in Engineering; Ten years minimum experience in medical device engineering (Quality, R&D and Manufacturing) with demonstrated capability and thorough understanding of quality management; Three years minimum direct personnel management and related leadership experience; ASQ Certified Quality Engineer certification preferred; Must have experience in GMP electro-mechanical product design and manufacturing; Requires highly developed leadership skills and experience, including the ability tomap task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Must be skilled at delegation, follow-up, and team building.
Head of Molecular Analysis – Mountain View, CA
An early stage, recently funded company with revolutionizing early cancer detection and prevention technology, comprising of simple, accurate, and proprietary blood test, has an immediate opening for Head of Molecular Analysis. This is a critical, highly visible position and requires minimum 8-10 years experience in both hands-on analysis and strategic experience to build the team. There will be equity sharing in addition to competitive salary. Will require frequent travel to Taiwan and ability to speak Mandarin is a huge plus.
The successful candidate will lead, design and implement the overall molecular analytical approach to be adopted by the company for early cancer detection through the use of “rare cell” technologies. Working with the R&D team in Taiwan, s/he will design and build the molecular assay platform and panels for identifying major types of cancer. In addition, this person will lead the effort to productize the molecular fingerprinting panels so that they can be offered for sale commercially worldwide. Being in a fast moving start up environment, the candidate is expected to be hands-on as well as capable of building and managing a team over time.
Responsibilities: Develop and maintain a map of suitability characteristics of molecular techniques to identify / confirm cancers through rare cells isolated by the company platform; Develop & implement a plan to build a molecular assay platform to identify major cancer types; Productize developed “rare cell fingerprinting panels” for specific cancer types per the company’s product road map; Advise and assist on optimizing existing & new assays for stability, specificity, sensitivity & reproducibility, following the principles of design control; Setup & manage a molecular lab in the US to supplement/complement the Taiwan lab; Evaluate the feasibility of ctDNA (circulating tumor DNA) & if applicable develop a ctDNA assay; Evaluate & make recommendations on the costs/ benefits of commercializing alternative techniques; Monitor & ensure implementation of goals to meet established quality assurance, quality control & quality improvement plans; Act in accordance with regulatory compliance requirements, including but not limited to company’s quality system requirements; Represent the company at major annual conferences through publications & speaker panels; Work cross functionally to patent innovations worldwide.
Skills & Experience: Ph.D. or equivalent degree in Cell or Molecular Biology, Biochemistry, Immunology or other biomedical science with 5 – 10 years of relevant industrial experience; Generation, isolation & sub cloning of nucleic acids from genomic, mRNA & recombinant sources through PCR, restriction digestion, ligation, transformation & transfection or other techniques; In-depth knowledge & expertise in developing automated molecular assays or methods, including real-time PCR, next generation sequencing, or others; Skills in optimizing assay design & condition, including Design of Experiments (DOE) optimization where appropriate; Familiarity with “rare cell” technologies for cancer detection and screening including CTCs, cell free DNA and other cancer markers, desirable but not required; Have an in-depth understanding of the research laboratory environment and be familiar with complex laboratory equipment / instrumentation, including working experience with perishable samples such as human blood; The candidate should demonstrate a track record of creativity and innovation in hypothesis building and experimental design to deliver definitive results; Record of significant contribution to publications in peer reviewed journals and presentations at scientific meetings; Proficiency in conducting studies under design control, and in technical writing for study protocols, data summaries and technical reports, suitable for submission to regulatory agencies; A team player with excellent oral and written communication skills; Capable of adjusting to a dynamic start-up working environment and changing priorities; Working knowledge of data analysis and interpretation, and statistical analysis; Willing to travel to Taiwan.
Director of R&D/ Mechanical Engineering – San Jose, CA
There is an immediate opening for Director of R&D Mechanical Engineering in an early stage company developing a novel approach for the oral delivery of large drug molecules. This position is responsible for effectively leading multi-project R&D efforts of the organization through technical expertise, interpersonal skills & a clear vision for execution.
Responsibilities: Manage resources to accomplish multi-project product research & development; Provide Mechanical Engineering support to meet R&D objectives; Remain current on developments in field(s) of expertise and industry trends; Actively pursue development of corporate IP; Identify future product opportunities; Develop plans & analyses for execution and review with leadership team; Maintain & update appropriate controlled documentation; Mentor junior staff members.
Skills & Experience: Demonstrated leadership of technical teams in medical device field; aptitude for & mastery of Mechanical Engineering principles; problem solving skills in a multidisciplinary environment; Proficient with statistical analysis for engineering and manufacturing; ability to work closely with team members across engineering & non-engineering disciplines such as biochemistry, physiology, pharmacology & chemistry; Knowledge of plastic manufacturing processes including injection molding, thermoforming, casting, machining, extrusion etc.; Knowledge of metals & alloys used in medical devices and processing techniques such as brazing, laser welding & cutting, electropolishing, electroplating, machining etc.; Deep experience in polymer processing, catheter design & fabrication, including knowledge of polymer joining, fusing, die cutting, adhesives etc.; Knowledge of biomaterials & coatings suitable for implantation; Knowledge of packaging & sterilization techniques; ability to interface effectively with professionals in the medical and biological sciences; knowledge of sound design principles, regulatory requirements, and product and process validation procedures; proficiency with computer aided design software & hardware. Formal training on systems & software is desired.
