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Abbott jobs in San Francisco, CA - 1294 jobs

  • Regional CRM Sales Director - Cardiac Rhythm Leader

    Abbott Laboratories 4.7company rating

    Abbott Laboratories job in San Francisco, CA

    A global leader in health solutions is seeking a Regional Sales Director for Cardiac Rhythm Management in San Francisco, CA. The ideal candidate will manage CRM sales efforts, assist with contract negotiations, and develop a high-performing team. They should have substantial experience in the cardiovascular sector, demonstrate leadership skills, and possess a bachelor's degree in business or related fields. This role includes extensive travel and offers competitive compensation. #J-18808-Ljbffr
    $136k-184k yearly est. 2d ago
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  • Senior Commercial Counsel - Healthcare Payor Contracts

    Abbott Laboratories 4.7company rating

    Abbott Laboratories job in Pleasanton, CA

    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
    $132k-182k yearly est. 5d ago
  • Assoc Director, Data Scientist

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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. Gilead's AI Research Center(ARC) is looking for a Principal Data Scientist to spearhead the adoption of AI/ML and transform our clinical development processes. This is a pivotal role where you will provide key thought leadership and drive our strategic vision for advanced analytics, with the goal of optimizing clinical trials, enhancing data-driven decision-making, and providing support for Real-World Evidence (RWE), Clinical Pharmacology, and Biomarkers initiatives. You will be a thought leader in applying AI/ML to real-world clinical challenges, taking deep involvement in all stages of technical development-from coding and configuring compute environments to model evaluation, review, and architecture design. You'll work closely with a variety of cross-functional teams, including architects, data engineers, and product managers, to scope, develop, and operationalize our AI-driven applications, with a specific focus on leveraging AI/ML to advance insights within RWE, Clinical Pharmacology, and Biomarkers. Responsibilities: Innovate and Strategize: Spearhead the strategic vision for leveraging AI/ML within clinical development. You'll partner with cross-functional leaders to identify high-impact opportunities and design innovative solutions that transform how we conduct trials and make data-driven decisions. Lead with Expertise: Guide the full lifecycle of machine learning models from initial concept to real-world application. This includes architecting scalable solutions, hands-on algorithm development, and ensuring models are rigorously evaluated and operationalized for use in RWE, Clinical Pharmacology, and Biomarkers. Mentor and Empower: Act as a force multiplier for our data science team. You'll coach and mentor senior and junior data scientists, fostering a culture of technical excellence and continuous learning. Translate and Execute: Serve as a bridge between technical teams and business stakeholders. You'll translate complex business challenges into precise data science problems and, in a product manager-like role, drive the development of these solutions from proof-of-concept to production. Drive Breakthroughs: Research and develop cutting-edge algorithms to solve critical challenges. This could involve using NLP for patient insights, computer vision for biomarker analysis, or predictive models to optimize trial logistics. You'll be at the forefront of applying these techniques in a biotech context. Build the Foundation: Design and implement the technical and process building blocks needed to scale our AI/ML capabilities. This includes working with IT partners to curate and operationalize the datasets essential for fueling our analytical pipelines. Influence and Advise: Interface directly with internal stakeholders, acting as a trusted advisor to help them understand the potential of advanced analytics and apply data-driven approaches to optimize clinical trial operations. Stay Ahead: Continuously monitor the landscape of machine learning and biopharmaceutical innovation. You'll ensure our team is leveraging the latest state-of-the-art techniques to maintain a competitive edge. Technical Skills: Advanced Model Development & Operationalization: Deep expertise in developing, deploying, and managing complex machine learning and deep learning algorithms at scale. This includes a profound understanding of model evaluation, scoring methodologies, and mitigation of model bias to ensure robust, ethical, and reliable outcomes. Data & Computational Proficiency: Fluent in Python or R and SQL, with hands-on experience in building and optimizing data pipelines for analytical and model development purposes. Cloud-Native AI/ML: Demonstrated experience with Cloud DevOps on AWS as it pertains to the entire data science lifecycle, from data ingestion to model serving and monitoring. Translational Research: Proven ability to translate foundational AI/ML research into functional, production-ready packages and applications that directly support strategic initiatives in areas like RWE, Clinical Pharmacology, and Biomarkers. Basic Qualifications: Doctorate and 5+ years of relevant experience OR Master's and 8+ years of relevant experience OR Bachelor's and 10+ years of relevant experience Preferred Qualifications: Ability to translate stakeholder needs into clear technical requirements, including those related to RWE, Clinical Pharmacology, and Biomarkers. Skill in scoping project requirements and developing timelines. Knowledge of product management principles. Experience with code management using Git. Strong technical documentation skills. Join us at the AI Research Center to shape the future of clinical development with groundbreaking AI/ML solutions, and contribute to advancements in RWE, Clinical Pharmacology, and Biomarkers! The salary range for this position is: Bay Area: $210,375.00 - $272,250.00.Other US Locations: $191,250.00 - $247,500.00. 