Abbott jobs in Sunnyvale, CA - 1232 jobs

A global healthcare leader in Santa Clara is seeking a Senior Manager to lead the US TAVI field and customer training programs. This position involves collaborating on global training curriculum, ensuring optimal outcomes, and developing a US-based training team. The ideal candidate will have a Bachelor's degree, at least 5 years of experience, and strong program management skills. Competitive salary and significant contributions to training innovations are part of the offerings. #J-18808-Ljbffr

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences is seeking a highly motivated, adaptable, and experienced Program and Project Management leader to start up a new state-of-the-art Single-Use DS Biologics Manufacturing facility in Foster City and integrate this facility with existing Foster City cGMP Manufacturing activities. As the Foster City Manufacturing Operational Readiness Program Lead, you will design, build and manage the multi-year cross-functional program of activities and workstreams involved in transitioning Gilead's new Foster City biologics manufacturing facility from capital project into routine cGMP production. You will help ensure that the systems, people, and processes are in place to support clinical manufacturing and future commercial launches. This is a unique opportunity to shape the future of Foster City Manufacturing for Gilead and make a lasting impact on global health. Job Responsibilities Coordinate the creation of an Operational Readiness Program and reinforce a sense of purpose and ownership among all team members. Structure distribution of responsibilities across multiple workstreams within the program, drive prioritization and sequencing of workstreams, and partner with the Capital Project team to align operational and project timelines, deliverables, and resources. Evaluate industry best practices and select an appropriate program and project delivery model that supports the dynamic nature of a new facility startup and integrates with Gilead's existing governance and delivery frameworks. Select and manage the tools, standards, business processes, documentation, metrics, and communications associated with the Operational Readiness Program. Partner with IT and key stakeholders to pilot and implement innovative digital solutions for the Operational Readiness Program and Foster City Manufacturing. Organize, prioritize, sequence, and track workstreams, activities, and resources necessary for Foster City Manufacturing to support startup and Engineering project deliverables. Work with the Foster City Manufacturing Leadership Team, the Global Manufacturing organization, and senior leaders across PDM to develop a comprehensive Foster City Manufacturing site strategy document and own the portfolio of projects to achieve the site's long-term ambitions. Actively participate in defining and communicating the Foster City Manufacturing mission and vision in alignment with Gilead's corporate values. Act as a change agent to foster an inclusive and high performing organization with a culture of curiosity, continuous improvement, and innovation. Operate with an Enterprise-First mindset and a willingness to adapt and flex across functional boundaries as needed to achieve mission critical tasks. Minimum Required Education, Years of Experience and Qualifications Bachelor's degree in engineering, life sciences, or related field, and 10+ years of experience in biotech/pharma manufacturing or process development with a minimum of 2 years direct or matrixed people leadership experience. OR Masters' Degree and Eight Years' Experience in biotech/pharma manufacturing or process development with direct or matrixed people leadership experience 5+ years of project and portfolio management experience utilizing both traditional and agile project delivery methodologies. Strong understanding of cGMP compliance. Strong business and financial acumen. Proven experience successfully managing cross-functional teams and complex project timelines with significant components of uncertainty. Demonstrated ability to thrive in a dynamic environment and collaborate across diverse technical areas. Experience with Biologics Drug Substance manufacturing equipment and processes, Single-Use Technologies, and cGMP facility qualification and startup preferred. Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. #J-18808-Ljbffr

A leading biopharmaceutical company in Foster City is seeking an Associate Director/Principal Scientist to lead cell culture development for biologics programs. The ideal candidate will have significant experience in process development and team management, with a Ph.D. or relevant degree. This role involves optimizing processes, mentoring team members, and ensuring compliance with regulatory requirements. #J-18808-Ljbffr

