B. Braun Medical jobs in Fremont, CA

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health ™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. About the role: In this role you will partner with the product owner on projects, and the overall cross-functional team, to support the successful global launch of a key initiative for bdbiosciences.com. You will lead projects aimed at improving customer experience through the eBusiness channel including web, e-commerce, B2B, punchout and other digital channels. You will also support the team that leads multiple related but distinct projects, with members of marketing, IT, shared services (legal, regulatory, etc.), and external vendors to ensure seamless execution of all phases through launch. Key responsibilities include: Works with product owner and other functional leaders to ensure the appropriate core team resources and the external strategic partners are committed to the projects and supply to the expected levels. Develops detailed program/project execution plan, and manages implementation processes including financials, progress tracking, metrics, monitoring change control process, testing, release to production and on-time delivery within budget constraints. Provides overall communication and works with all areas affected by the program/project. Drives the team to project completion ensuring that we are creating best-in-class product and service experiences. Coordinates cross-team dependencies or participate in Scrum of Scrums, if applicable. Provides regular status updates, dashboards, and reports to leadership. Improves project workflows, documentation, and team productivity. Identifies opportunities for automation, process optimization, and better team coordination. Facilitates all scrum ceremonies: Daily Stand-ups, Sprint Planning, Sprint Review, and Sprint Retrospective. Ensures Scrum events are efficient, valuable and time-boxed. Facilitates coordinate and track UAT for major enhancements and projects. Builds a safe and trustful environment with an emphasis on problem-solving and psychological safety. About you: To succeed in this role, someone needs to be highly organized and skilled at managing complex projects across multiple teams, with strong communication and collaboration abilities. They should be comfortable working in an Agile environment as a Scrum Master, able to remove obstacles, keep projects on track, and ensure seamless execution. A focus on customer experience and digital solutions is essential, along with adaptability to handle competing priorities in a fast-paced global setting. Required education and experience Bachelor's degree in computer science, Engineering, Information Systems, or related field First or second level Scrum Master (CSM, ACSM, PSM I/II) or Certified Scrum Professional (CSP) At least 4 years of experience in technical project management, program management, or related technical roles Expert-level knowledge of JIRA and Confluence, with the ability to customize them based on project needs Experience working with Agile, Scrum, or Kanban methodologies. Experience with Agile traits and techniques: Lean design, accommodating changing requirements, iterations, loop feedback with customer involvement. Demonstrated consistent ability to lead cross-functional teams and deliver technical solutions while mitigating or removing hurdles / obstacles. Proven a track record of overcoming project crisis. Ability to lead cross-functional leadership in a global, fast-paced, matrix organization. Strong analytical and problem-solving skills. Preferred qualifications: Ecommerce experience highly preferred Technical knowledge preferred At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. --- Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of our health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - Milpitas 155Additional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Job Description Your Role At Baxter: Incumbent is responsible for Day-to-day activities of Quality Operations, Quality Assurance, Inspections/Release, Compliant Investigations and NCRs/ CAPA's, cGMP compliance and Inspection readiness by ensuring quality and compliance are built into day-to-day operations. Your team Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. What You'll Be Doing Implementation and improvement of Quality Processes that will ensure compliance with Regulations, Corporate and Local procedures, and specifications. Quality Representative in the manufacturing areas. Manage the batch review and release activities. Interfaces with regulators during regulatory inspections/ audits. Identifies and manages continuous Improvement and VIP projects with the objective of achieving quality, reliability, and cost Improvements. Ensure adherence to budget. Support change control activities for manufacturing operations. Manage the release process, inspection, and batch release activities. Oversee, initiate, investigate and approve non-conformance report activities as needed. Promote a zero-harm workplace and ensure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees. Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvements. Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility. Interacts frequently with all levels of internal management as well as across functions and franchises. Manages overall coaching, training, development, and succession plans for the team. What You'll Bring BS in science or engineering. 5+ years' experience in Quality, Manufacturing, Engineering, or related field which should include 1-2 years of supervisory experience in a Medical Device or Pharma Industry. Thorough knowledge of applicable procedures, specifications, regulations, and standards. Strong leadership skills and demonstrated success in managing mid-to-large teams. Capable of managing in matrix and ability to interact successfully with multi-functions globally. Strong analytical and problem-solving skills. Ability to manage/supervise a team of employees. Good communication and leadership skills. Good interpersonal/communication/influencing/negotiation skills. Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Be part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.Duties and Responsibilities:Develops, revises, and reviews product package inserts and user's manuals to ensure compliance/conformity with existing Corporate, Regulatory and Global (ISO, PAL, etc.) guidelines.Develops, revises and reviews product package labeling (carton labels, component labels, package inserts and users' manuals) to ensure compliance/conformity with existing Corporate, Regulatory and Global (ISO, PAL, CE, etc.) guidelines.Works with internal teams (R&D, Marketing, Quality, Medical, Regulatory, and Plant production teams) to obtain an in-depth understanding of the product and the documentation requirements.Writes and/or prepares technical software documentation.Studies and reviews manufacturers' data, drawings, parts lists, and prototypes to delineate technology, operating procedures, and specific logistics of operation.Collaborates the development or revision of product documentation/digital content to determine specifications for: type style, font size, clarity and conformity of wording, formatting, topic-based order, and printing deliverables.Works with Incoming Inspection, Operations, and Quality to resolve issues regarding technical documentation and to develop procedures geared toward minimizing and eliminating recalls related to technical information.Creates and maintains multiple information architecture outputs.Analyses existing and potential content, focusing on reuse and single-sourcing opportunities.Develops and reviews Bill of Materials, vendor specifications for technical documentation, and develops and maintains graphic standards for manuals and digital content.Participates in the product development process and sustaining activities. Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business unit and plant projects to meet established goals.Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements; participates as required in training on regulatory issues affecting own area of work; brings regulatory compliance questions/issues to the attention of management.Qualifications:Bachelor's degree in English or related field with a minimum of five years of experience in technical writing and a minimum of two years of experience managing digital content projects; or equivalent combination of related education and experience. Ability to lead and participate in group projects, act as a team leader, develop project timelines, communicate effectively, and implement projects. Ability to handle multiple projects with excellent follow-up skills. Detail-oriented and have the ability to work under deadline pressure; must be able to deal with unresolved situations, frequent changes, delays, or unexpected events. Ability to perform spreadsheet and database maintenance for reporting the status of projects to management. Strong interpersonal and oral communication skills. Demonstrated proficiency in technical writing and editing for print and digital content. Functional knowledge of Microsoft Office Suite (MS Word, MS Excel). Demonstrated proficiency in DTP software applications (Adobe InDesign, Adobe FrameMaker, Adobe Illustrator).Knowledge of digital content software applications such as MadCap Flare or RoboHelp is required. Able to travel domestically and internationally up to 10%.For many roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates.To learn more about BD visit *************************** Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Additional Information All your information will be kept confidential according to EEO guidelines.

SummaryThe EHS Specialist II supports daily environmental, health, and safety (EHS) operations at the Milpitas and Montecito site. This role helps implement EHS programs, conducts training and inspections, and collaborates with cross-functional teams to promote a culture of safety and compliance. The position also assists in hazard identification, waste management, and supports incident prevention efforts. This individual collaborates cross-functionally to help maintain a safe and compliant workplace. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English. Willing and able to uphold BD Values. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Responsibilities include but are not limited to: Conduct routine EHS inspections and audits and follow through on identified remedial actions. Support EHS training and documentation. Support incident investigations and track corrective actions. Coordinate waste management and hazardous material handling. Support risk assessments and ergonomic evaluations. Assist in maintaining EHS management systems including but not limited to regular updates to EHS controlled documents. Ensure compliance with OSHA, EPA, DOT, and Cal/OSHA regulations within assigned business function(s). Collaborate with Operations and Facilities to mitigate EHS risks. Commute and work out of the Montecito campus at least once a week. Support emergency response and evacuation drills across the Milpitas and Montecito campuses. Support and participate in EHS campaigns and activities. Serve as the EHS business partner to assigned functional unit(s); supporting EHS programs including but not limited to EHS change management, etc. Other duties as to support the needs of the business. Minimum Education: This position has the following educational requirements: Required : Bachelor of Science in Environmental, Health, and Safety or any other related field. Preferred: Certifications such as NSC - Advanced Safety Certificate, BCSP - ASP, etc., is a plus or ability to obtain them within 2 years of hire date. Minimum Experience: A minimum of 1- 3 years of EHS experience in highly regulated environments (medical device, pharma, or biotech preferred). Demonstrated experience in leading EHS programs. Knowledge of regulatory compliance and EHS systems preferred Basic or simple knowledge: Hazard identification PPE Use Base EHS metrics Proficient/working: Microsoft office EHS management software or applications (Intelex, iAuditor, Smartsheet, SAP, Articulate 360, etc.,) Computer skills Incident investigation Risk assessment Advanced or specialized: Strong communication skills Root cause analysis Training delivery Regulatory interpretation Analytical skills Problem solving skills Work Environment: Safety culture, policies, and practices that ensure an increasingly safe work environment for all associates. Measurable improvement in safety performance on both incident rates and other measures. Site compliance with applicable federal, state, local and corporate regulations. Regulatory safety and environmental compliance. Effective safety and environmental projects and programs. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - Milpitas 155Additional LocationsUSA CA - San Jose - MontecitoWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $91,600.00 - $151,100.00 USD Annual

SummaryThe Field Service Engineer is responsible for successfully completing required training on BD products and participating in field practical training as preparation for customer account assignments within an assigned territory. This position is a field based position, but will require work both in the local office as well as at customer sites throughout the US as needed. The Field Service Engineer is required to maintain schedules for preventative maintenance inspections and installations, and respond to all repair activities for warranty and post-warranty instruments as assigned. The Field Service Engineer must successfully troubleshoot, repair and verify instrument performance on all activities and completes instrument installations, field updates, preventative maintenance inspections and all required field reporting in a timely manner. This position may also be required to provide service support outside their assigned territory. This position requires timely and accurate submittal of administrative duties including FSRs, expense reports and payroll forms. The Field Service Engineer works to ensure customer satisfaction through quality workmanship, documentation, customer management and demonstrates professionalism that is consistent with Becton Dickinson's image. This position must comply with Quality, GMP, ISO and safety regulations and adheres to company travel expense policies.Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Responsibilities: Successfully completes all formal training on core clinical and/or research BD products as required by territory assignment. Capable of interpreting instrument performance verification data used as an indicator of instrument optimization and takes corrective action when required. Repairs instruments of moderate complexity by troubleshooting, repairing and ensuring an acceptable level of instrument performance is achieved and with limited assistance. Works toward repair metrics as defined by the Service Organization and within the scope of the position. Schedules and performs installations, preventative maintenance inspections, reliability updates and works to achieve measurable goals for these activities as set by the Organization. Manages customer satisfaction by instilling confidence in BD Biosciences' products and services through quality workmanship and professional characteristics consistent with the BD image. Maintains a professional image at all times through dress, behavior, oral and written communications. Qualifications Required: A minimum of 3 years' experience troubleshooting instruments or components A valid Driver's License A minimum of a High School Diploma Must be able to travel a minimum of 50% Preferred: Flow Cytometry experience is a plus Technical military training Associates or Bachelor's degree in Electronics, Engineering, or other related technical or biological discipline Prior Field Service Engineer experience Individuals with previous experience troubleshooting medical device instruments Previous customer interfacing role Proficiency with MS Office applications such as Word and Excel Familiarity with recent Mac and PC operating systems Experience with tools and test equipment such as digital volt meters and oscilloscopes desirable At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. #earlycareer Required Skills Optional Skills . Primary Work LocationUSA CA - Milpitas 155Additional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $24.90 - $38.70 USD Hourly

Job DescriptionBe part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. Job responsibilities:Develop and execute international regulatory strategy for the successful registration of in vitro diagnostic (IVD) devices in markets outside of US and EU. Negotiate and establish product submission priorities that are aligned with IVDR priorities and region/country needs.Understands and interprets EU and international in vitro diagnostic (IVD) device regulatory requirements.Generate, coordinate, and manage regulatory submission documents for new products, renewals, or changes to existing products; ensure compliance with global regulations and guidelines. Coordinate responses to regulatory agencies as part of the submission and approval process.Represent RA in cross-functional product development teams to provide guidance on global regulatory strategies.Support change management by evaluating design, manufacturing and process changes for regulatory impact globally.Review Analytical and Clinical protocols to assure collection of appropriate data for regulatory submissions. Review/ Approve labels, labeling, and promotional materials for compliance with applicable regulations and policies. Develop and maintain procedures and/or work instructions for product registrations.Provide regulatory support during internal and external audits.Submit and maintain laser registrations for all instruments (IVD and RUO) when needed.Manage, monitor and track International product registration in Regulatory Information Management (RIM) database to ensure up to date information.Additional activities as needed to support RA goals. Minimum Qualifications:Education and Experience:Bachelor's degree required, strongly preferred in the biological sciences, chemistry or related science.Minimum 3 years' experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs. Tech file preparation and approval experience a plus.Ideal candidate will have demonstrated ability to interpret new regulations, and understand and interpret in vitro diagnostic device (IVD) regulatory requirements.Current knowledge of in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); and European quality system standards. Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization. Strong Project Management experience desirable, ability to prioritize, multi task, and organize work.For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit ******************** Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Additional InformationAll your information will be kept confidential according to EEO guidelines.

Job DescriptionBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.Primary Duties and Responsibilities: Conjugate various fluorochromes or organic compounds onto purified monoclonal antibodies and reagents by established procedures.Monitor conjugation processes at several stages. Select appropriate fractions to maximize yield and quality of product.Investigate and develop new methods and technologies for projects and process advancements as defined by senior chemist.Prepare technical reports, summaries, and quantitative analyses of assigned research projects.Tabulate and analyze data for all phases of a research project utilizing statistical software packages.Prepare protocols for simple experiments under supervision.Prepare and revises Standard Operating Procedures (SOP) and other documentation. Submit proposed revisions to senior chemist for review and approval.Maintain meticulous records of all results.Maintain assigned equipment and related logs and records.Purifies monoclonal antibodies from serum/ascites fluid and tissue culture supernatant by appropriate serum fractionation and /or column chromatographic techniques.Monitors purification processes at several stages to maximize yield and degree of purity of antibody.Keep abreast of the basic requirements for compliance in own area of work and comply with those requirements. Participate as required in training on regulatory issues affecting own area of work. Bring regulatory compliance questions/issues to the attention of management.Promote a safe work environment. May provide recommendations on maintaining the safety of work environment. Participate in Environmental Health and Safety programs. Address corrective actions whenever a hazard is identified. notifies managers of all observed hazardous conditions or unsafe work practices.Perform other related duties and assignments as required.Minimum Requirements:Bachelor's Degree5 Year's Lab experience For many roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit ******************** Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Additional InformationAll your information will be kept confidential according to EEO guidelines.

