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Lantheus jobs in Billerica, MA - 127 jobs

  • Principal Business Analyst, SAP Production Planning for Process Industries (PP-PI, EWM, TM)

    Lantheus Holdings, Inc. 4.7company rating

    Lantheus Holdings, Inc. job in Bedford, MA

    Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands. Summary of role We are seeking a Principal Business Analyst, SAP Production Planning for Process Industries (PP-PI, EWM, TM). This position is based in Massachusetts and requires a presence on-site (two/three) days per week, and open to applicants authorized to work for any employer within the United States. Lantheus operates and maintains a portfolio of manufacturing, supply chain and transportation systems. This role has lead configuration responsibilities for the platform. Detailed configuration scope includes the following: PP-PI * Master recipe/phase/operation setup; resource capacities; material quantity calculation; control recipes; PI Sheets/XSteps; process messages; batch classification/derivation; goods movements (GI/GR) and confirmations; variance/settlement. EWM * Warehouse structure (storage types/sections/bins), HU types, packaging specs; inbound/outbound processes; staging for process orders; wave/slotting; physical inventory/cycle counts; exception codes; RF framework. TM * Dangerous goods master and checks; freight unit building; planning and carrier selection; tendering; event management; charge/settlement; alignment with EWM shipping and external documentation for radioactive shipments This Principal Business Analyst is expected to perform high-quality project and support work for his/her stakeholders, continue to build the SAP capability at Lantheus and foster its continued growth within the Lantheus' organization. Key Responsibilities/Essential Functions Manufacturing - PP‑PI (Process Orders) * Own the PP‑PI design across process instructions (PI Sheets/XSteps), master recipes, phases, and resources; enable electronic batch records (EBR) with robust batch derivation/determination strategies. * Build standard work for yield/variance handling, co‑/by‑products, rework, and stability studies; integrate with QM for in‑process controls, sampling, and usage decisions. * Implement capacity planning/ATP integration and coordinate with MES/LIMS for confirmations and data collection; support serialization/traceability and regulatory reporting. Warehouse - EWM * Architect EWM for radio‑pharma operations: storage type/bin strategies, HU management, putaway/picking, staging, wave management, and physical inventory/cycle counting; design packaging specifications for shielded containers and temperature‑controlled handling. * Enable advanced inbound/outbound (IBD/OBD) flows, dock/yard management as needed, and exception handling; optimize replenishment and production staging (PP‑PI → EWM integration). * Define RF process flows and user profiles; govern slotting/rearrangement for short‑lived isotopes and controlled materials. Transportation - TM (Nice to have) * Configure TM for dangerous goods classification, compliant routing, freight units/orders, carrier selection/tendering, and cost calculation; integrate DG checks for IATA/ADR/DOT‑hazmat rules. * Align TM with EWM shipping and radioactive generator shipment requirements, including palletization, routing, and weight hand‑offs to external systems. Quality, Compliance & Validation * Design solutions aligned to cGMP, 21 CFR Part 11/Annex 11, GDP, and SOX controls; author configuration documentation and support validation (VP, IQ/OQ/PQ), change control, and audit readiness in GxP scope. Integration & Data * Lead integrations across SAP (QM, MM, SD, GTS, FSCM), boundary apps (MES/LIMS, PLM, labeling/serial devices), and logistics partners; ensure master data stewardship (materials, batches, resources, recipes, BP, DG data). * Partner with Finance on cost object flows (orders, cost centers, profit centers) and reporting alignment in S/4; collaborate on inventory/traceability and regulatory exports. Leadership & Delivery * Serve as solution owner across PP‑PI/EWM/TM; drive roadmaps, govern design standards, mentor analysts, and guide vendor/partner work. * Lead workshops, fit‑to‑standard, backlog grooming, and cutover/hypercare; maintain a culture of safety, quality, and continuous improvement. Requirements * 8+ years SAP experience with 5+ years in S/4HANA/ECC across PP‑PI, EWM, and knowledge of TM, including at least 2 full‑cycle S/4 implementations. * Deep configuration mastery (SPRO) in PP‑PI (recipes, phases, PI Sheets/XSteps, batch mgmt), EWM (storage types, HU, waves, slotting, packing specs, RF), and TM (DG settings, freight order management, tendering, charge mgmt). * Demonstrated delivery in regulated (GxP) manufacturing environments with validated systems and audit trails. * Hands‑on integration experience with QM, SD, MM, GTS; familiarity with MES/LIMS interfaces and electronic batch records; working knowledge of serialization and cold‑chain processes. * Strong cross‑functional leadership, stakeholder management, and vendor orchestration; excellent documentation and communication skills. Preferred Requirements * Experience in radiopharmaceuticals or life‑sciences manufacturing (isotope generators, sterile compounding, short‑half‑life products) and related dangerous goods compliance (IATA/ADR/DOT). * Knowledge of PP‑DS for capacity‑constrained scheduling, IBP demand/supply integration, and advanced ATP; exposure to private‑cloud S/4 operations and Fiori role‑based UX. * Prior work aligning job architecture and posting language with enterprise standards (Principal level). Core Values The ideal candidate will embody Lantheus core values: * Let people be their best * Respect one another and act as one * Learn, adapt, and win * Know someone's health is in our hands * Own the solution and make it happen The pay range for this position is between $111,000 and $185,000 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until January 22th, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at ******************************.
    $111k-185k yearly Easy Apply 5d ago
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  • Corporate Counsel