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's AI Research Center(ARC) is looking for a Principal Data Scientist to spearhead the adoption of AI/ML and transform our clinical development processes. This is a pivotal role where you will provide key thought leadership and drive our strategic vision for advanced analytics, with the goal of optimizing clinical trials, enhancing data-driven decision-making, and providing support for Real-World Evidence (RWE), Clinical Pharmacology, and Biomarkers initiatives. You will be a thought leader in applying AI/ML to real-world clinical challenges, taking deep involvement in all stages of technical development-from coding and configuring compute environments to model evaluation, review, and architecture design. You'll work closely with a variety of cross-functional teams, including architects, data engineers, and product managers, to scope, develop, and operationalize our AI-driven applications, with a specific focus on leveraging AI/ML to advance insights within RWE, Clinical Pharmacology, and Biomarkers. Responsibilities: Innovate and Strategize: Spearhead the strategic vision for leveraging AI/ML within clinical development. You'll partner with cross-functional leaders to identify high-impact opportunities and design innovative solutions that transform how we conduct trials and make data-driven decisions. Lead with Expertise: Guide the full lifecycle of machine learning models from initial concept to real-world application. This includes architecting scalable solutions, hands-on algorithm development, and ensuring models are rigorously evaluated and operationalized for use in RWE, Clinical Pharmacology, and Biomarkers. Mentor and Empower: Act as a force multiplier for our data science team. You'll coach and mentor senior and junior data scientists, fostering a culture of technical excellence and continuous learning. Translate and Execute: Serve as a bridge between technical teams and business stakeholders. You'll translate complex business challenges into precise data science problems and, in a product manager-like role, drive the development of these solutions from proof-of-concept to production. Drive Breakthroughs: Research and develop cutting-edge algorithms to solve critical challenges. This could involve using NLP for patient insights, computer vision for biomarker analysis, or predictive models to optimize trial logistics. You'll be at the forefront of applying these techniques in a biotech context. Build the Foundation: Design and implement the technical and process building blocks needed to scale our AI/ML capabilities. This includes working with IT partners to curate and operationalize the datasets essential for fueling our analytical pipelines. Influence and Advise: Interface directly with internal stakeholders, acting as a trusted advisor to help them understand the potential of advanced analytics and apply data-driven approaches to optimize clinical trial operations. Stay Ahead: Continuously monitor the landscape of machine learning and biopharmaceutical innovation. You'll ensure our team is leveraging the latest state-of-the-art techniques to maintain a competitive edge. Technical Skills: Advanced Model Development & Operationalization: Deep expertise in developing, deploying, and managing complex machine learning and deep learning algorithms at scale. This includes a profound understanding of model evaluation, scoring methodologies, and mitigation of model bias to ensure robust, ethical, and reliable outcomes. Data & Computational Proficiency: Fluent in Python or R and SQL, with hands-on experience in building and optimizing data pipelines for analytical and model development purposes. Cloud-Native AI/ML: Demonstrated experience with Cloud DevOps on AWS as it pertains to the entire data science lifecycle, from data ingestion to model serving and monitoring. Translational Research: Proven ability to translate foundational AI/ML research into functional, production-ready packages and applications that directly support strategic initiatives in areas like RWE, Clinical Pharmacology, and Biomarkers. Basic Qualifications: Doctorate and 5+ years of relevant experience OR Master's and 8+ years of relevant experience OR Bachelor's and 10+ years of relevant experience Preferred Qualifications: Ability to translate stakeholder needs into clear technical requirements, including those related to RWE, Clinical Pharmacology, and Biomarkers. Skill in scoping project requirements and developing timelines. Knowledge of product management principles. Experience with code management using Git. Strong technical documentation skills. Join us at the AI Research Center to shape the future of clinical development with groundbreaking AI/ML solutions, and contribute to advancements in RWE, Clinical Pharmacology, and Biomarkers! The salary range for this position is: Bay Area: $210,375.00 - $272,250.00.Other US Locations: $191,250.00 - $247,500.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Share: Job Requisition ID R0046852 Full Time/Part Time Full-Time Job Level Associate Director Click below to return to the Gilead Careers site Click below to see a list of upcoming events Click below to return to the Kite, a Gilead company Careers site #J-18808-Ljbffr
    $210.4k-272.3k yearly 5d ago
  • Cell Culture Process Development Lead - Pivotal & Commercial