SummarySupports manufacturing & R&D operations. Performs equipment calibration, maintenance, troubleshooting, repairs, execute validations for new equipment installations, provides training on calibration, maintenance process as needed. Develops new calibration methods and procedures. The Calibration Technician is responsible for following the calibration department's SOPS & applicable calibration procedures, completing the monthly scheduled calibration/maintenance, work & work requests. Reports directly to QA ManagerJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. DUTIES AND RESPONSIBILITIES Independently calibrates, test and measuring equipment used in manufacturing BD Milpitas Campus. Follows local calibration procedures or manufacturer's instruction Perform minor repairs as needed. Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements as needed. Efficiently manage scheduled calibration activities and work requests, prioritizing work accordingly. Maintains accurate calibration documentation and data entries to BMRAM (Calibration Database) system. The daily tasks performed by this position are critical to the assurance of quality produced product. Errors or oversights made can affect six months to one year's worth of product. OTHER KNOWLEDGE AND SKILLS Previous employment in a Metrology Labs. Thrives in a team environment/collaborates effectively with colleagues Must have experience/knowledge with the duties/responsibilities described above. Must possess a thorough understanding of Calibration & Metrology principles and their relationship to Current Good Manufacturing Practices. Must have in-depth, detailed knowledge of the metrology, mathematics, and applicable technical disciplines required to perform the described duties. Must be familiar with mathematical calculations / concepts such as significant figures, rounding, averages, standard deviation and unit conversions Has completed Training or Certification Courses in calibration and repairs, or similar, is strongly desired. Experience in the equipment validation process - execution of tests Must be organized Computer & web-savvy Must possess good troubleshooting / problem solving skills Must possess good written and verbal communication skills Basic computer skills including the use of Microsoft Windows, Excel, Word and database application (data entry, not programming). Adaptive, cooperative With working experience using Blue Mountain Software or similar calibration database software Effective writing and communication skills Dependable, Responsible, can work without supervision EDUCATION AND EXPERIENCE High School Diploma and a minimum of 6 - 10 years' experience. Certification in Metrology/Calibration or equivalent work experience. Creates Measurement Data Templates, or Work Plan Templates in BMRAM (Calibration Database) where applicable. Assist in creating/updating calibration procedures as needed. Protects equipment from damage. Provide guidance to equipment owners/engineers when purchasing new equipment to help ensure suitability to the process or parameters being monitored and ability to calibrate equipment internally or local vendor's capability. Acts as the Local Admin of the Environmental Monitoring System (VAISALA). Monitors alarms, owner's acknowledgement and justifications provided for each alarm, follows-up with equipment owners when alarms are not acknowledged, troubleshoot system, train new users, grants access to the system, provide reports to stakeholders when requested. etc. Reduce calibrations performed by outside services by expanding in-house capabilities, where possible. May support as a back-up to Calibration Coordinator Supports cross-training initiatives Supports continuous improvement efforts. Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management. Support internal/external audits as needed. Follows BDIS Environmental, Health and Safety (EH&S) policies and procedures. Takes responsibility for safety in immediate work area. Participates in EH&S programs. Notifies supervisor of all observed hazardous conditions or unsafe work practices. May provide recommendations on maintaining the safety of the work environment. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. #earlycareer #LI-TR1 Required Skills Optional Skills . Primary Work LocationUSA CA - Milpitas 155Additional LocationsWork ShiftUS BD 1st Shift 8am-430pm (United States of America) At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $31.10 - $48.20

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role The senior supervisor plays a critical role in ensuring strict compliance with regulatory requirements and the site's quality management system, including consistent adherence to validated standard operating procedures. As a frontline leader, this role drives capacity, throughput, labor efficiency, and downtime reduction to maximize operational performance through Kaizen events and continuous improvement. In addition, the senior supervisor is responsible for building a stable workforce through effective recruiting, training and retention of staff - ultimately ensuring the reliable production of high quality lifesaving medical devices. Your team: Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. What You'll be Doing * Provide mentorship, support, direction, and leadership through positive interactions with all personnel during daily operations. * Supervise day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities to meet customer requirements, including deadlines and quality standards. * Interview, hire, mentor, motivate, develop, and guide staff. Conduct annual performance reviews for all direct reports, assist in setting performance objectives and development plans, and monitor progress. * Review, approve, and manage documentation for batch and system records. Assist in meeting product release time goals. * Highlight training programs aimed at enabling staff to consistently implement all manufacturing processes in strict adherence to cGMPs and EHS regulations. * Develop and implement performance measurement and internal auditing programs to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments. * Perform/lead technical reviews, investigations, and process improvement projects. * Offer insights from manufacturing to support the integration and validation of new equipment and processes. * Resolve technical, material, and cGMP problems that may impact project deadlines. Provide mentorship and troubleshooting assistance as needed during a deviation in the process. * Act as the company's representative during FDA inspections. Offer the required information to the FDA to establish credibility and showcase adherence to cGMPs. * Provide a positive and equitable working environment emphasizing the Baxter Shared Values: Respect /Responsiveness / Results. * Identify, initiate, and facilitate continuous improvements, lean manufacturing activities, and initiatives, such as 5S, visual management, kaizens. * Identify and implement Manufacturing savings projects. * Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs), and Current Good Manufacturing Practices (cGMP). * Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap, and others as needed. * Work weekends and daily overtime and work inside the cleanroom to monitor, mentor, and lead the team. What You'll Bring * Proven track record of interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment. * Profound understanding of relevant manufacturing machinery and procedures. * Ability to handle numerous tasks in a manufacturing plant setting. * Ability to analyze and interpret scientific and statistical data. * Proficient in professional writing and capable of drafting technical reports. * Ability to clearly articulate information during regulatory/client inspections. * Ability to understand GMPs and other applicable regulatory guidelines. * Strong assessment and troubleshooting skills. * Ability to respond to detailed inquiries and present information to groups and senior leaders. * Ability to supervise multiple groups/shifts, if applicable. * Strong computer skills in Microsoft Office and experience with enterprise software. * Bachelor's degree required. * 3-5 years of manufacturing experience. * 2+ years of supervisory experience. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more open with our pay practices. The estimated base salary for this position is $76,000 - $104,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonus. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time." US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Req ID: 4313 Company: Terumo Medical Corporation Department: TIS Sales - Pacific Northwest Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. **Join us and help shape wherever we go next!** **_Advancing healthcare with heart_** **Job Summary** _Serving as_ a subject matter expert (SME), provides directed product support education, training and insight in the proper use of specialty medical devices in selected diagnostic and interventional procedures. Possesses the ability to proctor physicians and/or ancillary staff in procedures where these devices are utilized, provide in services and presentations on technologies, medical devices and on specific procedures to customers. _Customers typically include physicians, nurses, and other medical and ancillary medical personnel._ _Under minimal direct supervision, provides highly specialized technical training typically in a clinical and/or surgical environment. Collaborates with internal teams on the research, development, implementation and maintaining of product training support, materials, programs and initiatives in the field setting and on a requested basis, in the home office and potential to our manufacturing facility._ **Job Details/Responsibilities** Train internal and external customers (Physicians, clinicians, and technicians) on the proper technique and use of therapeutic and diagnostic TIS products. Serve as a company liaison with customers on clinical and technical matters supporting company initiatives, projects and products. Communicate verbally and written with marketing and sales teams to address technical, and clinical issues. Operate computer simulation equipment and support the use of various vessel model units during trade shows, local clinical meetings and PACE sponsored courses to assist in the delivery of education and knowledge transfer related to specific products and procedure guidance. Develop and maintain clinical communications to support, document and drive appropriate product utilization. Work with sales and marketing, internal departments and customers to resolve clinical and technical related problems. Support clinical seminars and medical society sponsored symposia and courses. Visit key customers to evaluate products and help maintain good customer relationships, gain competitive knowledge and new product concepts or product enhancement ideas. Ensure clinical compatibility between all TIS products within the scope of procedural application. Work with marketing and sales to implement tactics supporting strategic goals and product related tactics and provide feedback through the established (PPR) Product Performance Reporting process. Ensure to the best of their ability TIS products are used appropriately regarding patient safety and intended use. Demonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems requirements. This includes but is not limited to the prompt recognition and forwarding of customer complaints (i.e. adverse events, product performance reports, etc.) to Quality Assurance (QA), and by ensuring all promotional messaging (i.e. branding strategies, product claims, etc.) and materials (i.e. literature) discussed or presented to customers are clinically accurate and adhere to AdvaMed guidelines and Terumos policy on Interactions with Healthcare Professionals. Maintain strong knowledge of and adherence to regulations regarding promotional material content and control. Follow procedures for good clinical practices and Design Control when participating in new product development and clinical activities. Fully adhere to all applicable FDA regulations, international guidelines and Terumos policies at all times. Perform other job-related duties as assigned. **Job Responsibilities (continued)** **Working Conditions/Physical Requirements** + This is a field-based position. Must be able to drive personal automobile on a daily basis to/from customer accounts and drive long distances as necessary. + This position requires approximately 70% overnight travel by car and/or by air. In addition, occasional weekend travel is required. + Daily entry into hospitals and other medical facilities is required. Many facilities have instituted vendor credentialing policies which require vendors to meet defined training, background check and proof of immunization requirements as a condition of entry. Terumo Associates entering these facilities are required to abide by these credentialing requirements. + Must be able to gain access to and work in the IR suite, cath lab and operating room. Entry into these areas requires an ability to wear appropriate gowning, stand for long periods of time, comply with hospital policy/protocol and be aware of potential biohazards such as blood borne pathogens. + This position requires working in areas where ionizing radiation is present. Knowledge of radiation exposure and protections is a requirement. **Knowledge, Skills and Abilities (KSA)** + Strong technical and clinical knowledge in human anatomy and physiology and medical procedural techniques (preferably endovascular and/or cardiac). + Ability to quickly gain a thorough knowledge of company products and their recommended use. + Ability to handle customer inquiries and to respond with company information, selected reference material and analyze product applications and misapplications to diagnose product issues relating to usage, manufacture and/or failure. + Strong interpersonal and analytical skills, training and the ability to stay abreast of the current technology, company products and generally accepted medical practices related to products and procedural area. + Must be able to handle several time constrained projects simultaneously, while educating and satisfying both internal and external customers. + Ability to present and effectively communicate complex clinical and technical data to others of a non-scientific orientation and with varying backgrounds and knowledge levels. + Ability to apply business understanding to clinical support and customer facing/sales force interactions. **Qualifications/ Background Experiences** + Technical or professional health services licensure from an accredited licensing entity (i.e.: RT, RCIS, RN) or a 4 year health sciences or science related Bachelors degree and a minimum of 3 years experience in a clinical setting (peripheral and/or cardiology related). + AMinimum of 3 years scrubbing experience within the Cath Lab or Interventional Radiology environment. Prior experience as a Field Clinical Specialist with a medical device company is preferred. It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. **Nearest Major Market:** San Francisco **Nearest Secondary Market:** Oakland