United States - California - Foster City Process/Product Development & Operations Regular The Associate Director/ Principal Scientist , Cell Culture Process Development (Pivotal & Commercial), will be responsible for leading aspects of cell culture development including commercial process development and process characterization for multiple biologics programs during pivotal phases (phases II/III and post-launch). In addition, this role is also expected to lead projects for cell culture process technology development, platform process evolution, and to support cell culture-related regulatory documentation. Key Responsibilities Optimize and characterize cell culture processes to supply pivotal trials and enable commercialization for monoclonal antibodies, multi‑specifics, and novel modalities. Lead and/or support entire lifecycle of pivotal activities including process risk assessment, process characterization, preparation of all supporting documentation/reports toward BLA submission, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA. Lead and/or support technology transfer and investigation activities in partnership with the global manufacturing sciences and technologies (MSAT) group. Design experiments and perform hands‑on cell culture operations in shake flasks, ambr15, ambr250, bench‑scale bioreactors, and novel cell culture platforms. May provide support to pilot plant operation for up to 500 L single‑use bioreactor. Perform statistical analyses and appropriate modeling to assess process parameter criticality, identify acceptable ranges, and contribute to integrated control strategy. Author and review GMP and non‑GMP technical documents (reports, regulatory submissions/responses, batch records, SOPs etc.), present in group/cross‑functional meetings. Participate and work cross‑functionally within and outside of biologics technical development to achieve common goals. Explore, develop, and implement novel cell culture technologies to meet business needs. Manage direct and indirect reports and mentor junior group members while working in a flexible and agile environment. Some travel may be required to support technology transfers and provide oversight at external manufacturing facilities. Adhere to department budget and all training, compliance and safety requirements. Remain current on trends and new technology advancements across the Biopharmaceutical industry. Hire, mentor and develop team members within the organization to help build and grow a world‑class biologics cell‑culture process development organization. Qualifications Ph.D. with 5+ years OR M.S. with 8+ years OR B.S. with 10+ in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering). Experience leading pivotal stage cell culture process development/characterization and implementation in GMP facilities. Experience in building high‑performing teams through strategic coaching and feedback. Hands‑on laboratory operations experience including shake flask, high‑throughput bioreactor, bench scale bioreactor, and pilot scale cultures. Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving. Demonstrated ability to collaborate and influence cross‑functionally. Experience in cell culture media development, and/or employing modeling techniques for upstream process development and optimization is preferred. Experience in statistics, design‑of‑experiments, and data analysis (e.g. JMP, Spotfire). Working knowledge of lab automation, data management, data science, knowledge management and data protection. Experience with viral vaccines is a plus. Passion for inclusion: knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way he/she/they work. #J-18808-Ljbffr

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Pleasanton, CA location in the Heart Failure Division. Abbott is currently seeking an experienced commercial attorney to provide legal advice to Abbott's Heart Failure Division. The attorney will be expected to identify and resolve complex legal issues to support the operations of a global leader in the research, development, manufacturing, sales and marketing of medical device products. The ideal candidate will have experience working with healthcare providers and a solid understanding of payor agreement contracting principles as well as billing, reimbursement, compliance, and auditing guidelines and requirements. We encourage applications from individuals familiar with regulations governing Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) or Independent Diagnostic Testing Facilities (IDTFs). What You'll Work On Conducting reviews and revisions of payor agreements on request and offering legal advice on business payor relations and contracting strategies. Providing legal guidance on DMEPOS and IDTF operations and related standards, including billing, reimbursement, auditing, and compliance program activities. Offering advice on payor and reimbursement disputes to mitigate legal risks. Drafting, negotiating and reviewing a wide range of agreements, including complex matters relating to procurement, sales, licensing, marketing, co-promotion and research collaborations. Reviewing marketing programs and promotional materials to ensure compliance with FTC truth-in-advertising principles, Abbott policies and applicable law. Advising and ensuring that internal clients receive sound, practical and timely legal advice on a wide variety of legal matters related to operation of a commercial business that markets to health care professionals. Resolving legal issues using negotiation skills and legal expertise, including pre-litigation dispute resolution and settlements. Assisting in the creation of new template agreements, playbooks and training to support efficient contracting processes for various business functions. Developing knowledge of Abbott's businesses, products and client areas supported. Maintaining familiarity with laws that affect client areas to issue spot and provide basic counseling, including those relevant to sales and marketing of products to health care professionals and reimbursement by government programs, for example, fraud and abuse (Anti-Kickback Statute, False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption (Foreign Corrupt Practices Act); Representing Abbott externally to suppliers and customers; and Helping select and/or directing the work of outside counsel, defining project objectives, managing project, and monitoring outside counsel budget. This position will interact with the Legal, Compliance, Finance, Education, Supply Chain, Research & Development, Regulatory, Quality, Clinical, Marketing, Commercial/Sales, and Information Technology Departments. Infrequent and minimal travel may be required (10-15%). Critical Success Factors Good Judgment: Demonstrate expertise and sound judgment, understand how assigned responsibilities support Abbott's business objectives, and be able to provide practical, risk-balanced advice based upon a thorough understanding of the scope of an issue, taking full advantage of internal networks and external intelligence. Collaboration: Firm understanding of available legal, functional, and business resources and ability to integrate information from a number of sources to achieve business results, including breaking down boundaries to create alignment as necessary, in a complex, global, matrixed environment. Anticipation: Holistic, big picture thinker, who anticipates changes in law, enforcement, and/or business objectives and adapts approach as necessary to manage risks effectively and mitigate issues before they arise. Influencing Skills: Build strong relationships with business partners to tactfully influence and gain their support to drive desired outcomes. Represent Abbott externally to customers, suppliers, competitors or government agencies; and resolve legal issues using negotiation skills and legal expertise. Required Qualifications Juris Doctor degree from an accredited law school, demonstrate a strong academic background, and be admitted to a US state bar in good standing. 3+ years of experience as a commercial attorney at a top law firm and/or in-house Preferred Qualifications Regulated industry or other relevant industry experience strongly preferred. Experience with working with healthcare providers and a solid understanding of payor agreement contracting principles as well as billing, reimbursement, compliance, and auditing guidelines and requirements. Familiarity with regulations governing Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) or Independent Diagnostic Testing Facilities (IDTFs). Ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment. Ability to independently handle complex matters with minimal supervision and understand which issues to elevate to senior management and appropriate timing for doing so. In addition to top-notch legal skills and a strong ethical center, excellent interpersonal, strategic thinking, communication and organizational skills Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $146,700.00 - $293,300.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr

United States - California - Foster City Manufacturing Operations & Supply Chain Regular Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients. Exec Director, Global Supply Chain Strategic Sourcing and Supplier Management FOSTER CITY, CA Key Responsibilities: Reporting to the SVP of Global Supply Chain, and part of the larger Pharmaceutical Development and Manufacturing organization (PDM), the ED Strategic Sourcing and Supplier management will lead a team of Supply chain professionals sourcing and leading our outsourced CMO network. This role is accountable for the strategic business relationships with external suppliers of both Development and Commercial services and/or materials. This includes ownership of the strategy, selection, and performance management of all suppliers providing API, SDD, OSD, BDS, sterile DP, and secondary packaging services as well as all suppliers of direct materials including medical devices, primary packaging, excipients, and manufacturing consumables. This role collaborates closely with all PDM functional groups including RA, Tech Dev, Mfg. Ops, QA, Product & Portfolio Strategy, and Global Supply Chain and is accountable for continuous improvement and ongoing collaboration with our suppliers through product lifecycle. Responsibilities: Development and Commercial Programs: Own the strategic business relationship with suppliers of manufacturing services and direct materials including but not exhaustive: Accountable for sourcing of strategic partners, contract negotiation and ongoing business relationship with the suppliers. (MSAs, SOWs, Supply Agreements, Pricing, etc.) Lead strategic business discussions, long range supply and/capacity planning, and business development, through the product lifecycle and ensure financial discipline, win win and savings opportunities. Participate and contribute into CD & OP and S & OP. Management of supplier performance (monthly/annually) Key KPI: i.e., OTD, Batch Release First Time %). Deviation on time Closure (%), Batch Rejection Rate (%), Deviations per batch The escalation points for Mfg. Ops team members for recurrent or chronic performance issues from suppliers Lead quarterly / annual business review meetings (BRMs) with strategic/high suppliers Lead the assessment and mitigation of supplier risks through regular supplier risk management processes BCP plans with suppliers articulated and desk top exercises completed to ensure robustness Responsible for preparation and tracking of RFPs/RFQs for new business with external suppliers and in consultation with functional stakeholders (Mfg. Ops, Tech. Dev. QA, etc.) In collaboration with Product and Portfolio Strategy team members, identify and manage strategic suppliers of manufacturing services in alignment with network supply chain strategies Own the development and execution of supplier strategies for direct material suppliers Identify and manage strategic suppliers of direct materials in alignment with approved CMT strategies Establish quality and technical execution expectations with vendors Segment our supplier and have a strategy for strategic and tiered suppliers. Articulate digital roadmap and integration with key suppliers, plan and execute against it Sustainability and resilience strategy articulated with key suppliers Development/Clinical Programs: Providing intel, options, and solutions; staying informed and knowledgeable of relevant Development CDMO and material supplier capabilities, offerings, capacities, etc. as they relate to potential or known Gilead pipeline needs Leading site assessment teams (SATs) and/or category management teams (CMTs) for the assessment and selection of new service or material suppliers to meet Development program needs Ensuring the full scope of supplier selections made during Development align with Commercial manufacturing and/or network strategies, as necessary. Establish quality and technical execution expectations with vendors Prepare and/or review agreements covering confidentiality, supply terms & conditions, and quality Commercial Programs: Providing intel, options, or solutions; staying informed and knowledgeable of relevant Commercial CMO and material supplier capabilities, offerings, capacities, etc. as they relate to Gilead Commercial supply needs Leading site assessment teams (SATs) and/or category management teams (CMTs) for the assessment and selection of service or material suppliers to meet commercial Program needs Qualifications: Primary degree in Business, Science or Engineering discipline. Master's degree and/or professional qualifications in supply chain management desired. 15+ years of biopharmaceutical industry experience with at least 5 years of experience focused on management and leadership roles with contract manufacturers in a supply chain capacity. Experience developing, implementing, and executing strategic plans and objectives for organizations and departments. Solid understanding of current industry trends. Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence, coaching, goal setting and performance management. Strong business acumen. Capability to navigate and lead in a highly matrixed environment. Demonstrated ability to understand complex and complicated situations and to strip out complications. Effective communication skills, both written and verbal. Can make convincing arguments, inspire action, and bridge diverse cultures. Capable to communicate the world of PDM to people outside of PDM, and to communicate about the world outside of PDM to those inside. Negotiation and conflict resolution skills. A proven capability to contribute to your team's success through servant leadership. A proven capability to contribute to the success of PDM and Gilead as a senior leader. Gilead Core Values Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) #J-18808-Ljbffr