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $92k-120k yearly est. 4d ago
  • Machine Learning Engineer - Devops

    Genentech 4.5company rating

    San Francisco, CA job

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. Advances in AI, data, and computational sciences are transforming drug discovery and development. Roche's Research and Early Development organisations at Genentech (gRED) and Pharma (pRED) have demonstrated how these technologies accelerate R&D, leveraging data and novel computational models to drive impact. Seamless data sharing and access to models across gRED and pRED are essential to maximising these opportunities. The new Computational Sciences Center of Excellence (CoE) is a strategic, unified group whose goal is to harness this transformative power of data and Artificial Intelligence to assist our scientists in both pRED and gRED to deliver more innovative and transformative medicines for patients worldwide. Opportunity At Roche\'s AI for Drug Discovery (AIDD) group (Prescient Design), we are revolutionizing drug discovery with cutting-edge machine learning techniques. We are seeking a highly motivated and skilled ML Infrastructure DevOps Engineer to join our growing team within Genentech Research and Early Development AI Drug Development (gRED AIDD). This role is crucial for building and maintaining the scalable and robust infrastructure that powers our machine learning initiatives. The ideal candidate will be proactive, user-facing, and possess a "get-it-done" attitude, while consistently adhering to corporate standards and best practices. Responsibilities Design, implement, and maintain scalable and reliable ML infrastructure on AWS. Automate deployment, monitoring, alerting, and operational tasks using tools like Terraform and Helm. Manage and optimize CI/CD pipelines and Git repositories for ML projects, ensuring efficient version control to support collaboration and deployment. Collaborate closely with ML engineers and data scientists to understand their infrastructure needs and provide solutions. Troubleshoot and resolve infrastructure-related issues in a timely manner. Implement and enforce security best practices for ML infrastructure. Document infrastructure designs, processes, and operational procedures. Contribute to initiatives independently as part of a team, delivering assigned outputs. Proactively identify issues and gaps, proposing ideas and suggestions for improvements. Who you are / Qualifications Proven experience in designing, deploying, and managing infrastructure on Amazon Web Services (AWS), including services such as EC2, S3, RDS, EKS, SageMaker, etc. Strong proficiency with Git and Git repository management. Hands-on experience with Terraform for infrastructure provisioning and management. Experience with Helm for deploying and managing applications on Kubernetes. Proficiency in scripting languages (e.g., Python, Bash) for automation. Excellent problem-solving skills and a strong ability to debug complex issues. Strong communication and interpersonal skills to effectively collaborate with cross-functional teams and user-facing interactions. Demonstrated ability to take initiative, anticipate needs, and drive projects to completion. Ability to thrive in a fast-paced environment and adapt to evolving requirements while adhering to corporate guidelines. Ability to write clean code with little syntax/convention feedback. Applies software engineering best practices (linting automation, unit testing, documentation, CI/CD). Familiarity with modern machine learning methods. Knowledge of and experience with high-performance computing, distributed systems, and cloud computing. Preferred Experience with MLOps platforms and tools. Familiarity with CI/CD pipelines for ML workflows. Knowledge of monitoring and logging tools (e.g., Prometheus, Grafana, ELK stack) Relocation benefits are available for this job posting. The expected salary range for this position based on the primary location of California is $147,600 - $274,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company\'s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr
    $147.6k-274k yearly 5d ago
  • Senior Oncology Bioinformatics Scientist

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    A leading biotech company in Foster City is searching for a Senior Scientist with extensive experience in analyzing omics data such as RNA-Seq and WES. The ideal candidate will have a PhD and 8+ years of experience in the pharmaceutical or biotech industry, strong statistics knowledge, and excellent communication skills. Responsibilities include synthesizing scientific questions into research efforts and empowering teams to achieve organizational objectives. Join a dynamic team that values diversity and supports professional growth. #J-18808-Ljbffr
    $88k-133k yearly est. 2d ago
  • Director, HIV Community Liaison & Marketing