    Lantheus Holdings, Inc. 4.7company rating

    Lantheus Holdings, Inc. job in Bedford, MA

    About Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands. Summary of role Lantheus is seeking a motivated and intellectually curious attorney to join our Legal team to play a key role across many areas of legal work, collaborating with experienced attorneys to deliver practical, risk-oriented advice and services to the business with a focus on innovation, including strategic transactions, research collaborations, licensing, clinical development and alliances. This is a fantastic opportunity for someone who desires to advance their career and deepen their knowledge and expertise through broad exposure to a diverse array of critical legal work required to move our radiopharmaceutical company forward. This is an exciting opportunity to join the highly collaborative, experienced legal team of an established and growing Nasdaq-listed radiopharmaceutical company. The successful candidate will find the work with the Lantheus Legal Team to be sophisticated, diverse and challenging. We are committed to ensuring this position includes an opportunity for continued development and exposure to legal and business subject areas relevant to the Company. To start, we are looking for an admitted attorney with experience drafting, reviewing and negotiating different types of contracts who wants to play an instrumental role in supporting the Company's long-term growth strategy and core mission to find, fight and follow disease. This position is based in Massachusetts and requires a presence on-site three days per week, and open to applicants authorized to work for any employer within the United States. Responsibilities This individual will take on a key substantive legal role across the organization, working along with all members of our legal team and utilizing creative problem-solving skills and business judgment to ensure efficient and fit-for-purpose advice that is aligned to the Company's strategic priorities. This is a generalist role that will have the opportunity to learn and engage throughout a radiopharmaceutical product's lifecycle through contracting, including through strategic evidence generation, transactions, and other matters. A large portion of the work will center around contracting and related advice and projects. The successful candidate will be responsible for independently and efficiently drafting, reviewing and negotiating contract terms and conditions, including master service agreements and associated statements of work, consulting agreements, vendor / service provider agreements, confidentiality agreements, quality agreements, data processing agreements, data safety exchange agreements, clinical trial agreements, manufacturing and supply agreements, research agreements, licensing and collaboration agreements and other agreements as requested. Compliance with data protection and privacy laws will also be a focus area for this position. This is intended to be a development focused role with key responsibilities anticipated to be: * Supporting senior attorneys in drafting, reviewing, and negotiating agreements related to research collaborations, licensing, strategic alliances, development of investigational assets, and other innovation-driven transactions. * Assisting in legal due diligence, risk assessments, and deal structuring for corporate development initiatives and other strategic initiatives. * Collaborating with cross-functional teams including R&D, Clinical Development, Corporate Development, Pharma Solutions, Innovations and IP to align legal support with business objectives. * Helping to maintain and improve templates, playbooks, and knowledge management tools for innovation-related contracting. * Monitoring legal and regulatory developments relevant to strategic transactions and innovation partnerships. * Participating in internal meetings and contributing to the development of legal strategies that support long-term growth. * Supporting training and enablement efforts for business teams engaging in contract execution. * Potential International Association of Privacy Professionals Privacy certification program participation. This development role will work collaboratively across all functions of the Legal Department, gaining exposure to a broad range of legal matters. The individual will progressively assume responsibility for handling matters independently as they build knowledge and experience through hands-on learning and cross-functional engagement. Lantheus is also looking for the right fit for its legal team and the Company, which means the successful candidate must also have: * A passion for performing meaningful work that impacts patients' lives. * Strong technical drafting, analysis and negotiation skills, informed by a deep understanding of the business and its immediate and long-term objectives and guided by appropriate risk balancing. * A keen attention to detail, strong analytical reasoning, excellent communication skills, and the ability to manage diverse projects simultaneously and function independently. * Ability to incorporate artificial intelligence into day-to-day operations as part of continuous improvement initiatives. * The ability to collaborate and communicate with a diverse group of internal stakeholders and to represent the Company externally in negotiations with vendors, service providers and customers. * A compliance mindset, including the ability to ensure that contractual terms and provisions comply with the Company's Contract Policy, Grant of Authority, other guidelines and applicable law. * Integrity, sound judgment and respect for the confidential nature of the work we perform. * A willingness to develop subject matter expertise, both within the contracting space and in other areas outside of contracting, including data protection and privacy, as well as other laws and regulations that are relevant to a radiopharmaceutical company, by working on matters with colleagues on the Legal Team and adopting a learning and continuous improvement mindset. * A willingness to be a strong team player. The successful candidate must be able to: * Identify, assess and escalate risk and provide guidance to management and business stakeholders to support the decision-making process by business teams and / or other members of the Legal Team. * Adopt a continuous improvement mindset, revising and improving the contracting process and knowledge management efforts, such as templates, provision libraries and contracting playbooks to ensure deliberate, fit-for-purpose, tailored contract provisions. * Partner with business leaders to manage counterparties, advise on rights and obligations, and resolve disputes appropriately, keeping the long-term relationship in mind. * Work with Legal colleagues to support the training of business partners on contract policies and processes, templates and fallback language to enable trained users throughout the business to adopt best practices and execute successfully using "self-service" contracting tools through the establishment of "contract champions" outside of the Legal Team. * Multi-task across a high-volume of projects, prioritize and manage timelines effectively in a responsive and professional manner and actively seek help from colleagues when appropriate. Basic Qualifications * J.D. degree with an impressive academic and professional background. * Five to ten years of broad experience at a law firm with relevance to the biotechnology or pharmaceutical industry being a plus. * Extensive contracting experience, and familiarity with pharmaceutical compliance, securities law, antitrust law and privacy laws a plus. * A member in good standing of at least one state bar with the ability to become a member of the Massachusetts bar. * Strong command of Microsoft Office suite of programs, including Excel, PowerPoint, Word, OneNote and Teams, as well as experience using email and calendar software (Outlook). * Expectation to be in the Bedford, MA office at least Tuesday, Wednesday and Thursday every week, but flexibility to be on-site on Mondays and Fridays is essential. Core Values The ideal candidate will embody Lantheus core values: * Let people be their best * Respect one another and act as one * Learn, adapt, and win * Know someone's health is in our hands * Own the solution and make it happen The pay range for this position is between $172,000 and $287,000 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until January 10, 2025. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at ******************************.
    $172k-287k yearly Easy Apply 28d ago
  • Technical Support Specialist

    Hologic 4.4company rating

    Marlborough, MA job

    United States All around the world people are looking for an answer, a test result, or a procedure that will offer them clarity and a path to a healthier life. By working with Diagnostic products that make a difference globally, your impact can be greater than you have ever imagined. Hologic offers a space for employees to own their passion and feel a sense of purpose each and every day. Our award-winning **Technical Support** team plays a big role in that mission. They provide phone and email support to both internal and external customers, troubleshooting issues with Hologic's cytology and molecular products. **Think this role is for you?** This individual has an ability for troubleshooting issues beyond "computer stuff." In this role, you will be troubleshooting our diagnostics instruments (cytology and molecular), reagents, and operator issues. You will be offering technical support to internal customers (R&D, Field Service, Quality, Marketing, etc.) and external customers (Lab technicians, hospitals, etc.) via phone and email. We provide support 24/7, you may be on-call and serve as back-up for technical and application support as needed, including some holidays. **Key Outcomes:** + Provide customers with service and product troubleshooting for cytology and molecular products, including instruments, reagents, and software, via phone and email. + Document calls in the CRM system and escalate issues that require further investigation. + Authorize return of customer product for investigation. + Determine replacement of product as warranted. **Potential Growth Opportunities:** + Represent Technical Support as specialist for designated product(s). + Act as liaison to other departments within the division concerning issues related to specific product lines. + Serve on product development or support teams. Provide Technical Support team with troubleshooting training and informational updates. + Work with Marketing and Service departments at the launch of new products. Reviewing or creating label copy, participate in pre- and post-launch teams. + Build relationships with partners and distributors. + Writing and reviewing procedures. + Provide guidance and coaching to other Technical Support personnel. **Do you have what it takes?** + You are technically inclined, you understand science - DNA, RNA, Cytology, reading the package insert on a medical product doesn't sound like a foreign language to you. + You have a customer service mentality, you are patient, have good communication and computer skills and are great at multi-tasking. + You are comfortable speaking on the phone and have flexibility in your schedule. + We are looking for someone who is eager to start their career in this field and wants to grow within the department. **Additional qualifications:** + Bachelor's degree in biology, Cytotechnology, Medical Laboratory Science, or related field (required). + ASCP Cytotechnologist (CT), Medical Technologist (MT) or Clinical Laboratory Scientist (CLS) certification or equivalent (desired). + Experience as a Cytology Prep Technician (desired). + Experience with cytology, RT PCR, molecular, or virology (desired). + Ability to troubleshoot Laboratory Information Systems interfaces and/or network computers (desired). If you are not sure that you are 100% qualified, but are up for the challenge, we want you to apply! The annualized base salary range for this role is $71,000 - $106,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
    $71k-106k yearly 37d ago
  • Intern, Graphic/Instructional Designer