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings plan with high employer contribution Tuition reimbursement, Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology. Our Diabetes division currently has an opportunity for a Senior SDET working on mobile automation.#software What You'll Do Complete software testing and activities in conjunction for user stories within the Agile SDLC process. Review deliverables/activities as identified in the test plans for accuracy, consistency, completeness and compliance. Ensure adequate test coverage for every release. Strategically incorporate automated testing into the SDLC. Develop and Optimize Automation Scripts and Frameworks: Design, code, and manage automation scripts using Python. Work on automation framework (like appium, selenium, Robot etc..). Focus on enhancing the efficiency and scalability of these scripts across various applications, from data handling to system configurations. Automation of Testing Processes: Develop comprehensive automated testing frameworks to support both unit and integration testing. Ensure these frameworks adhere to the rigorous quality standards of the medical industry. Perform exploratory testing, system level end to end testing, develop test datasets and execute automation scripts (to ensure application software releases are of high quality). Automation Solutions Customization: Tailor automation solutions to meet the specific needs of the medical industry, focusing on regulatory compliance and operational efficiency. Maintenance and Enhancement of Automated Systems: Regularly review and optimize existing automation systems. Identify new opportunities for automation within the company's processes to reduce manual intervention and increase reliability. Collaboration and Technical Leadership: Provide guidance and support to other team members on best practices in automation. Lead automation projects and collaborate with stakeholders to ensure alignment with business and technical requirements. Technical Documentation and System Documentation: Produce high-quality documentation for all automated systems and updates. Ensure documentation meets compliance standards required in the medical industry. Required Qualifications Bachelor's degree, or equivalent experience, in a scientific, technical, or engineering discipline. 5+ years' experience in Software Testing and/or Software Quality Assurance. 5+ years' experience working as Software Development Engineer in Test (SDET). 4-6 years' experience in hands on coding in Python. Must be technically strong and have experience testing mobile applications. Must have excellent oral and written communication skills. Preferred Qualifications Computer Science degree strongly preferred. Experience of working in a regulated industry. Medical Device experience strongly preferred. Experience in an agile development environment. Cyber security, medical mobile applications or cloud computing experience. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $85,300.00 - $170,700.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr