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    A leading biopharmaceutical company in California is seeking a professional with strong marketing skills and an emphasis on HIV-related experience. The ideal candidate will work with external agencies and contribute to the development of impactful marketing programs. Applicants should have a bachelor's degree, extensive experience in marketing, and an ability to thrive in a fast-paced environment. The role entails collaboration, communication, and a sensitivity to the topics in the HIV market, with potential for domestic travel. #J-18808-Ljbffr
    $49k-62k yearly est. 2d ago
  • Director, Human Resources

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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. At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. We are seeking a Director, HR Business Partner to partner with the U.S. Commercial organization. The Director will act as a strategic HRBP to Senior Business Leaders and Commercial Vice Presidents adopting a business-focused approach to translate objectives into actionable people plans, emphasizing organizational design, talent management, and capability building. The Director will be a member of the respective business leadership teams and the Global Commercial HRBP team to drive and implement workforce strategies that facilitate business success, promote an inclusive and high-performing culture, and embody Gilead's core behaviors and leadership accountabilities. This role reports to the Executive Director of Human Resources for Gilead U.S. Commercial. This is a hybrid/office based role located in Foster City, California. Specific job responsibilities Directs the planning, development, implementation, administration and budgeting for a portion of a large client group, or a specific geographic area. Challenges are unique and solutions may serve as a precedent for future decisions. Provides support directly to senior management and defines the HR strategy for the client group or groups supported. Advises company management on HR policy and program matters, making or recommending appropriate decisions, which may be significantly complex. Initiates discussions regarding organizational changes and presents each of the HR specialty functional areas (training, compensation, benefits, etc.) when working with management. Within client group, facilitates the management and development of the corporate culture and values, and leads employee and manager engagement initiatives to foster teamwork and enhance employee engagement. Viewed as subject matter expert and maintains contacts with external sources to stay apprised of current trends and new legislative changes. Accomplishes results as an individual contributor or through HR subordinates or specialist employees/CoE. May select, develop and evaluate HR staff to ensure the efficient operation of the function. Develops concepts, techniques, and standards for flawless execution on the delivery of HR services including talent acquisition, performance management, talent reviews, compensation planning, and project management. Develops new applications based on professional principles and theories. Provides analysis and recommendations about the reengineering and optimization of the organizational structure, roles, process and resource allocation, and facilitates change management. Designs, develops and implements communication strategy using various media. Ensures effective communication strategies are in place within the organization and builds two-way communication channels. Proactively questions the decisions of management that impact the long-term direction of the client group. Provides coaching support for site or client group leadership, building skills, knowledge, and competencies to achieve results and make employee-related decisions in a fast changing environment. May be responsible for representing client group or site with labor unions and/or works councils to ensure compliance with relevant labor laws and a favorable climate with employee representative groups. May require strong business knowledge as well as a sophisticated understanding of labor relations and union negotiation rules. Knowledge 12+ years of relevant experience in the HR field and a BA or BS degree, preferably with an emphasis in HR or Business or 10+ years of relevant experience in HR with a master's degree. Works under consultative direction toward long-range goals and objectives. Assignments are self-initiated with very little direct supervision. Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills. Requires a thorough knowledge and understanding of Human Resources legislation/employment law, principles, policies, and procedures. Must be able to develop solutions to a wide range of highly complex problems, which require an in depth degree of ingenuity, creativity, and innovativeness. May require experience and ability to manage staff. Must be able to exercise judgment and independently determine and take appropriate action within defined HR policies and procedures. Specific education and experience requirements. 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. The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the ‘Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0049454 Job Level Director #J-18808-Ljbffr
    $210.4k-272.3k yearly 4d ago
  • Counsel, Commercial - Heart Failure

    Abbott Laboratories 4.7company rating

    Abbott Laboratories job in Pleasanton, CA

    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
    $84k-133k yearly est. 5d ago
  • Global Public Affairs Director: NGO & Stakeholder Engagement