    Hologic 4.4company rating

    Marlborough, MA job

    Marlborough, MA, United States **Help Us Shape the Future of Learning: Join Our Global Services Learning & Development Team!** Are you curious about how big companies train their teams to stay sharp and succeed? Our Global Services Learning & Development team is on a mission to empower over 500 Field Service Engineers (and more!) with the tools and knowledge they need to thrive. As a Summer Intern, you'll dive into the world of corporate training, working with experts to create and improve engaging learning experiences. If you're ready to grow your skills and make an impact, keep reading! **What you'll be up to during your 10-12 week adventure:** + Team up with our Instructional Designer to help create online courses and classroom training materials. + Keep our learning management system up-to-date by maintaining records and curricula. + Review and refresh training content so it's accurate, relevant, and (dare we say) interesting. + Collect feedback from learners and instructors to help us make our programs even better. + Join team meetings, share your ideas, and help us find smarter ways to do things. **Who we're hoping to meet:** + You can work full-time during the summer (May/June - August/September). + You're currently working on your Bachelor's or Master's degree, with at least one semester left after the internship. + Your major is in Graphic Design, Communications, Instructional Design, Education, or something similar. + You're heading into your junior or senior year, or you're a master's degree candidate. + You know how to get your point across, whether you're writing or speaking. + You've got some experience with MS Office (Excel, Word, PowerPoint)-bonus points if you've dabbled with LMS platforms, e-learning tools, or design/video editing tools. + You notice the little things and keep yourself organized (your planner is probably color-coded). + You can roll solo or work as part of a team-flexibility is your middle name! **Location, pay & other important details:** + You can work **onsite** at our **Marlborough, MA** campus. **Heads up** : intern housing, relocation, and housing stipends aren't provided, so you'll need to have your living situation and transportation sorted out. + Pay range: $21 - $25 per hour, based on your class standing and operational function. + The chance to work with a team that's genuinely invested in your growth. + Networking, mentorship, and skill-building opportunities-all designed to help you thrive. **Take your internship to the next level at Hologic!** When you join Hologic as a Summer Intern, you're not just clocking in for a job-you're jumping into a global team full of motivated, creative, and dedicated people (basically, your future favorite coworkers). This is your chance to shine, show off what you know, and bring your energy and ideas to projects that make a real difference for people all over the world. On top of hands-on experience in your field, our College Relations team will hook you up with opportunities to learn about the company, meet leaders, and build the skills you'll need to launch your career. Consider this your backstage pass to the future of healthcare innovation. **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** \#LI-EK1
    $21-25 hourly 38d ago
  • Medical Science Liaison, Radiology

    Hologic 4.4company rating

    Marlborough, MA job

    United States At Hologic, we're an innovative medical technology organization that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we've been able to expand our offerings to empower even more people and champion women's health What powers our growth across Breast & Skeletal Health, Diagnostics and GYN Surgical Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access. None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities. While we focus on women's health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind. Hologic Breast & Skeletal Health team is seeking a field based Medical Science Liaison (MSL) to join the team. **Duties & Responsibilities:** + Facilitate the exchange of medical and scientific data to a targeted audience including key opinion leaders (KOL's), physicians, and other health care providers regarding Breast and Skeletal Health products via in-person or virtual presentations to increase awareness of technology. + Develop content to support peer-to-peer scientific discussions regarding clinical evidence. + Support cross functional teams in initiatives such as faculty speaker training and review of promotional and educational scientific materials. + Conduct medical and scientific education and support for the field organization. + Maintains clinical, scientific, and technical expertise via review of scientific journals, partnership with product and technology experts, and attendance at conferences, technical meetings and symposia. **Qualifications:** + Ability to rapidly acquire knowledge of applicable disease states, clinical trends, and emerging research related to Hologic's Breast and Skeletal Health products and knowledge of the competitive landscape in the breast cancer screening, diagnosis, and treatment space. + Ability to work successfully in a team environment, and engage regularly with marketing, clinical affairs, regulatory affairs, legal, sales management, and R&D to understand scientific/clinical information, business strategies, and market dynamics in order to execute the appropriate clinical discussions with customers. + Ability to communicate complex messages clearly. + Excellent verbal and written communication skills, with experience writing and publishing materials for peer reviewed publications preferred. + Advanced scientific analytical skills. + Ability to integrate and apply feedback in a professional manner. **Education/ Experience:** + Ph.D. in an applicable scientific discipline, with post-doctoral fellowship training in a biomedical science discipline desired but not required. + One to three years clinical, medical or scientific experience within a medical device, biotechnology or pharmaceutical company desired. + Oncology, radiology or medical imaging experience, particularly in breast cancer, is preferred. **Additional Details:** + Work is performed in a home office, company office, conference environments and customer sites + Position requires ~25-50% travel; may include overnight and weekend travel The annualized base salary range for this role is $128,700 to $201,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. **Agency and Third Party Recruiter Notice** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. **Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.** **\#LI-JM1**
    $128.7k-201.4k yearly 48d ago
  • Facility Mechanic