Expertise in equipment and manufacturing process, capability to support multiple process areas 3+ years of leadership and project management skills; Lead executions of Manufacturing related engineering projects. Works on several different projects and prioritizes these projects with guidance Proficiency in all of the following fields equipment, process/materials, maintenance, project delivery Support investigations, owns CAPAs, and responsible or product impact assessment, and risk assessments related to manufacturing processes. Lead solving activities to resolve critical issues, planned and unplanned activities, and anticipate future engineering developments within maintenance/process area Designs studies, accomplishes experiments/protocols and perform data analysis. Develop and optimize processes within own area of process engineering . • Track, trend, and analyze in-process data using statistical process control (SPC) methods. Monitor and improve process performance. Share technical knowledge and expertise with personnel in AstraZeneca to aid technical developments within the organization. Recommend and implement transformation/ continuous improvement initiatives within site with focus on cost saving and improvement of quality and efficiency. Employ Good Engineering Practices to streamline project executions ;collaborates with multi-functional teams to solve problems Provide mentorship and coaching to junior engineers, interns, and manufacturing technicians Guide execution of processes (e.g., validation, qualification, operation, evaluation and troubleshooting of process deviations) within process engineering area. Participate in communications with relevant internal teams (e.g., regulatory) for management of change control. Guide and track compliance of own work and work of others with SHE and other applicable standards and regulations. Provide engineering solutions to manufacturing challenges and meet all safety, quality, supply and requirements. Develop contacts across a range of departments and external groups acting as engineering representative. Equipment Management Prepare equipment for qualification activities, including but not limited to: TOP preparation and review, initial testing and qualification readiness Handles production equipment. Maintain equipment maintenance strategies, and equipment lifecycle management Lead/ guide planning, managing, and monitoring of major manufacturing and maintenance plan projects from concepts to implementation Lead equipment specification, design, build, commissioning and qualification to meet technical/safety/ and business Essential Requirements: Bachelor's degree in Chemical or Mechanical Engineering Minimum of 3 years relevant experience. Breadth of experience to establish credibility with key stakeholders. Industry experience in a GMP environment Preferred Experience: 5 years of relevant experience Large Capital project management and execution experience Lean certification Experience with automatic process controls Root cause investigation training/ 6-simga TPM experience Experience with spray-drying technology Experience with equipment maintenance Experience with regulatory inspections and handling deviations Experience working within cross-functional teams. Has experience in change control, budget and project management, including a track record of driving continuous improvement initiatives. Project management track record of delivering projects Data Analysis tools (SQL, JMP, Minitab) , visual management tools (Powerbi, PowerApps) The annual base pay for this position ranges from $97,372 - $146,058. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 22-Dec-2025 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: * Career development with an international company where you can grow the career you dream of. * Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. * An excellent retirement savings plan with a high employer contribution * Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. * A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. * A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. Abbott Point of Care (APOC) is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making. The i-STAT System has the industry's most comprehensive menu of tests in a single, with-patient platform, including tests for blood gases, electrolytes, chemistries, coagulation, hematology, glucose, and cardiac markers. By delivering lab-quality results in minutes, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance. The Opportunity We are hiring a Point of Care Solutions Specialist in our Abbott Point of Care (APOC) Division selling to hospitals in the San Francisco Bay Area. The Point of Care Solution Specialist works independently within an assigned territory leading commercial execution to increase market share and drive sustainable growth. Working in a collaborative environment, the Sales Specialist will partner with internal support team members to identify opportunities and create strategies that move sales cycles forward. The position reports to the District Manager and requires up to 50% travel to provide customer-focused service and effectively support business goals. What you will work on * Achieve sales targets through efficient and effective sales cycle and territory management. * Maintain sales base while closing new business in both new and existing accounts. * Efficiently navigate complex sales environments with multiple stakeholders and dynamic decision-making criteria, while also building relationships. * Develop and execute sales strategies, while anticipating potential risks and proactively developing and implementing mitigation plans. * Utilize available resources effectively. * Ensure that all administrative tasks (i.e., training modules, expense reports, sales forecasts, etc.) are completed promptly and accurately. * Travel within assigned territory is up to 50% and will provide customer-focused service and effectively support business goals. some regional, overnight travel is required. * Understands and complies with all applicable EHS policies, procedures and guidelines. * Responsible for implementing and maintaining the effectiveness of the Quality System. Required Qualifications * Bachelor's degree * 4+ years of relevant sales experience or 0-3 years of experience with a Clinical background (BSN, MLT, CLS, RT, Cardiac Tech, etc.) * Must reside in territory and be able to travel up to 50% in territory and other business locations (as necessary). Preferred Qualifications * Documented history of being a consistent sales overachiever (i.e., President's Club winner). * Consistently ranks among the top 20% in peer sales group. * Diagnostics, point of care (POC), lab, or capital equipment sales experience. * Has established contacts at IDN's and Hospital Systems within assigned territory. * Possesses strong MS Office (Excel, PowerPoint, and Word) skills. * Highly proficient at using the Salesforce.com, or similar, CRM platform. * Attended multiple sales training courses (e.g., Challenger, Miller Heiman, etc.), and is an active user of one or multiple effective sales methodologies. Learn more about our benefits that add real value to your life to help you live fully: ********************** Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at *********************** and on Twitter @Abbott News and @AbbottGlobal. The base pay for this position is $68,000.00 - $136,000.00. In specific locations, the pay range may vary from the range posted.

Abbott Laboratories is seeking an experienced commercial attorney for their Heart Failure Division in Pleasanton, CA. The role involves providing legal advice, handling complex agreements in the healthcare sector, and ensuring compliance with various regulations. Candidates should have a Juris Doctor and significant experience in related fields. This opportunity offers competitive compensation and benefits as part of a global leader in medical devices. #J-18808-Ljbffr