Also required: Bachelor’s degree or higher in Mechanical Engineering; 10+ years experience in engineering and product development with demonstrated capability & thorough understanding of the medical device product development process; Three years minimum direct personnel management & related project leadership experience; ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines & develop, monitor and live within budgets as well as ability to forecast major milestones. Must be skilled at delegation, follow-up, and team building.
Research Engineer – San Francisco, CA
A company working on highly advanced and innovative consumer health sensing technology, has an immediate opening for Research Engineer in San Francisco, CA. Responsibilities include, research, implement, and analyze cutting edge physiological sensors and signal applications, help design and trouble shoot experiments for top secret projects pertaining to future product offerings, and work closely with excellent research and device team to ingrate the work into amazing consumer products. Requirements include, Bachelors in Engineering plus 2 years experience or MS in Engineering, proficiency sensors, signal processing, and exploratory data analysis. DSP techniques including time series analysis, adaptive filters, and noise cancellation, demonstrated ability in a scientific computing language (R, Python, and/or Matlab), and passion for health, wellbeing, and fitness are great plusses. An advanced degree, Knowledge of NoSQL database systems, biomedical engineering background, prior experience in physiological sensors, real time biological data processing, Electrical Engineering, etc. are huge pluses. This is a contract to hire opportunity, for local residents only (no visa processing). The opportunity will start as full time contract opportunity and will turn into permanent opportunity in a period of 3-6 months. Compensation will be between $30 and $45 an hour and will include stock options, as added incentive.
General Manager – Software Engineering, Life Sciences – CA
There is an immediate opening for General Manager of Software Engineering in Life Sciences Division, with a large company near Dublin, CA, with a broad portfolio of transformational medical technologies in medical imaging & information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, & biopharmaceutical manufacturing technologies. The focus is in helping physicians detect disease earlier and to tailor personalized treatments for patients, & improving productivity in healthcare and enhance patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, & other conditions.
The GM for Life Science Software Engineering is a key member in the Chief Technology Officer’s Executive Leadership team. The position requires excellent technical and operational knowledge coupled with superior people leadership skills, program management experience and business planning processes. The GM, Software Engineering will: Provide advanced technical expertise and thought leadership in the area of strategic software development and governance; Lead and drive next generation product software strategies and services. With strong leadership and close collaboration with functional business leaders ensure Life Sciences software architecture is set to meet the needs of the future; Align strongly with and leverage the San Ramon software center of excellence; Drive business innovation and transformation with strong platform leadership. Move away from point solutions towards effective processes and tools, creating a change-enabled architecture platform, enabling flexibility and agility in the business; Maximize the value of each SW/IT investment Lif Science division. Focus on not just solving and solution for today’s projects, but solving for tomorrows needs by building the longer term plans (architecture blueprints and roadmaps) and driving projects to align to the longer strategic plans. Adapt HC SW solutions and COE architecture wherever efficient and applicable in a lean fashion; Drive efficiency to Maximizing the reuse and Simplification. The future Architecture must ensure that we drive towards a more standardized and reuse based SW development; Drive implementation of processes and tools for efficient and effective global software development lifecycle; Drive Life sciences wide software governance to ensure goals and targets are met and are measurable. Lead the Life Sciences review processes for software architecture; Integrate internal and external product design into a cohesive world class user experience; lead and direct activities within the Life Sciences business software area including reference application architecture; content models design patterns; service-based architecture strategy, development and support and other areas; Be responsible for program budgets and/or cost centers, resource allocation and planning to ensure delivery of business benefits.
Desired Skills & Experience
Minimum Qualifications: Bachelor’s degree CS/MIS or similarly positioned technical discipline; Minimum twelve years IT experience; At least eight years of leadership experience leading large design efforts and coordinating project for reputed multinational IT organizations; At least five years as a manager of geographically distributed development teams with 10 or more members.
Preferred Qualifications: Masters in Computer Science or similar discipline; Experience with a broad array of Infrastructure technologies (compute, network, telecom, database, etc.); Demonstrated program management skills including project initiation, scoping, resourcing, scheduling, budgeting, risk management and communication ; Project management experience in global environments; Excellent interpersonal, presentation and facilitation skills; Ability to learn complex systems and business processes and define requirements for solutions; Mastery of user interaction design skills; Familiarity with field and lab-based usability research methodologies; Ability to communicate design rationale and build consensus; Ability to prioritize and manage work to critical project timelines in a fast-paced environment; Previous experience in medical devices; Expert understanding of regulatory requirements, IT SOPs and Validation SOPs; Experience working in Agile Environment.
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.
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.