    Hologic 4.4company rating

    Marlborough, MA job

    The Facility Mechanic will execute facility maintenance service activities to support Hologic's mission and business objectives. This position works as part of our facilities team, providing a broad range of hands-on responsibilities. The ideal candidate demonstrates excellent customer service, the ability to work independently, and a strong work ethic. Key Responsibilities: Perform general repair and maintenance duties, including drywall repair, painting, systems furniture modifications, lamp replacement, small plumbing repairs, and other facility-related tasks. Provide hands-on support for internal and external facility moves. Organize and manage inventory of facility furniture. Provide routine on-call assistance as required. Deliver building maintenance services through preventive maintenance (PM) and work order (WO) programs, maintaining accurate records. Coordinate and support contracted facility services (housekeeping, pest control, HVAC, electrical, etc.). Provide maintenance support across multiple facilities as needed. Assist with workstation reconfiguration requirements. Coordinate and support building maintenance activities with landlord or affiliated contractors (generator, HVAC, compressor, etc.). Organize, inventory, and reorder facility-related safety and maintenance supplies as needed. Comply with all company policies and procedures, including safety regulations, PPE requirements, SOPs, Quality System Regulations, and Good Manufacturing Practices (GMP). Support Environmental, Health, and Safety (EHS) initiatives, including weekly and monthly maintenance tasks. Participate in insurance-required human element procedures, such as fire alarm shutdowns, hot work permits, and sprinkler valve checklists. Qualifications: Strong communication, interpersonal, and organizational skills. Excellent customer service skills for both internal and external customers. Proficiency with Microsoft Office. Ability to prioritize and manage multiple tasks effectively. Basic understanding of facility operations. Ability to work independently and complete assignments with minimal supervision. Ability to occasionally lift up to 70 lbs. Familiarity with FDA-regulated environments. Possess a valid driver's license and reliable transportation. Ability to travel occasionally (less than 5% of the time) to other Hologic office locations, as needed. Education & Experience: High school diploma required. Minimum of 2+ years of maintenance experience, preferably in a regulated environment. Training Requirements: All employees are required to complete training in relevant policies and procedures based on facility activities and corporate standards. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you! The annualized base salary range for this role is $44,500 - $66,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
    $44.5k-66.8k yearly Auto-Apply 27d ago
  • Vice President of Surgical R&D

    Hologic 4.4company rating

    Marlborough, MA job

    Denver, CO, United States The Vice President, Research & Development, GYN Surgical will be reporting to the Division President. The successful candidate will be accountable to engage a global team and build/execute on the future product development strategy of the division. As a member of the GSS leadership team, the leader will contribute his or her understanding of the business and customers to facilitate the acceleration of the Surgical commercial performance and results with both disposable, reusable and capital devices. The VP, R&D will play a role in defining the business strategy and will be responsible for early-stage research, new product development, and sustainment projects. The VP, R&D will play a key role over the entire product lifecycle, including understanding of existing product performance, reliability, complaints and customer experience, and maintaining a high-quality product portfolio. As Hologic is active on the mergers and acquisitions front, the leader will need to steer key deliverables as it relates to due diligence and integration activities. **Key Leadership Responsibilities** + Lead the teams of Mechanical, Software, Electrical, Systems and PMO, which operate in key strategic areas like GYN Surgical and Specialty Surgery (ie energy) and promote a high-performance and results-driven culture. + Attract, develop and retain top talent for the R&D function, while motivating staff to continually improve its performance. + Execute on the division's overall vision, shaping its technical strategy, leading all engineering efforts and driving its development execution + Partner with Marketing in developing a strong product pipeline and a portfolio of marketed products that are differentiated and provide competitive advantage for Hologic. + Formulate and implement the long-term strategy with respect to new, emerging, and disruptive technologies that advance company objectives. + Collaborate closely with all functional areas necessary to aggressively advance products from proof of concept through validation and product launch, including Regulatory, Quality, Manufacturing, Finance, Legal, Business Development, Sales & Marketing + Work closely with management to effectively identify new intellectual property (IP) initiatives and translate those into new products and/or procedures + Monitor and analyze technology and trends that could improve the company's products and performance + Lead technical support team, monitor existing product portfolio, collect complaints, and support initiative to improve customer experience. + Serve as a member of the leadership team and key advisor to Division President in defining and directing the strategy, key priorities and decisions for business. + Directly responsible for the establishing and managing the R&D/Engineering budget More specifically, the **minimum requirements** set for this role are: + Bachelors in Engineering, Mechanical/Electrical or equivalent required + PhD in related field strongly preferred + 15+ years of global experience in Engineering, Development, or Strategy roles + 10+ years of managerial experience, managing people and budgets (P&L's), collaborating and influencing executive level leaders within sales, marketing and other commercial functions + Demonstrated success working in an innovative environment and in the development of products and services + Experience in setting and scaling the research and development function, with the proven ability to attract, inspire, motivate and retain top tier talent. **So why join Hologic?** We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary as well as quarterly commission based on sales target. **Agency and Third Party Recruiter Notice:** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic's employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
    $138k-192k yearly est. 60d+ ago
  • Senior Product Quality Engineer

    Hologic 4.4company rating

    Marlborough, MA job

    Marlborough, MA, United States Are you passionate about ensuring the quality and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In this role, you'll lead investigations into post-market feedback and complaints, conduct root cause analyses, and implement corrective or preventive actions to ensure our products meet the highest standards of quality and safety. Collaborating with cross-functional teams, you'll drive product and process improvements while making a meaningful impact on the lives of patients worldwide. If you're a proactive problem-solver with experience in quality, risk management, and engineering, we'd love to have you on our team! **Knowledge:** + Strong understanding of FDA Quality System Regulations, particularly Design Control requirements. + In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). + Familiarity with test method validation, root cause failure analysis, and statistical methods. + Knowledge of system-level requirements for complex medical devices, including software, electromechanical, and hardware components. + Awareness of reliability, electrical safety, sterilization, packaging, and biocompatibility standards. **Skills:** + Proven ability to lead cross-functional teams in conducting investigations and implementing corrective and preventive actions (CAPAs). + Strong analytical skills to prioritize complaints and investigations based on risk, data analysis, and strategic impact. + Excellent project management skills, including implementing design or process changes, performing testing, and managing change control documentation. + Ability to perform independent health risk assessments and present findings to leadership. + Effective communication skills to present product quality metrics, root cause analyses, and recommended actions to internal stakeholders and leadership. + Strong ability to assess and review written product and project documentation for compliance. + Preferred: Experience with verification and validation requirements, design of experiments, and requirements analysis for regulated products. **Behaviors:** + Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance. + Proactive and decisive, with the ability to independently prioritize tasks and resolve conflicts. + Collaborative and team-oriented, with a focus on fostering productive working relationships across functions. + Problem-solving mindset, focused on identifying root causes and driving effective solutions. + Customer-focused, with a commitment to addressing product quality issues and ensuring customer satisfaction. + Driven by continuous improvement, with a desire to optimize processes and enhance product quality. **Experience:** + **5+ years** of experience in engineering, preferably in a regulated industry such as medical devices. + Hands-on experience with root cause analysis, product development, or R&D. + Beneficial experience includes supporting complex medical devices (e.g., software, electromechanical systems) at the system level. **Education:** + Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field). **Why join Hologic?** We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. **Agency and Third-Party Recruiter Notice** _Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered._ **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** \#LI-NT1
    $97.6k-152.7k yearly 60d+ ago
  • Quality Assurance Engineer 2