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role Are you ready to take on an ambitious role where your expertise will build the future of our manufacturing excellence? At Baxter Healthcare Corporation, we are dedicated to making a difference in the lives of millions of people worldwide. As our new Manager, OpEx, you will play a pivotal role in developing our Operational Excellence (OpEx) initiatives at our Hayward, CA facility. You will collaborate with a world-class team to implement proven strategies and ensure flawless execution of key projects! Your team: Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. What You'll Be Doing * Drive the deployment of the OpEx program at the site. * Collaborate closely with site management to support their continuous improvement journey. * Develop and implement a site-level OpEx deployment plan, encompassing the Baxter Operating System (BOS), Improvement Projects, Certification Programs, Best Practices Sharing, iCare, and other initiatives. * Assist leadership in establishing baseline and target metrics for key processes. * Work with site leadership to install organizational supports for Operational Excellence, including reviews, communications, and rewards. * Coach and mentor site Black Belt and Green Belt candidates to ensure the timely completion of their quality and/or cost-focused projects, leading to their certification. What You'll Bring * Bachelor's in Business Management, Engineering, or a related field. Preferably, they hold an MBA, MS, or a similar technical graduate degree. * Being a Certified Black Belt with a strong grasp of LEAN Manufacturing principles is crucial. * minimum of 5 years of experience in business operations and/or plant manufacturing or engineering, with at least 3 years of successful process improvement experience. * Proven experience in managing teams and developing support programs. * Six Sigma Black Belt certification is required; Master Black Belt is preferred. * Proficiency in LEAN tools and methodologies is essential. * Ability to function effectively in a team environment and directly lead or co-lead high-impact process improvement projects. * Demonstrated ability to manage multiple projects simultaneously. * Strong skills in working with cross-functional teams. * Excellent negotiating and influencing skills, with the ability to inspire change. * Outstanding reading, writing, and verbal communication skills in both the local language and English, coupled with strong teaching and presentation abilities. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 - $143,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role at Baxter The Manufacturing Technician IV is responsible for assisting the supervisor in organizing, scheduling and directing other team members as well as execute all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Manufacturing Technician IV may be the main interface with other functional departments to resolve issues. Represent the department in cross- functional team as necessary. Your team: Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. What You'll Be Doing * In-depth process knowledge of related manufacturing techniques and specialties. * Perform and lead local manufacturing operations. * Set up and operate general production equipment. * Perform complex equipment troubleshooting and respond to process alarms as necessary. * Support supervisor in reviewing relevant paperwork following GDP/GMP guidelines. * Initiation and lead Continuous Improvement Teams. * Receive and distribute supplies into the production area as necessary. * Create and revise pertinent documentation as appropriate. * Lead stretching exercises. * Prepare and package product for shipment, where applicable. * Train and mentor other team members and monitor training for newer team members. * Collaborate with all other functional groups to ensure preventative maintenance is scheduled and completed. * Print out and reconcile proper process documentation. * Complete and closed GME and Maximo work orders * Perform and lead cycle count and variance investigations. * May perform other duties as assigned. What You'll Bring * Requires High School diploma or GED equivalent with a minimum of 5-6 years of manufacturing related experience or * AA degree with 3-4 years of manufacturing related experience required or * Bachelor's degree with a minimum of 1 year of manufacturing related experience * Must be proficient in written and verbal communication skills and understanding of cGMP regulations. * Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement. * Must be able to read and follow detailed written instructions. * Good interpersonal skills and be able to work effectively and efficiently in a team environment. * This position requires shift, weekend and holiday work. Overtime may be required at times. * The incumbent must work in a clean room/classified environment wearing special garments. Additionally, personal protective equipment and hand sanitizer must be worn due to safety requirements. * Advanced knowledge of Microsoft Office/Word/Excel applications. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $60,000 - $82,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your role at Baxter: The Manufacturing Technician IV is responsible for assisting the supervisor in organizing, scheduling and directing other team members as well as execute all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Manufacturing Technician IV may be the main interface with other functional departments to resolve issues. Represent the department in cross- functional team as necessary. Your team: Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. What you'll be doing: * In-depth process knowledge of related manufacturing techniques and specialties. * Perform and lead local manufacturing operations. * Set up and operate general production equipment. * Perform complex equipment troubleshooting and respond to process alarms as necessary. * Support supervisor in reviewing relevant paperwork following GDP/GMP guidelines. * Receive and distribute supplies into the production area as necessary. * Train and mentor other team members and monitor training for newer team members. * Perform and lead cycle count and variance investigations. What You'll Bring * Requires High School diploma or GED equivalent with a minimum of 5-6 years of manufacturing related experience or * AA degree with 3-4 years of manufacturing related experience required or * Bachelor's degree with a minimum of 1 year of manufacturing related experience * Must be proficient in written and verbal communication skills and understanding of cGMP regulations. * Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement. * Must be able to read and follow detailed written instructions. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $60,000- $82,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. * US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role As a Sr. Calibration Technician, you will be the subject matter expert in metrology and calibration. You'll ensure all measuring and test equipment meets strict standards, manage calibration schedules, and implement programs that comply with facility, corporate, and FDA requirements. This role requires independence, technical expertise, and collaboration across departments. Your Team You'll join the Quality Systems team at our Hayward, CA facility, reporting to the Manager of Quality Systems. Our team is dedicated to maintaining the highest standards of accuracy and compliance in a fast-paced manufacturing environment. What You'll Be Doing Test and calibrate various measuring and indicating equipment for conformance to established standards. Evaluate calibration results and determine the acceptability of the calibration performed, as well as implement corrective action for out-of-tolerance conditions. Adjust/repair instruments to meet calibration standards. Communicate any out-of-tolerance conditions (OOT) and support investigations, corrective/preventative actions, and documentation relative to OOT conditions. Maintain and control all calibration standards to ensure preservation of standards. Research and purchase new standards to improve calibration services for the facility. Manage calibrations scheduling system for all equipment and devices (both internal and outside lab schedules). Coordinate calibration activities to ensure all calibration due dates are met. Coordinate equipment calibration with outside vendors, including performing incoming inspections and documentation reviews on these instruments. Contribute to the selection of new equipment and assess new and existing equipment to assign calibration requirements (including tolerances and frequency of calibration), and then create or revise specifications and procedures accordingly. What You'll Bring Prior calibration experience is required. Must have strong organizational, oral and written communication skills. Must have a strong understanding of electrical, pneumatic, temperature, electronic and mechanical measurement techniques and concepts in a high-paced manufacturing environment. Must have strong computer skills including MS Suite. Must work well with minimal supervision on routine calibrations and various projects as an individual or in a team environment. Experience: High School degree required, 3-5 years in calibration or a related field; ASQ certification or Associate's Degree preferred. Physical Requirements: Ability to lift up to 50 lbs occasionally and perform tasks requiring close visual acuity. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $68,000 - $93,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Be part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.Duties and Responsibilities:Develops, revises, and reviews product package inserts and user's manuals to ensure compliance/conformity with existing Corporate, Regulatory and Global (ISO, PAL, etc.) guidelines.Develops, revises and reviews product package labeling (carton labels, component labels, package inserts and users' manuals) to ensure compliance/conformity with existing Corporate, Regulatory and Global (ISO, PAL, CE, etc.) guidelines.Works with internal teams (R&D, Marketing, Quality, Medical, Regulatory, and Plant production teams) to obtain an in-depth understanding of the product and the documentation requirements.Writes and/or prepares technical software documentation.Studies and reviews manufacturers' data, drawings, parts lists, and prototypes to delineate technology, operating procedures, and specific logistics of operation.Collaborates the development or revision of product documentation/digital content to determine specifications for: type style, font size, clarity and conformity of wording, formatting, topic-based order, and printing deliverables.Works with Incoming Inspection, Operations, and Quality to resolve issues regarding technical documentation and to develop procedures geared toward minimizing and eliminating recalls related to technical information.Creates and maintains multiple information architecture outputs.Analyses existing and potential content, focusing on reuse and single-sourcing opportunities.Develops and reviews Bill of Materials, vendor specifications for technical documentation, and develops and maintains graphic standards for manuals and digital content.Participates in the product development process and sustaining activities. Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business unit and plant projects to meet established goals.Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements; participates as required in training on regulatory issues affecting own area of work; brings regulatory compliance questions/issues to the attention of management.Qualifications:Bachelor's degree in English or related field with a minimum of five years of experience in technical writing and a minimum of two years of experience managing digital content projects; or equivalent combination of related education and experience. Ability to lead and participate in group projects, act as a team leader, develop project timelines, communicate effectively, and implement projects. Ability to handle multiple projects with excellent follow-up skills. Detail-oriented and have the ability to work under deadline pressure; must be able to deal with unresolved situations, frequent changes, delays, or unexpected events. Ability to perform spreadsheet and database maintenance for reporting the status of projects to management. Strong interpersonal and oral communication skills. Demonstrated proficiency in technical writing and editing for print and digital content. Functional knowledge of Microsoft Office Suite (MS Word, MS Excel). Demonstrated proficiency in DTP software applications (Adobe InDesign, Adobe FrameMaker, Adobe Illustrator).Knowledge of digital content software applications such as MadCap Flare or RoboHelp is required. Able to travel domestically and internationally up to 10%.For many roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates.To learn more about BD visit *************************** Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Additional Information All your information will be kept confidential according to EEO guidelines.

Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. Job responsibilities:Develop and execute international regulatory strategy for the successful registration of in vitro diagnostic (IVD) devices in markets outside of US and EU. Negotiate and establish product submission priorities that are aligned with IVDR priorities and region/country needs.Understands and interprets EU and international in vitro diagnostic (IVD) device regulatory requirements.Generate, coordinate, and manage regulatory submission documents for new products, renewals, or changes to existing products; ensure compliance with global regulations and guidelines. Coordinate responses to regulatory agencies as part of the submission and approval process.Represent RA in cross-functional product development teams to provide guidance on global regulatory strategies.Support change management by evaluating design, manufacturing and process changes for regulatory impact globally.Review Analytical and Clinical protocols to assure collection of appropriate data for regulatory submissions. Review/ Approve labels, labeling, and promotional materials for compliance with applicable regulations and policies. Develop and maintain procedures and/or work instructions for product registrations.Provide regulatory support during internal and external audits.Submit and maintain laser registrations for all instruments (IVD and RUO) when needed.Manage, monitor and track International product registration in Regulatory Information Management (RIM) database to ensure up to date information.Additional activities as needed to support RA goals. Minimum Qualifications:Education and Experience:Bachelor's degree required, strongly preferred in the biological sciences, chemistry or related science.Minimum 3 years' experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs. Tech file preparation and approval experience a plus.Ideal candidate will have demonstrated ability to interpret new regulations, and understand and interpret in vitro diagnostic device (IVD) regulatory requirements.Current knowledge of in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); and European quality system standards. Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization. Strong Project Management experience desirable, ability to prioritize, multi task, and organize work.For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit ******************** Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Additional Information All your information will be kept confidential according to EEO guidelines.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role As a Sr. Calibration Technician, you will be the subject matter expert in metrology and calibration. You'll ensure all measuring and test equipment meets strict standards, manage calibration schedules, and implement programs that comply with facility, corporate, and FDA requirements. This role requires independence, technical expertise, and collaboration across departments. Your Team You'll join the Quality Systems team at our Hayward, CA facility, reporting to the Manager of Quality Systems. Our team is dedicated to maintaining the highest standards of accuracy and compliance in a fast-paced manufacturing environment. What You'll Be Doing * Test and calibrate various measuring and indicating equipment for conformance to established standards. * Evaluate calibration results and determine the acceptability of the calibration performed, as well as implement corrective action for out-of-tolerance conditions. * Adjust/repair instruments to meet calibration standards. * Communicate any out-of-tolerance conditions (OOT) and support investigations, corrective/preventative actions, and documentation relative to OOT conditions. * Maintain and control all calibration standards to ensure preservation of standards. Research and purchase new standards to improve calibration services for the facility. * Manage calibrations scheduling system for all equipment and devices (both internal and outside lab schedules). Coordinate calibration activities to ensure all calibration due dates are met. * Coordinate equipment calibration with outside vendors, including performing incoming inspections and documentation reviews on these instruments. * Contribute to the selection of new equipment and assess new and existing equipment to assign calibration requirements (including tolerances and frequency of calibration), and then create or revise specifications and procedures accordingly. What You'll Bring * Prior calibration experience is required. * Must have strong organizational, oral and written communication skills. * Must have a strong understanding of electrical, pneumatic, temperature, electronic and mechanical measurement techniques and concepts in a high-paced manufacturing environment. * Must have strong computer skills including MS Suite. * Must work well with minimal supervision on routine calibrations and various projects as an individual or in a team environment. * Experience: High School degree required, 3-5 years in calibration or a related field; ASQ certification or Associate's Degree preferred. * Physical Requirements: Ability to lift up to 50 lbs occasionally and perform tasks requiring close visual acuity. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $68,000 - $93,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Be part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.Primary Duties and Responsibilities: Conjugate various fluorochromes or organic compounds onto purified monoclonal antibodies and reagents by established procedures.Monitor conjugation processes at several stages. Select appropriate fractions to maximize yield and quality of product.Investigate and develop new methods and technologies for projects and process advancements as defined by senior chemist.Prepare technical reports, summaries, and quantitative analyses of assigned research projects.Tabulate and analyze data for all phases of a research project utilizing statistical software packages.Prepare protocols for simple experiments under supervision.Prepare and revises Standard Operating Procedures (SOP) and other documentation. Submit proposed revisions to senior chemist for review and approval.Maintain meticulous records of all results.Maintain assigned equipment and related logs and records.Purifies monoclonal antibodies from serum/ascites fluid and tissue culture supernatant by appropriate serum fractionation and /or column chromatographic techniques.Monitors purification processes at several stages to maximize yield and degree of purity of antibody.Keep abreast of the basic requirements for compliance in own area of work and comply with those requirements. Participate as required in training on regulatory issues affecting own area of work. Bring regulatory compliance questions/issues to the attention of management.Promote a safe work environment. May provide recommendations on maintaining the safety of work environment. Participate in Environmental Health and Safety programs. Address corrective actions whenever a hazard is identified. notifies managers of all observed hazardous conditions or unsafe work practices.Perform other related duties and assignments as required.Minimum Requirements:Bachelor's Degree5 Year's Lab experience For many roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit ******************** Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN Additional Information All your information will be kept confidential according to EEO guidelines.

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Job Description Your role at Baxter: Our Field Service Technician II's primary responsibility is to perform complex repair work on all customer and company - owned medical equipment. In addition to the repair work, the FSII is also responsible for performing the same responsibilities as a FST I related to product readiness for patient utilization on a wide range of rental and customer owned medical products. This position requires operating a fleet vehicle in a safe manner as well as direct customer contact. Additionally, will provide 24/7 delivery, removal, and service support for products in service centers and customer accounts in a timely and professional manner. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most! Your team: The field service team works within hospital and service setting environments to repair medical devices. Baxter offers dental, medical, and vision insurance, paid time off, parental leave, and more. What You'll Do: Performs electronic, hydraulic and pneumatic systems troubleshooting and repair of assigned products. Ability to troubleshoot devices and repair any malfunctioning components. Ability to use the appropriate tools in making required adjustments and repairs. Ability to provide on-call coverage, up to 24/7 basis including weekends and holidays, which may require customer account visits. Ability to load, unload, and remove medical products, weighing up to 1680 pounds. Generate service revenue and complete activities required under service contract. Safely operate box truck vehicle or company car ranging in size from a cargo van up to a 26,000 pound truck. What You'll Bring: Must be at least 21 years of age High school diploma or GED or equivalent experience Valid driver's license and driving record Basic mathematical skills - addition, subtraction, multiplication, and division We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range rate of $51,200 - $70,400.The actual salary may vary based upon several factors including, but not limited to, relevant skills/ experience, time in role, business line, and geographic/ office location. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.