* Performs as a leader within Global External Manufacturing to execute the network strategy. Responsible for tactical manufacturing strategy, execution of the business with external manufacturing organizations, and management of supplier performance* Partner in development of department strategy aligned with corporate and PDM goals into functional/departmental objectives to realize the targeted outcomes* Proactively and effectively leads collaboration with functions within and external to PDM to achieve corporate, cross functional, and departmental goals* In collaboration with Technical Development Organization, defines the technical requirements and actively partners with Global Supply Chain in selection of CMOs, and influences overall performance of the network CMOs to achieve Gilead's strategic and tactical business outcomes, including Key Performance Indicators* Proactively partners with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s)* Leads the regular, tactical management of CMOs to ensure Gilead's products are manufactured in accordance with the registered process and approved Master Production Record* Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control* Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability* May represent Gilead as a liaison between the company and various governmental agencies as required* Demonstrated track record in oral solid dosage drug product manufacturing and supply chain execution in the pharmaceutical industry* Expertise in supply risk management, possessing in-depth knowledge of industry and system best practices* Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance* Solid understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities and limitations for worldwide drug product manufacturing is a plus* Ability to travel internationally, including overnight, up to 10% of the time is required* Exceptional verbal and written communication skills, including ability to interact effectively with senior management* Demonstrated ability to understand and resolve complex situations* Proven leadership capability to contribute to the success of PDM and Gilead* 12+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering, an advanced degree in science, engineering, or business is desirable* An MBA degree can be substituted for 10 years of relevant experience, a Ph.D. degree can be substituted for 8 years of relevant experience #J-18808-Ljbffr

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we're committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. As a Senior Demand Planner, you will execute analytical activities supporting Sales and Operations - S&OP - forecasting and demand planning; participate in the development of demand-based sales forecasts for the Diabetes Care product portfolio, including Freestyle Libre and Blood Glucose Monitoring devices. You will be a visible member of the team, and effectively work cross-functionally to achieve organizational and profitability goals. This is an onsite opportunity in Alameda, CA. What You'll Do Responsible for executing tactical components of monthly Demand Planning and IBP (Integrated Business Planning) processes including but not limited to: consensus forecasts, cross-functional assumption alignment, and management review presentations; backorder tracking, reporting and resolution; managing the supply change request (SCR) process; Work cross-functionally to achieve organizational goals; coordinate with commercial management to develop product life cycle; drive adherence to accountability; support project teams to ensure project success. Review historical sales trends, research demand drivers, prepare forecast accuracy data, and evaluate forecast results. Evaluate forecast accuracy and determine action plans to improve accuracy. Generate predictable sales forecasts for maximum benefit of resource allocation, capital utilization and investment decisions, including ability to dependably manage inventory tightly, reduce distressed inventory and assess staffing requirements; responsible for managing lot sequestering for key customers and the allocation process. Develop and recommend contingency plans in response to unexpected changes in demand/supply; provide timely and thorough assessment of problems and formulate solutions; propose solutions which present minimal disruption to the business; develop processes to mitigate re-occurrence. Provide regular benchmarking and adjust processes when beneficial. Participate in the preparation of executive level summaries and key assumptions, findings and observations along with actionable information; interpret ambiguous data; draw conclusions and provide recommendations. Resolving conflicts to deliver consensus forecasts across the functional groups. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Understand and comply with applicable EHS policies, procedures, rules and guidelines. Responsible for implementing and maintaining the effectiveness of the Quality System. Experience You'll Bring Required Bachelor's degree or equivalent experience required. Typically requires 4 years of relevant work experience to develop the competence required to meet the skills and responsibilities of the position. Advanced use of Microsoft Office applications, with a specific focus on Excel; working knowledge of SAP/Symphony, Dodeca, and Data Analytics tools such as Power BI preferred. Must possess strong analytical and communication (Oral and written) skills and the ability to work well under pressure and meet tight deadlines. Proven experience influencing partner executives and are capable of influencing internal decision-makers to make decisions aligned with strategies and objectives benefiting the entire organization. Ability to clearly, concisely and accurately convey communications. Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior. Ability to work independently and in groups. Demonstrated initiative and problem-solving skills; critical-thinking skills. Ability and aptitude to use various types of databases and other computer software. Ability to prioritize. Strong organizational and project management skills. Ability and aptitude to provide solutions and contingency plans through the comprehensive review of alternatives. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews. Divisional Information Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. CRM As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Diabetes We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology. Vascular Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. Neuromodulation Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Structural Heart Structural Heart Business Mission: why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. EP In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. HF In Abbott's Heart Failure (HF) business, we're developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. Diagnostics We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people. Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level. Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges. Nutrition Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac , PediaSure , Pedialyte , Ensure , and Glucerna - to help them get the nutrients they need to live their healthiest lives. The base pay for this position is $86,700.00 - $173,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Market Development and ResearchDIVISION:ADC Diabetes CareLOCATION:United States > Alameda : 1360-1380 South Loop RoadADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 5 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************

A global healthcare leader in San Francisco is seeking an Associate Director for their External Partnering team. This role focuses on driving molecule discovery and technology licensing, enhancing portfolio growth through new business opportunities. Candidates should possess deep knowledge in drug discovery, a minimum of 7 years experience in client services or sales within pharmaceutical environments, and strong relationship-building skills. Competitive salary range of $132,000 - $193,600 offered, alongside comprehensive benefits. #J-18808-Ljbffr