    Hologic 4.4company rating

    Marlborough, MA job

    Are you passionate about ensuring the safety and reliability of life-saving medical devices? At Hologic, we are seeking a Quality Assurance Engineer - Product Quality to play a critical role in managing product holds, stop ships, corrections, and field actions. In this role, you'll develop and maintain Quality Management System (QMS) procedures, collaborate with cross-functional teams, and drive process improvements to ensure compliance and efficiency. If you're detail-oriented, proactive, and eager to contribute to the continuous improvement of product quality, this is your opportunity to make a meaningful impact in the healthcare industry. Knowledge: Strong understanding of Quality Management Systems (QMS) and regulatory requirements, including field action management, product holds, and stop ships. Familiarity with FDA regulations, ISO 13485 standards, and corrective/removal action processes. Knowledge of product lifecycle management systems and best practices for tracking quality records. Expertise in root cause analysis methodologies and corrective action processes. Skills: Proven ability to develop, implement, and maintain QMS procedures and work instructions for product holds, stop ships, and corrections/removals. Strong organizational skills to plan, execute, and monitor field actions, recalls, and corrective actions. Effective communication skills to liaise with corporate process owners, external vendors, and cross-functional teams. Technical writing skills for documenting progress, tracking closure of records, and creating training materials. Ability to conduct complex investigations and provide clarity into root cause findings. Proficiency in identifying process improvements and recommending enhancements to quality systems. Experience in providing training, guidance, and ongoing support to ensure proper utilization of quality tools and systems. Behaviors: Proactive and detail-oriented, ensuring timely execution of quality processes and compliance with regulatory requirements. Collaborative and team-oriented, building strong partnerships across functions to drive results. Problem-solving mindset, with a focus on continuous improvement and operational efficiency. Results-driven, with the ability to manage escalations and adverse trends effectively. Adaptable and resilient, thriving in a fast-paced, regulated environment. Experience: 2-4 years in Quality Assurance, Project Management or Customer Service roles in a medical device or related regulated industry. Hands-on experience with field actions, product holds, stop ship processes, and corrective/removal activities. Proven track record of supporting QMS initiatives, including integration and process improvements. Experience conducting complex investigations and implementing corrective actions. Familiarity with cross-functional collaboration on quality improvement projects. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $78,000-$122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1
    $78k-122.1k yearly Auto-Apply 21d ago
  • Intern, Upstream Marketing - Skeletal Health

    Hologic 4.4company rating

    Marlborough, MA job

    Marlborough, MA, United States **Dive Into Market Insights: Summer Intern, Upstream Marketing - Skeletal Health** Curious about how companies figure out what customers want and where to grow next? Join our Upstream Marketing team for the summer and get a behind-the-scenes look at how Hologic's Skeletal Health business shapes its strategy. You'll work on real projects that help us understand the market, identify new growth opportunities, and make smart moves in the bone and human performance space. This is your chance to turn classroom theory into impact (and maybe flex those Excel muscles, too). **What you'll be up to during your 10-12 week adventure:** + Dig into market research to spot and define key customer groups in the US for our skeletal health business. + Analyze customer behavior and purchasing trends-think of it as detective work, but with spreadsheets instead of a magnifying glass. + Create clear, easy-to-understand summaries about each segment, highlighting who they are and what they care about. + Pinpoint the biggest growth opportunities for our business (no pressure, but we're counting on your sharp insights!). + Suggest strategies and product ideas to help us reach more customers and make a bigger impact. **Who we're hoping to meet:** + You can work full-time during the summer (May/June - August/September). + You're currently working on your Bachelor's degree, with at least one semester left after the internship. + Your major is in Business, Marketing, Economics, or something similar. + You're heading into your junior or senior year preferably. + You know how to get your point across, whether you're writing or speaking. + You're comfortable with Microsoft Excel and PowerPoint-pivot tables and slides don't scare you. + You're naturally curious, organized, and ready to dive into data. + You can work independently, but you know when to ask for help. **Location, pay & other important details:** + You can work **onsite** at our **Marlborough, MA** campus. **Heads up:** intern housing, relocation, and housing stipends aren't provided, so you'll need to have your living situation and transportation sorted out. + Pay range: $22 - $28 per hour, based on your class standing and operational function. + The chance to work with a team that's genuinely invested in your growth. + Networking, mentorship, and skill-building opportunities-all designed to help you thrive. **Take your internship to the next level at Hologic!** When you join Hologic as a Summer Intern, you're not just clocking in for a job-you're jumping into a global team full of motivated, creative, and dedicated people (basically, your future favorite coworkers). This is your chance to shine, show off what you know, and bring your energy and ideas to projects that make a real difference for people all over the world. On top of hands-on experience in your field, our College Relations team will hook you up with opportunities to learn about the company, meet leaders, and build the skills you'll need to launch your career. Consider this your backstage pass to the future of healthcare innovation. **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** \#LI-EK1
    $22-28 hourly 31d ago
  • Sr Director, Global Supply Chain, IT Solutions