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    A leading biopharmaceutical company is seeking an experienced leader in global public affairs to drive strategies for expanding access to medicines, particularly in low- and middle-income countries. The role involves building partnerships, managing communications, and developing initiatives with patient communities and stakeholders. Strong communication skills, analytical capabilities, and proven leadership are essential. Candidates should possess a relevant bachelor's degree, with a master's or MBA preferred. This role requires travel 30-40% of the time. #J-18808-Ljbffr
    $124k-157k yearly est. 4d ago
  • Senior FP&A Leader, Oncology Program Finance

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $121k-161k yearly est. 4d ago
  • Senior Demand Planner

    Abbott 4.7company rating

    Abbott job in Alameda, CA

    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: ************************************************************
    $86.7k-173.3k yearly Auto-Apply 58d ago
  • Associate Director/Principal Scientist

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $116k-163k yearly est. 4d ago
  • Senior Engineer, Process Engineering

    Astrazeneca 4.6company rating

    Redwood City, CA job

    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
    $97.4k-146.1k yearly 3d ago
  • Principal Regulatory Affairs Specialist - APAC - Diabetes Care (on-site)

    Abbott 4.7company rating

    Abbott job in Alameda, CA

    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 ******************
    $100k-200k yearly 60d+ ago
  • Director, Device Engineering

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    Director, Device EngineeringUnited States - California - Foster City Manufacturing Operations & Supply Chain Regular 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. Specific Job Responsibilities Build, lead, and inspire a high-performing team o f engineers, fostering a culture of collaboration, accountability, innovation, and continuous development within the device development function. Champion a systems-based approach to product development, ensuring that all combination products are treated as integrated systems encompassing drug, device, user interface, and delivery performance. Influence and collaborate effectively across the organization, including with clinical, regulatory, quality, commercial, and manufacturing teams, to align on product strategy, development priorities, and risk management. Reinforce and communicate the value proposition of drug-device combination products, advocating for user-centric design, differentiated delivery platforms, and the strategic role of devices in enhancing therapeutic outcomes. Ensure robust design control and risk management practices are followed across all device programs, in alignment with global regulatory requirements (e.g., FDA, EMA, ISO 13485, ISO 14971). Establish and maintain strong relationships with external partners and suppliers, ensuring alignment on technical requirements, timelines, and quality expectations. Required Education & Experience Bachelor's Degree and Twelve Years' Experience OR Masters' Degree and Ten Years' Experience OR PhD and Eight Years' Experience Preferred Experience Experience leading combination product development projects and managing device engineers . A Bachelor's Degree in Mechanical Engineering , Chemical Engineering, Biomedical Engineering, or a related scientific field and a minimum of ten (10) years of relevant industry OR a Master's Degree and a minimum of eight (8) years of relevant industry. Experience with the development and commercialization of combination products. Working knowledge of FDA, EMA, and cGMP standards for combination products. Strong verbal, written, and interpersonal communication skills . Able to write clear, concise, and error-free documents. Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action. People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modelling 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, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem 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 We are seeking a dynamic and people-focused Director of Device Development to lead a team of engineers in the design and delivery of parenteral drug-device combination products, including prefilled syringes and autoinjectors. This role is centered on building a strong team culture, fostering cross-functional collaboration, and reinforcing the strategic value of combination products as integrated product systems. The ideal candidate will be a skilled leader who can influence across the organization, drive alignment, and champion the role of device innovation in enhancing patient outcomes. This is a high-impact leadership position with a strong emphasis on team development, organizational influence, and strategic execution. Specific Job Responsibilities Build, lead, and inspire a high-performing team o f engineers, fostering a culture of collaboration, accountability, innovation, and continuous development within the device development function. Champion a systems-based approach to product development, ensuring that all combination products are treated as integrated systems encompassing drug, device, user interface, and delivery performance. Influence and collaborate effectively across the organization, including with clinical, regulatory, quality, commercial, and manufacturing teams, to align on product strategy, development priorities, and risk management. Reinforce and communicate the value proposition of drug-device combination products, advocating for user-centric design, differentiated delivery platforms, and the strategic role of devices in enhancing therapeutic outcomes. Ensure robust design control and risk management practices are followed across all device programs, in alignment with global regulatory requirements (e.g., FDA, EMA, ISO 13485, ISO 14971). Establish and maintain strong relationships with external partners and suppliers, ensuring alignment on technical requirements, timelines, and quality expectations. Required Education & Experience Bachelor's Degree and Twelve Years' Experience OR Masters' Degree and Ten Years' Experience OR PhD and Eight Years' Experience Preferred Experience Experience leading combination product development projects and managing device engineers . A Bachelor's Degree in Mechanical Engineering , Chemical Engineering, Biomedical Engineering, or a related scientific field and a minimum of ten (10) years of relevant industry OR a Master's Degree and a minimum of eight (8) years of relevant industry. Experience with the development and commercialization of combination products. Working knowledge of FDA, EMA, and cGMP standards for combination products. Strong verbal, written, and interpersonal communication skills . Able to write clear, concise, and error-free documents. Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action. People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modelling 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, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Share: Job Requisition ID R0045917 Full Time/Part Time Full-Time Job Level Director Click below to return to the Gilead Careers site Click below to see a list of upcoming events Click below to return to the Kite, a Gilead company Careers site #J-18808-Ljbffr
    $210.4k-272.3k yearly 6d ago
  • Senior Medical Science Liaison, Immunology - Territory Lead