A global biopharmaceutical company seeks a Medical Science Liaison in San Francisco to support Cardiorenal marketed products. The role involves engaging with healthcare professionals, providing scientific support, and identifying patient management barriers. Candidates should have an advanced clinical degree and up to 2 years of experience in a clinical or commercial setting. Strong communication and leadership skills are essential. The position offers competitive pay and benefits. #J-18808-Ljbffr

A leading biopharmaceutical company in California seeks a Senior Manager, FP&A - Oncology Program Finance to support clinical spend and financial processes. The ideal candidate must have over 8 years of finance experience, strong analytical capabilities, and proficiency in Excel. This role involves partnership with Clinical Operations and leadership in financial analysis and reporting. A Master's degree or CPA is preferred, along with experience in the biotech sector. #J-18808-Ljbffr

The Phlebotomist III/Research Study Staff member is responsible for collecting blood specimens from subject donors within the facility for research analysis or testing purposes. The individual must be capable of working independently, demonstrating strong initiative, sound judgment, and the ability to manage tasks with minimal supervision. Responsibilities Assisting with participant recruitment, screening, and the informed consent process. Scheduling and coordinating study visits and specimen collection timelines. Accurately documenting study-related data in electronic or paper case report forms. Ensuring compliance with study protocols, IRB guidelines, and regulatory requirements. Communicating effectively with study participants, investigators, Occupational Health Nurses (OHN), and clinical teams. Performing blood sample testing as required. Qualifications: Associate or Bachelor's degree in a health or science-related field preferred. Completion of an accredited phlebotomy training program. 2 to 5 years of experience in phlebotomy and/or clinical research preferred. Skills & Competencies: Proficient in venipuncture/capillary blood collection and specimen handling techniques. Strong organizational and time management skills. Familiarity with clinical research protocols, Good Clinical Practice (GCP) and Good Documentation Practice (GDP). Excellent communication and interpersonal skills. Ability to work independently and collaboratively in a fast-paced research environment. Certification(s): Certified Phlebotomy Technician (CPT) or equivalent (required). Consultants Eligible Benefits Upon Waiting Period: Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account (for High-Deductible Health Plans) Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) Supplemental Life Insurance Short Term Disability (coverage varies by state) Long Term Disability Critical Illness, Hospital coverage, Accident Insurance MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance 401(k) Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.

United States - California - Foster City Manufacturing Operations & Supply Chain Regular KEY RESPONSIBILITIES Reporting to th e Senior Director , Pharmaceutical Development and Manufacturing (PDM) Operations Management , the Director , PDM Infrastructure will lead the team responsible for the key non-GMP systems that have an outsized impact on how we store, find and access non-GMP information in PDM. SharePoint ( G.Share ) and PDM apps like the PDM Team Rostering application ( G.Force ) will the initial areas of focus. PDM has generated a great deal of important non-GMP information ; being able to find and access such information easily and consistently across PDM will improve efficiency and speed . Success in this role depends on ongoing solicitation of feedback from PDM stakeholders and continuous improvement . FOCUS AREA S Lead the G.Share Sites and G.Share Business Apps teams Assess and prioritize current non-GMP infrastructure for knowledge sharing and identify areas for continuous improvement Serve as a member of the PDM Operations Management Leadership Team , connecting work that the PDM Infrastructure team does with the broader PDM Operations Management strategy Implement strategy and plan for enabling more efficient and consistent access to non-GMP information across PDM , making it easier and more efficient for PDM staff to get their work done Work effectively with partners in I T, with clearly defined roles & responsibilities. This role is not a technical systems role; it is the business side of information infrastructure and access BASIC QUALIFICATIONS: A degree in life sciences or a relevant business area with 12+ years of varied post-graduation experience in Pharmaceuticals, Biosciences or a related industry. Or MS with 10+ years of relevant experience. Or PhD with 8+ years of relevant experience. Strong business acumen, with demonstrated capability to translate information infrastructure to improved efficiency Strong experience with SharePoint and web-based information storage and access Demonstrated capability to navigate and lead in a highly networked environment and experienced with the required elevated level of influencing skills. Elevated communication skills, both written and oral. Strong presenter capable of engaging with, and facilitating conversations with, the senior leaders in the organization. Negotiation and conflict resolution skills. Experience developing, implementing, and executing strategic plans and objectives for departments, especially in a highly networked environment. Solid understanding of current industry trends. Experience leading a non-technical team that interfaces with technical teams Leadership qualities of the successful candidate include the following: collaboration, accountability, cross-functional engagement and influence, program management, strategic vision, goal setting and performance management. PREFERRED QUALIFICATIONS: Demonstrated capacity to understand complex problems and to implement solutions that are as simple as possible. Experience with knowledge management People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. Job Requisition ID R0046747 Full Time/Part Time Full-Time Job Level Director #J-18808-Ljbffr