    Hologic 4.4company rating

    Boston, MA job

    Join Hologic's Global IT Function as a Supply Chain Technology Leader Step into a pivotal leadership role within Hologic's Global IT team, where you'll act as a trusted business partner to our global supply chain and operations stakeholders. You will help shape and execute our global strategy and roadmap for supply chain operations, serving as a thought partner to senior executives and enabling our teams to achieve success and positively impact lives every day. Reporting to the VP of Corporate IT Solutions, this leadership role is responsible for developing and deploying a comprehensive IT solution roadmap to optimize enterprise solutions for Global Supply Chain (GSC) operations. These solutions encompass Global IT strategies for Plan to Make, Sourcing, and Order to Deliver processes, supporting company growth. The Sr. Director of IT will own senior executive business partnerships, relationships, and the success of business system solutions. Additionally, this role provides direct oversight to the Global GSC IT team, delivering innovative system solutions across global business process areas. As the IT partner for Global Supply Chain the ideal candidate is a self-motivated, driven individual with proven strategic IT and operational experience. Experience demonstrates excellence in team leadership. management and results orientation, along with the following qualifications below. This is an onsite role based in Marlborough, MA. What we are looking for: * Over 10 years of leadership experience driving IT solutions on a global scale, ideally within regulated environments including leading large-scale ERP and industry-leading enterprise technology solutions. * Deep, proven expertise in solution process areas related to Global Supply Chain Operations, with additional expertise in Finance, Accounting, Human Resources, Quality, and Regulatory Operations is highly desirable. * Demonstrated expertise in Oracle ERP; knowledge of Oracle Cloud is preferred. * Proven ability to drive innovative technology solutions on a global scale. * BS/BA in Business Administration, Computer Science, or Supply Chain; MBA preferred. 10-15 years of related consulting and/or business operations leadership experience preferred. * Strong fundamental knowledge of planning, scheduling, manufacturing, sourcing, order management, and logistics business processes on a global scale. Required Skills we would like you to bring: * Excellent communication and presentation abilities. * Holistic understanding of systems, including business process management, requirements gathering, testing, data conversion, change management, and cutover strategies. * Ability to translate broad corporate strategies into clear, actionable business deliverables and solutions. * Skill in synthesizing industry trends and disruptive technologies to define business impact using data and evidence. * Excellence in talent management, building, and developing teams to meet current and future business needs. * Strong collaboration and partnership skills with business and IT partners to drive technology roadmap development and change initiatives. * Proven leadership experience in complex, matrixed global organizations. * Effective preparation and delivery of IT quarterly business reviews to senior Supply Chain and Regulatory leadership. * Collaboration with internal IT leaders to ensure compliance, governance, and alignment of project roadmaps with key business priorities and resources. Behaviors we are seeking for this position: * Demonstrated talent development and ability to inspire high-performing, diverse teams. * Strong partnership skills to collaborate and ensure optimal IT solution selection. * Excellent verbal and written communication skills, suitable for all organizational levels. * Strong relationship management skills, with the ability to influence, set expectations, deliver results, and drive outcomes. * Ability to build trust and be actively sought out for knowledge and opinions by extended IT and business teams. The annualized base salary range for this role is $185,600 to $330,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand. Why Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. If you have the right skills and experience, apply today! #LI-RF1 #LI-SeniorDirector Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
    $185.6k-330.1k yearly 60d+ ago
  • Sr. Electrical Engineer - Product Engineering - Marlborough, MA

    Hologic 4.4company rating

    Marlborough, MA job

    Marlborough, MA, United States As a **Sr. Electrical Engineer, Product Engineering** , you'll maintain hardware continuity for our existing portfolio and drive design improvements that elevate quality, performance, and cost efficiency. You'll be a key stakeholder across Regulatory, Quality, Manufacturing, and external suppliers-leading and supporting multiple projects simultaneously. Your expertise will help troubleshoot hardware issues, develop robust verification strategies for design changes, and support the continuous improvement of our systems. This role will be located in Marlborough, MA and we will require 100% onsite presence. **Key Responsibilities:** + Safeguard the lifecycle of existing products by evaluating and managing electrical component End-of-Life (EOL) across multiple PCBs and products. + Lead troubleshooting efforts for electrical and electro-mechanical systems on field returns, determining root causes and implementing design changes based on quality and risk imperatives. + Drive hardware design efforts for product line extensions, VIPs (Value Improving Projects), and new features for existing products. + Develop electrical test fixtures and prototype boards to support testing and design improvements. + Support manufacturing with process and fixture improvements for critical hardware. + Collaborate with strategic sourcing partners and suppliers to implement technical cost-saving design changes and solve design challenges. + Interpret and improve verification methods for electrical components, PCBs, and subsystems to ensure state-of-the-art practices. + Build and maintain strong collaborative relationships with key internal and external stakeholders. + Stay current with emerging technologies and processes to fuel ongoing innovation across the portfolio. **Qualifications & Experience:** + Bachelor's or Master's in Electrical Engineering. + 5+ years' experience in new product development and/or medical device industry (with Bachelor's). + 3+ years' experience in new product development and/or medical device industry (with Master's). **Skills & Attributes:** + Ability to troubleshoot and root cause failure modes in PCBs and electro-mechanical systems. + Schematic-level design experience, preferably with Altium toolset. + Proficiency with electrical test and development equipment (oscilloscopes, LCR meters, logic analyzers, power supplies). + Foundational knowledge of DFM (Design for Manufacturing) in electrical engineering design. + Experience with FPGAs, CPLDs, analog and digital circuits, microcontrollers, and power delivery circuitry. + Experience designing for IEC 60601 safety and EMC compliance. + Familiarity with embedded systems and ability to collaborate with hardware and software teams. + Exceptional verbal, written, and presentation communication skills, with the ability to adapt for technical and non-technical audiences. + Proficient in generating technical documentation, including test protocols, reports, and design descriptions. **Travel:** Ability to travel as necessary, up to 10%. **So why join Hologic?** We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!The annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. LI-#DS1 \#onsite
    $97.6k-152.7k yearly 52d ago
  • Director, Design Assurance