    Johnson & Johnson 4.7company rating

    San Francisco, CA job

    A global healthcare leader is seeking a Senior Medical Science Liaison in San Francisco to provide scientific support and engage with healthcare professionals. This role requires strong scientific acumen and at least 3 years of experience in the therapeutic area. The Sr. MSL will build external relationships, develop strategic plans, and may travel up to 80%. If you are passionate about enhancing patient care and have relevant qualifications, apply to drive innovations in immunology. #J-18808-Ljbffr
    $119k-162k yearly est. 6d ago
  • Technical Application Specialist - Western U.S

    Abbott 4.7company rating

    Abbott job in San Francisco, CA

    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. 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. 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 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 Abbott Diagnostics Division is looking for a Technical Application Specialist in our US West Coast territory. They will provide support to customers and field personnel as the primary contact for ADD's highest complexity instruments for onsite instrument and assay integration and training; and serve as a resource for internal/external customers in troubleshooting and resolving instrument and/or reagent problems onsite or over the phone; and document information into the complaint handling system. Territory This is a remote field-based role. Qualified candidates must currently live on the West Coast of the US (CA, PNW, UT, etc.), preferred locations- San Francisco/Sacramento, CA, Reno, NV, Salt Lake City, UT, Las Vegas, NV 90% travel, 75%-90% will be overnight travel What You'll Work On Responsible for implementing and maintaining the effectiveness of the quality system. Lead multi-site/multi-instrument integrations for ADD instruments and reagents into customer sites/laboratories, including new product launch (NPL) products. Conduct a comprehensive customer entrance interview to understand the customer's needs and manage their expectations within the defined service offerings. Plan the on-site integration process. Work with implementation project managers as technical lead to execute the project plan across customer systems. Work with the customer to take ownership of the instrument. Assist customers with meeting their regulatory and validation requirements. Provide appropriate training for the customer on the newly installed instrument. Manage the integration process to meet customer expectations and timeline. Conduct a thorough exit interview to present integration results and secure customer buy-in. Lead critical account management situations as part of a combined sales/service/support effort. Perform troubleshooting on issues related to reagent or instrument performance designed to improve customer self-sufficiency. Provides technical phone and on-site support to proactively maintain product performance or resolve customer complaints with ADD products for hardware, software, and reagent issues. Investigate problems; diagnose probable causes; systematically eliminate alternatives; provide solutions; document information into the complaint handling system. Position is critical to the support of the CAPA Quality Sub-System, with responsibility for accurate documentation of customer complaints and the actions taken to resolve those concerns. Recognizes and communicates product issues and potential improvements to others in the organization in a timely and effective manner. Provide immediate feedback to CSO, GSS, and others regarding NPL field performance. Deliver onsite or classroom-based customer training. Customize onsite training to meet specific customer needs. Maintain and develop technical competence on instruments assigned as well as job-related tools and processes. Consults in the sales cycle regarding integration/technical/workflow issues, and the service cycle on HSI or other account management issues. Manage time, territory, systems, and accounts effectively to meet customer needs, organizational priorities, and sales objectives. Follow defined TAS work processes for all aspects of the job, including integration procedures, complaint documentation, time documentation, activity documentation, and TOR documentation. Provide data to the organization on customer use/preferences, leading to customer-driven design/customer usability. Responsible for identifying and communicating critical gaps and recommending potential improvements to cross-functional work processes. Function as SME or point-person on complex processes on cross-functional teams. Provide technical information to direct management/peers and other functional groups. This position is very visible to the external customer and will influence customer purchase decisions. This position is a Subject Matter Expert (SME) for the Technical Application Specialist (TAS) organization, covering sales and service, influencing stakeholders in these areas. Frequent interaction with customers onsite and via telephone; SME/leadership roles on teams or major projects. Leadership shared with Field Service, CSC or others on critical account management issues. Receives general direction and exercises considerable discretion as to personal work details. Accomplishes results individually, working remotely and in collaboration on teams and work groups. Develops processes and procedures for the department. Recognizes the impact of the policies and procedures on the business and raises the issue if there is a potential conflict. Makes decisions on reagent utilization on integrations and troubleshooting product replacement that impacts the annual supply budget. Considers financial and customer implications as part of decision-making. Critical contribution to the effectiveness of the CAPA system with responsibility for accurate documentation of customer complaints and the actions taken to resolve those concerns. Exhibits a high level of integrity, honesty, keeping commitments, and presenting information completely and accurately to both internal and external customers. Monitor and maintain customer satisfaction through direct contact. Adheres to safety guidelines, policies, and procedures. Required Qualifications Bachelor's degree in clinical laboratory, Science or Medical Technology, Biology/Chemistry, or other similar healthcare degrees with an emphasis on the clinical laboratory. 5+ years' experience in la aboratory environment, field service, technical call center, or Abbott Diagnostics products Preferred Qualifications Bachelor's degree in medical technology 5+ years' experience in a laboratory environment, field service, technical call center, or Abbott Diagnostics products. 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 $61,300.00 - $122,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Support ServicesDIVISION:CRLB Core LabLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 75 % 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), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment 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: ************************************************************
    $61.3k-122.7k yearly Auto-Apply 9d ago
  • Global Study Director