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. + An excellent retirement savings plan with high employer contribution + Tuition reimbursement, the Freedom 2 Save (******************************************************************************************************* student debt program and FreeU (*************************************************************************************************************** education benefit - an affordable and convenient path to getting a bachelor's degree. + A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site at our Alameda, CA location in the Diabetes Care Division. We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology. This **Principal Regulatory Affairs Specialist** position is responsible for leading strategic planning as well as developing and deploying innovative solutions to ensure timely regulatory registration and release of products for distribution into specific geographies in the growing Asia Pacific (APAC) market. **What You'll Work On** + Executes and ensures timely product registration and release for distribution. + As the Regulatory Affairs functional lead, oversee and optimize processes and team efforts to obtain and maintain product registration/approval, completion of activities to support release authorization and ensure compliant release of product to specified geographies. + Drive strategic engagement with regulatory authorities during the development and review process, ensuring clear communication of complex technical concepts and resolutions to regulatory challenges to facilitate understanding and secure submission approval. + Coordinate with cross functional teams including but not limited to: global Regulatory Affairs (e.g., APAC, CALA, EMEAP and US), Commercial, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. Manage multiple programs independently, identifying risk areas and escalating issues as appropriate. + Product release process ownership. + Develops and refines processes and tools to support efficient and controlled product release. + Responsible for developing, maintaining, and ensuring compliance with applicable Corporate and Divisional policies and procedures. + Product registration, release authorization and release planning. + Provide Regulatory input to product lifecycle planning and project strategy based upon regulatory changes + Monitor for and guide team in responding to emerging regulatory issues + Evaluate product issues and develop informed, compliant solutions aligned with the regulatory requirements of the specific geography. + Acts as a liaison with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for major initiatives. + Hires, retains, and develops a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment. + Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. + Complies with applicable U.S. Food and Drug Administration (FDA) and international regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains professional and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors. **Required Qualifications** + Bachelor's Degree in Scientific discipline e.g. Chemistry, Life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices. + Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). + Strong verbal and written communications with ability to effectively communicate and present at multiple levels in the organization. **Preferred Qualifications** + Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields. + Masters in technical area or MBA; Doctorate in a technical area or law. + 5+ years' experience in regulatory affairs. + Scientific writing experience. + Solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU) 2017/745) and/or the In Vitro Diagnostic Medical Device Regulation (IVDR - Regulation (EU) 2017/746) + Experience working within an ISO 13485-certified Quality Management System + Proven international registration experience, ideally with a focus on Asia Pacific markets + Fluency in Chinese is highly desirable + Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). Apply Now (****************************** **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** ********************** (http://**********************/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at ************** , on Facebook at *********************** and on Twitter @AbbottNews.Connect with us at ************** , on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $100,000.00 - $200,000.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call ************ or email ******************

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our Diagnostics - Hematology team is hiring for a Hardware Engineer II out of our Santa Clara, CA office. They will design hardware to support features that are included as part of new product. Designs verification testing (DVT) protocols. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective and cost-efficient best practices to execute processes; continually evaluates their effectiveness and appropriateness. What You'll Work On Performs system design of diagnostic instrumentation. Selects components, processes, and foundries. Proposes design alternatives. Designs hardware to support features that are contained in the product definition. Develops hardware design specifications and circuit designs, and is responsible for technology selection. Assists the product definition team with feature selection. Provides recommendations to management regarding tools and product architecture. Evaluates and selects appropriate components and technologies Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Implement new design features as part of existing systems. Deliver research information which adds value to management's decision-making process. Qualifications Bachelor's degree in engineering or related field OR an equivalent combination of education and work experience Minimum 3 years of experience in hardware design, development, or testing experience, including a general familiarity with manufacturing equipment/processes that are compatible with highly reliable electronic medical or similar devices. Demonstrated personal computer skills, including spreadsheet, word processing, database management, and specialized applications. Advanced credential in a relevant discipline/concentration and/or professional certification desired. Six-Sigma knowledge and experience desired. Training and experience in manufacturing processes and methods and in the manufacturing of medical devices desired. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Strong organizational and follow-up skills, as well as attention to detail. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: *************************** Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at abbott.com, on LinkedIn at ****************************************** and on Facebook at *************************************** The base pay for this position is $79,500.00 - $138,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Product DevelopmentDIVISION:CRLB Core LabLOCATION:United States > Santa Clara : 4551 Great America ParkwayADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 10 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work requiring repeated bending, stooping, squatting or kneeling Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************