Beckman Coulter Diagnostics

Lead product lifecycle management for immunoassays, translating customer insights into product strategies, and collaborating across teams to ensure compliance and market success. | 7+ years of relevant experience, proven track record in product development strategies, and experience in diagnostic or medical device industry preferred. | Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Innovation Product Manager, Immunoassay, is responsible for Immunoassay and Reagent Solutions. This position reports to the Senior Director, Product Management, within the Clinical Chemistry & Immunoassay Business Unit located in Chaska and will be an on-site role. However, qualified candidates not located near Chaska will be considered and the role may be filled as a remote role. At Beckman Coulter, our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time. In this role, you will have the opportunity to: • Lead product lifecycle management for immunoassays, ensuring alignment with business unit goals and the CCIA customer needs. • Partner with Sales and Marketing to gather voice of customer (VoC) insights and translate them into actionable strategies for portfolio development. • Establish leadership in cross-functional New Product Development core teams and ensure adherence to market and product requirements from pre-concept tollgate and through product development cycle. • Analyze financial performance, market trends and customer feedback to inform roadmap decisions and strategic planning. • Support cross-functional teams in resolving product issues and ensuring regulatory and quality compliance. The essential requirements of the job include: • Bachelor’s degree in Science, Business or related field, with 7+ years of relevant experience OR Master’s degree with 5+ years of relevant experience • Track record in developing new product development strategies and roadmaps • Performing market and customer insight research to deeply understand customer needs, challenges and translate these together with a cross-functional team into diagnostic solutions • Leading projects with risks and complexity, collaborating with cross-functional teams of R&D, global/regional marketing, regulatory, clinical, quality and operations. It would be a plus if you also possess previous experience in: • MBA degree • Related experience with immunoassay products • Medical device industry or IVD regulated environment Travel, Motor Vehicle Record & Physical/Environment Requirements: • Ability to travel 10-15% Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide. The annual salary range for this role is $130,000 - $170,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. #LI-AY1 Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.

Plan and execute clinical trial and vendor audits, manage clinical quality issues and CAPA processes, provide compliance training, and ensure regulatory readiness. | Bachelor's degree with 6+ years clinical quality experience in diagnostics or medical device industry, 4 years clinical quality auditing experience, and deep knowledge of relevant ISO standards and regulations. | Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Within Danaher the work our diagnostic businesses do saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives. Learn about the Danaher Business System which makes everything possible. This position is part of the Danaher Diagnostics organization and is a remote role. At Danaher Diagnostics, our vision is to be the leading provider of seamlessly connected diagnostic solutions. The Staff Clinical Compliance Auditor (Global Focus - Remote) for Danaher Diagnostics is responsible for clinical quality and compliance. This includes study audit and inspection management activities across the Clinical Center of Excellence (CCOE). You will be a part of the Clinical Compliance team and report to the Sr. Director of Global Clinical Compliance responsible for clinical quality and scientific writing to support new product research across four diagnostic operating companies within Danaher Diagnostics. If you thrive in a fast-paced, high impact role and want to work to build a world-class audit-ready Clinical organization—read on. In this role, you will have the opportunity to: • Plan and execute internal audits of clinical trials, sites, vendors, and systems, and support external audits or regulatory inspections. • Lead a comprehensive schedule of audits to ensure Bioresearch Monitoring (BIMO) inspection and notified body (NB) audit readiness. • Lead the investigation of clinical quality issues, deviations, and non-conformances, managing the CAPA process to ensure effective resolution. • Provide expert guidance and training to clinical study teams and other relevant staff on compliance requirements, best practices, and the clinical QMS. • Monitor changes in relevant regulations and guidelines, assessing their impact on clinical operations and updating internal procedures accordingly. The essential requirements of the job include: • Bachelor's degree with 6+ years clinical quality experience within diagnostics or medical device industry, or Master’s or Doctoral degree with 4 years of the same experience. • 4 years of clinical quality auditing experience or a combination of clinical project auditing and clinical study experience. • In depth understanding of ISO 14155, 13485, 14971, 20916, in vitro diagnostic regulation (IVDR), medical device regulation (MDR), and pertinent sections of 21 CFR. • Highly motivated to work in a fast-paced environment with effective use of prioritization, organization, problem-solving and time management skills. It would be a plus if you also possess previous experience in: • Certified auditor (e.g., ASQ CQA or ASQ CBA, GCP) • The technology and assays related to in vitro Diagnostic (IVD) across one or more of the following areas: chemistry, immunoassay, hematology, microbiology, or flow cytometry. Danaher Diagnostics, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. Within Danaher Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working within Danaher Diagnostics can provide. The annual salary range OR the hourly range for this role is $115K-$135K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.

Lead and develop Danaher Business System innovation and continuous improvement strategies across product portfolios, mentor teams, and drive strategic initiatives including portfolio roadmap and kaizen events. | Requires 18+ years in product development with leadership experience, mastery of innovation and continuous improvement tools, strong communication and project management skills, and preferably medical device and regulated quality system knowledge. | Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Sr Director, Innovation Danaher Business System (Continuous Improvement) drives global Danaher Business System (DBS) capability and continuous improvement across the Beckman Coulter Diagnostics product portfolio and product lines. This role partners with the Chief Portfolio Officer and Business Unit leadership to develop and execute long- and short-term DBS strategies. Responsibilities include leading DBS Innovation processes and tools for Strategic Innovation Review, Product Planning Group, and new product development programs. This individual also implements the DBS Innovation Roadmap, focusing on closing maturity gaps and building competitive advantage. This role reports into the VP of Strategic Initiatives and DBS. This job is a remote role, based in the USA. In this role, you will have the opportunity to: • Implement Danaher Innovation Playbook across Beckman Coulter Diagnostics to drive DBS maturity across the organization. • Develop DBS Road Map and Action Plan to drive organization maturity Implement and sustain Danaher Innovation processes and tools including Strategic Innovation Review and Product Planning Group. • Lead, mentor and develop direct reports or Danaher Business System Leader (DBSL) practitioners with both formal and informal DBS training and coaching. • Drive key programs and strategic initiatives by being an active Leader in VPM installation, Kaizen’s, PSPs and Daily Management reviews (as appropriate). • Lead the annual Portfolio rationalized roadmap and budgeting process. • Help Danaher continue the evolution of the DBS tools (main contact here is Danaher Business System Office). • Ensure successful kaizen events by installing and ensuring compliance with the kaizen process (includes; (1) planning of kaizens with a dynamic funnel process tied to PD and Daily Management, (2) kaizen execution and (3) sustainment of kaizens). The essential requirements of the job include: • Bachelor’s degree in Business, Science or Engineering and 20+ years of experience in Product Development – OR - a Master’s degree preferred and 18+ years of Product Development experience with 4+ years of leading a team of direct reports. • Ability to accurately assess key business metrics and situations from a “General Manager’s” point of view. • Ability to design, develop, and implement Innovation Danaher Business System roadmap for Beckman Coulter Diagnostics. • Mastery of a variety of Innovation and Fundamental DBS or similar Continuous Improvement tools. • Demonstrated proficiency in time and project management. • Superior communication, training, consulting and influencing skills. Able to “influence without direct authority.” • Good communication skills, including computer skills. It would be a plus if you also possess previous experience in: • Medical device product development • Regulated Quality Management System – e.g. FDA CFR 820, EU ISO-13485 Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide. The annual salary range for this role is $240,000 – $270,000 USD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com. Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.