    Astrazeneca 4.6company rating

    San Jose, CA job

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge‑sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face‑to‑face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategise, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Introduction to role Are you ready to lead the charge in groundbreaking clinical studies? As a Global Study Director (GSD), you will play a pivotal role in the Cell Therapy Clinical Operations organization, driving the operational planning and delivery of high‑priority and complex clinical studies. Your expertise will ensure the successful execution of clinical trials, managing quality, timelines, budgets, resources, investigational sites, vendors, and key project deliverables. Leading a cross‑functional study team, you will provide direction and guidance to achieve study milestones. Collaborate with internal and external stakeholders to resolve issues and ensure compliance with SOPs, regulatory requirements, and ICH/GCP guidelines. Your leadership will extend to mentoring GSADs and spearheading non‑drug programs and improvement projects. Accountabilities Lead and coordinate a cross‑functional study team to ensure clinical study progress according to timelines, budget, and quality standards. Contribute to vendor/ESP selection activities and lead operational oversight at the study level. Assist with operational planning for upcoming clinical studies, interfacing with cross‑functional partners. Collaborate to establish strategies for increasing efficiency of global study teams. Facilitate communication across functions and provide guidance to study team members. Serve as the primary AZ contact for outsourced studies, ensuring delivery according to agreed standards. Hold accountability for essential study level documents development. Ensure external service providers perform to contracted goals and timelines. Develop and maintain relevant study plans, including risk management planning. Oversee study level performance against plans, milestones, and KPIs. Identify and report quality issues within the study and collaborate to overcome barriers. Ensure Trial Master File completion and compliance with governance controls. Manage study budget through lifecycle and provide progress reports. Ensure studies are inspection‑ready at all times. Support professional development of team members. Provide guidance and mentoring to less experienced colleagues. Lead non‑drug project work and improvement projects. Essential Skills/Experience University degree or equivalent in medical or biological sciences or discipline associated with clinical research. Proven project management experience and training. At least 7 years of clinical trial experience. At least 3 years of experience in global study leadership and team leadership. Demonstrated clinical trial expertise in hematology and/or oncology. Extensive knowledge of ICH‑GCP guidelines and clinical research regulatory requirements. Thorough understanding of the cross‑functional clinical trial process. Strong strategic and critical thinking abilities. Proven skills in complex problem solving and decision‑making. Strong abilities in establishing effective working relationships with senior stakeholders. Demonstrated abilities in mentoring. Excellent communication and interpersonal skills. Ability to manage multiple competing priorities. Experience in external provider oversight and management. Desirable Skills/Experience Advanced degree, masters level education or higher. Project management certification. 5 years of experience in global study leadership and team leadership. Significant hematology/oncology expertise. Expertise in different phases of clinical delivery. Experience with project management software solutions. Cell therapy/CAR‑T experience. Global phase 3 study experience. Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn: ************************************** Follow AstraZeneca on Facebook: ******************************************** Follow AstraZeneca on Instagram: **************************************************** Our US Footprint: Powering Scientific Innovation - YouTube The annual base pay (or hourly rate of compensation) for this position ranges from $162,566.4 to $243,849.6 USD. 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. AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing *********************************. AstraZeneca offers an environment where you can be empowered to make bold decisions and move at pace. With a focus on Oncology, we are driven by speed and backed by leadership that empowers every level to prioritize smart risks based on scientific evidence. Our scale, agility, and passion ensure fast delivery every time. Join us in pioneering new frontiers in cancer research, where courage, curiosity, and collaboration drive patient outcomes. Be part of a team committed to improving the lives of millions with cancer. Ready to take on this exciting challenge? Apply now to join our dynamic team! #LI-Hybrid Date Posted 16-Jan-2026 Closing Date 29-Jan-2026 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
    $162.6k-243.8k yearly 2d ago
  • Sr. Clinical Engineer