    Hologic 4.4company rating

    Marlborough, MA job

    Newark, DE, United States Louisville, CO, United States Marlborough, MA, United States Are you a visionary leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a dynamic **Director of Design Assurance** to spearhead our Design Assurance organization, supporting new product development and sustaining activities for our Breast and Skeletal Health (BSH) products. This role is crucial in driving sustainable compliance, optimizing QMS processes, and fostering a culture of continuous improvement. We are located in Newark, DE and are open to hybrid presence. **What You'll Do:** + **Strategic Leadership** : + Direct the Design Assurance organization to support new product development and sustain activities for BSH products. + Ensure the appropriate organizational structure and personnel development to meet divisional strategies and goals. + **Team Management** : + Lead the BSH Design Assurance team, including managers and Design Assurance engineers. + Oversee activities, set goals, manage project resourcing, and provide guidance for product support. + Recruit, retain, and manage multiple direct reports, focusing on performance management, employee development, mentoring, and coaching to maximize engagement and productivity. + **Quality and Compliance** : + Promote awareness and efficacy of design control and risk management procedures/processes. + Drive continuous improvements through collaborative relationships with stakeholders. + Develop and oversee the application of design controls and risk management while supporting product development, manufacturing-related design changes, maintaining regulatory compliance, and enhancing manufacturability and cost efficiency. + **Operational Excellence** : + Direct activities, establish goals and objectives, define expected performance, and provide daily support and regular feedback regarding execution. + Assess the skillsets, competencies, and organization structure of the Design Assurance function, developing strategies and plans to meet current and future needs. + Consult with stakeholders to understand and plan for business strategies and needs. + **Guidance and Oversight** : + Provide guidance to managers and Design Assurance Engineers on design control compliance requirements, ensuring product inputs are clearly defined and design verification and validation activities are appropriate and compliant. + Address technical and project-based issues, assisting in the development of solutions and approaches for successful team alignment. + **Resource Management** : + Participate in resource planning and management for new product development, sustaining product support, and sustaining projects. + Collaborate with the divisional program management team, manufacturing sites teams, and design assurance team to ensure projects are clearly scoped, appropriately allocated, and aligned with divisional and company priorities. + **Ongoing Support and Improvement** : + Participate in ongoing product/project support activities, including sustaining project management, complaint review boards, real-time aging review boards, and design review committees. + Monitor the efficacy of design control and risk management processes and competency of personnel, identifying areas for improvement and building consensus on improvement initiatives. + Sponsor and coordinate improvements to established procedures and initiate new procedures as needed. + **Risk Management and Compliance** : + Accountable for risk management within the context of post-market surveillance, ensuring Risk Management files are up to date and Health Risk Assessments are initiated where appropriate. + Oversee Health Risk Assessments in evaluating on-market products, ensuring efficient and effective analysis of situations, including problem definition and benefit-risk profile consistency. + Promote awareness of design controls, user requirements, risk management, change control, and verification and validation processes across R&D and new development teams. **Qualifications:** + **Education** : + Bachelor's Degree in a technical Engineering field. + **Experience** : + 12+ years of experience with a Bachelor's Degree or 10+ years with a Master's Degree. + Expertise in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive. + Familiarity with ISO 14970, IEC 60601, IEC 62366, and EN 62304. + Experience with managing multi-source demands for project and product support, fostering an effective team environment. + Experience with Oracle or Agile is beneficial. + **Skills** : + Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements. + Thorough knowledge of Root Cause Methodologies, Risk Management, Lean Manufacturing, Kaizen, Kanban, Poke Yoke, and visual factory ideology. + Strong working knowledge of verification and validation requirements for regulated products and requirements analysis, including developing testable and measurable specifications. + Ability to assess product and project documentation as the principal advocate for compliance and effectively communicate assessments. + Proven ability to direct managers, supervisors, and individual contributors with varying experience levels across multiple products and projects. + Ability to develop and manage high-performing, motivated, and engaged teams. Familiarity with employee development and mentoring processes. + Demonstrates independent decision-making and prioritization, including resolving conflicts. + Lean-Six Sigma Green or Black Belt Certification is beneficial. + PMP Certification is beneficial. **So why join Hologic?** We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you! The annualized base salary range for this role is $167,400 - $297,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. **Agency and Third-Party Recruiter Notice:** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. **Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.** \#LI-Lb2
    $167.4k-297.6k yearly 60d+ ago
  • Scientist 2

    Hologic 4.4company rating

    Marlborough, MA job

    Why Hologic? Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence. What to expect: Performs functions which support the operation of the Scientific Product Support laboratory and executes internal, external, and cross-departmental studies for product development, new applications, and failure analysis. Operates sample preparation instrumentation, maintains supplies, completes necessary logs/records, and performs preventive maintenance on laboratory equipment. Must be comfortable in a laboratory environment working with various chemical and biological samples. Committed to high quality standards and timely completion of tasks; punctual Communicates clearly and accurately with others; works cooperatively in teams Organized; capable of multi-tasking Proficient in liquid pipetting and performing chemical dilutions Proficient in Microsoft Office and able to use advance statistical and data analysis software What we expect: Modifies and trains others to safety procedures and may develop engineering controls Develops and writes protocols and reports for moderate/highly complex studies Designs and executes moderately complex experiments to complete larger projects, including standard and factorial (DOE) experiments Completes project documentation following Quality System requirements Adheres to all laboratory and biohazard safety procedures Completes all required trainings on time Provides support for QC activities and may oversee laboratory work or manage individuals Participates in LEAN initiatives Identifies and mitigates external and customer issues Delivers presentations to internal and external groups Collaborates with outside groups on project related issues or studies May write/review papers for publication and contribute to development of intellectual property Analyzes, devises, and recommends methods to resolve problems Identifies new laboratory instrumentation based on project needs Monitors competition of tasks and projects Education & Experience: Bachelor's Degree required 6 years of laboratory experience with Bachelor's Degree 4 years of laboratory experience with Master's Degree 0-2 years of laboratory experience with PhD Hepatitis B vaccination required. The annualized base salary range for this role is $97,900 to $153,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.. Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-PR1 Must follow all applicable FDA regulations and ISO requirements. Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)
    $97.9k-153k yearly Auto-Apply 4d ago
  • Director, Payer Relations

    Hologic 4.4company rating

    Marlborough, MA job

    Marlborough, MA, United States As a leading innovator of women's health, Hologic is empowering people to live healthier lives everywhere, every day. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments. Hologic is seeking a Director, Payer Relations within the market access team to drive the payer engagement strategy and execution for our breast surgery portfolio in the United States. This role will be instrumental in optimizing reimbursement pathways, expanding coverage, and ensuring access across various sites of care. This role will work in close partnership with the broader market access team and will involve cross-functional coordination with teams including Commercial Marketing, Sales, Medical Relations, Health Economics & Outcomes Research, and Government Affairs. Successful candidates will have experience advocating for coverage and reimbursement with national and regional health plans in the U.S., ideally with a background in medical device, drug, radiopharmaceuticals, radiology or breast surgery. Candidates should possess strong communication skills, as well as an ability to analyze, interpret, and influence complex reimbursement landscapes. **Duties & Responsibilities** + Manage a network of key relationships with health plans across Commercial, Medicare and Medicaid + Develop and execute payer strategies to optimize access of target technologies and procedures. + Build out materials, tools, and messaging in partnership with internal teams to support payer objectives with medical directors and other key stakeholders + Educate key stakeholders on the clinical and economic benefits of the product portfolio + Monitor reimbursement trends and policies across assigned geography and accounts + Support hospitals and offices with billing and reimbursement inquiries **Qualifications and Experience:** + Bachelor's degree required, Advanced degree(s) preferred + 7+ years of experience in market access, payer relations, reimbursement, or a related field. + 5+ years of experience working with commercial payers + Demonstrated knowledge of U.S. national and regional payer landscape + Established relationships with national and regional payer accounts and highly skilled in relationship development + Hands-on experience with Medicare Part B reimbursement, hospital outpatient departments and physician office-based reimbursement + Experience presenting clinical and health economic data to payer and provider audiences + Collaborates with Hologic team members and physician champions to achieve desired outcomes. + Excellent organization and communication skills; demonstrated responsiveness to meet the needs of internal and external customers + Strong decision-making skills; ability to take initiative and act independently + Strong analytical thinking; ability to understand and synthesize complex information + Experience working with and managing external vendors + Preferred knowledge of drug-device combination products, radiopharmaceuticals, and innovative payment pathways (such as transitional pass-through payment) **Why join Hologic?** We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $150,300 to $267,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. **Agency and Third-Party Recruiter Notice:** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** \#LI-KM3
    $91k-122k yearly est. 25d ago
  • Lead Product Security Engineer (R&D Cytology)