    Abbott 4.7company rating

    Abbott job in Pleasanton, CA

    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 We are seeking an experienced, high caliber Senior Engineer to support product development efforts by performing clinical engineering tasks such as investigating, defining, analyzing, documenting, and testing activities associated with the development of heart failure devices. Clinical Engineering performs additional analyses and/or interviews to determine the requirements and constraints on the system and is accountable for resolving cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity, and creative/analytical techniques. What You'll Work On : Represent clinical engineering on heart failure product development projects. Support product development efforts by performing clinical engineering tasks such as defining, investigating, analyzing, testing, and documenting activities associated with development of specific products Leverage clinical and product expertise to aid new concept and product development, define preferred embodiments of products, features, and algorithms, and evaluate compatibility of system components in clinical workflow scenarios Investigate and define clinical and human factors requirements for new devices and system features, drive integration of features into the existing clinical workflows, and facilitate the transition of these features into products through clinical review and evaluation Plan and execute feasibility studies, pre-clinical testing, technology assessments, benchmarking, and concept evaluations to inform design decisions. Develop expertise in the scientific, technical, medical, and clinical aspects of Abbott heart failure devices and features and the disease states they adresss Contribute to the risk management process, including risk brainstorming, identification of Patient Harms, and severity and probability assessments Develop and lead clinical validation plans and activities, ensuring robust evidence for product performance and safety. Contribute to the evaluation and validation of a specific subsystem, system, or product prior to submission Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Required Qualifications Bachelor's Degree in an Engineering discipline (Biomedical, Systems, Electrical, Mechanical, Software) or related discipline Minimum of 5 years of R&D experience in medical device development and/or other highly regulated industry. (Advanced degree may substitute for some experience.) Demonstrated ability to apply an expert understanding of clinical applications to issues in order to bring tasks to resolution within assigned projects Demonstrated ability to effectively integrate information from to varied disciplines including Engineering, Marketing, Clinical Affairs, and Regulatory Affairs. Demonstrated leadership in team settings, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results Preferred Qualifications Advanced level degree in an Engineering discipline (Biomedical, Systems, Electrical, Mechanical, Software) or related discipline Class III implantable medical device experience Demonstrated ability to apply understanding of clinical application to issues in order to bring tasks to resolution within assigned projects. Excellent interpersonal and communication skills (verbal, written, presentation), with ability to clearly communicate complex information across all levels of the organization Strong analytical, problem-solving skills Ability to leverage and/or engage others to accomplish projects Ability to work in a highly matrixed, geographically diverse, fast-paced business environment 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. The base pay for this position is $75,300.00 - $150,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Product DevelopmentDIVISION:HF Heart FailureLOCATION:United States > Burlington: 23 Fourth AvenueADDITIONAL LOCATIONS:United States > Pleasanton : 5000 Franklin DrWORK 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) 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: ************************************************************
    $75.3k-150.7k yearly Auto-Apply 42d ago

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