    Hologic 4.4company rating

    Marlborough, MA job

    Marlborough, MA, United States San Diego, CA, United States Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day. Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a **Lead Product Security Engineer** and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a hybrid role based out of either Marlborough, MA or San Diego, CA. **Key responsibilities and applied experience required from a candidate:** + Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures. + Participate in continuous improvement of our Secure by Design principles and implementation, ensuring adherence to security standards and best practices. + Support the creation and maintenance of security design documentation and architecture diagrams. + Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle. + Define security requirements and controls based on specific use cases and threat models. + Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety. + Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs. + Establish automated processes for vulnerability scanning and remediation + Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments. + Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process + Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems. + Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents. + Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports. **Experiences that are nice to have:** + Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA, + GDPR, State and Federal security standards, and ACTS for premarket and post-market activities. + Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability. + Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution. **Minimum Requirements:** + Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent. + Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering + Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.) + Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences. + Skilled in working within cross-functional groups. + Skilled in performing Risk Assessment and Management plan + Skilled in writing design documentation and standard operating procedures. + Experience working in an FDA regulated environment is required. + Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities. + Strong verbal & written communication skills. + Familiarity with Windows OS and cloud-based solutions is required + Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team. + Proficiency in scripting and simple test automation (e.g., PowerShell, Python). The annualized base salary range for this role is $131,500 to $205,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand. **Why Hologic?** We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. If you have the right skills and experience, **apply today!** \#LI-RF1 #lead-level Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
    $131.5k-205.8k yearly 60d+ ago
  • Senior IT Solution Analyst, Global Supply Chain

    Hologic 4.4company rating

    Marlborough, MA job

    Marlborough, MA, United States Newark, DE, United States Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. There has never been a more exciting time to join us. Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful. Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare. We are rapidly growing and yet we have never been more focused - on our people, on our growth, on our future. -- Hologic is seeking a **Senior IT Solutions Analyst, Global Supply Chain,** to join our Plan to Make COE. In this role you will provide business process guidance, problem solving and on-going operational support to Global Planning and Manufacturing user community for Planning and Manufacturing and Supply applications. You will troubleshoot issues to determine a root cause and recommend/implement solutions, identify strategic benefits of current and future applications based on wider industry analysis and benchmarking. You must have the ability to work and build confidence with Senior Management on strategic improvements that can bring considerable value to Hologic. You will bring best practices and concepts for review and analysis and enable related strategic decisions. This is a hybrid role based in either Marlborough, MA, or Newark, DE. **Essential Duties & Responsibilities:** + Partner with Hologic's strategic Planning, manufacturing, and supply chain operations organizations to gain buy-in, identify opportunities to improve or implement new business processes and best practices. + Gather and evaluate business requirements, develop detailed functional specifications for potential business process improvements. + Advise and support current and future Manufacturing Execution System solutions based on strategic initiative and prioritized business projects that involve related solutions + Partner with assigned areas of the Planning and Manufacturing Supply Chain Operations on projects/tasks within our portfolio and related business applications. + Perform application setup and configuration in support of the implementation for the addition of new functionality. + Participate in testing and verification efforts for production releases, executing software unit test plans and verifying business User Acceptance Testing. + Understand and/or help to determine business main objectives and identify impact to other areas of the business while working with Reporting and Analytics COE. + Communicate with developers to ensure that requirements are translated to design specifications and appropriate testing efforts. **Required Qualifications and Experience:** + Bachelor's Degree in Management Information Systems, Engineering or Business Management, or related fields preferred + At least 8 - 12 years of progressive experience specific to Supply Chain, Manufacturing Operations, or Business Systems, ideally in regulated industries (medical device or pharmaceutical), and within manufacturing environment + Hands-on experience implementing or managing integrated business planning tools such as SAP IBP, Kinaxis Maestro, or other advanced planning and scheduling software. + Experience in global supply chain environments, including exposure to multi-site operations and cross-border logistics. + Proven track record of leading complex projects, process improvement initiatives, or system implementations. + Familiarity with Lean, Agile, or other continuous improvement methodologies. + Oracle Fusion Cloud EBS implementation experience + Experience in Enterprise Technologies for Enterprise Integrated Business Planning, Supply Chain Planning, Manufacturing, and Logistics such as Oracle EBS, SAP, and Kinaxis Maestro. + Experience and general knowledge of all Supply Chain functional areas such as Procurement, Order Management, Shipping, and Operational Costing. + Ability to gather and evaluate business requirements, develop detailed functional specifications for potential business process improvements. + Collaborate with both business partners and technical partners (internal IT and external partners) to determine business need solution approach. + Create and deploy standardized solutions across the entire supply chain, optimize internal processes, and provide strategic value for Hologic. + Demonstrated ability to manage a portfolio of multiple deliverables, enhancements, projects while achieving expected results. **Additional Preferred Qualifications:** + Concentrated Degree in Supply Chain Management, Business Administration, Industrial Engineering, Information Systems, or a related field. + Professional certifications such as APICS Certified Supply Chain Professional (CSCP), Certified in Production and Inventory Management (CPIM), Six Sigma, PMP (Project Management Professional), or similar supply chain/operations certifications. + Advanced coursework or training in data analytics, process optimization, or enterprise system implementation. The annualized base salary range for this role is $114,000 to $178,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand. **Why Hologic?** We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. If you have the right skills and experience, **apply today!** \#LI-RF1 #mid-level Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
    $114k-178.3k yearly 24d ago
  • Lead Product Development Engineer - Marlborough, MA

    Hologic 4.4company rating

    Marlborough, MA job

    Marlborough, MA, United States **Lead New Product Development (NPD) Engineer** Are you passionate about driving innovation in medical devices? Join our team as a Lead NPD Engineer, where your expertise and leadership will shape the future of surgical technology. **About the Role:** As the Lead NPD Engineer, you will spearhead the development of cutting-edge surgical devices, ensuring products meet clinical needs and exceed user expectations. You'll collaborate with multidisciplinary teams and bring your vision to life by translating customer insights into successful product strategies and outcomes. **Knowledge & Experience:** + Advanced degree (Bachelor's or Master's) in Systems, Biomedical, Mechanical Engineering, or related field. + Extensive experience (8+ years with Bachelor's, 6+ years with Master's) in new product development within the medical device industry. + Deep clinical and technical knowledge in gynecological surgery or related surgical technology. + Expertise in product architecture, specification development, and clinical application of medical devices. + Proven track record in leading complex product development programs from concept through to delivery. **Skills:** + Strategic thinker with ability to assess product risks and opportunities, guiding technical and business decisions. + Proficient in cross-disciplinary engineering, with knowledge of embedded systems and collaborative experience between hardware and software teams. + Strong ability to translate user feedback into technical requirements and validation methods. + Exceptional problem-solving and creative ideation skills, with a history of delivering impactful, market-ready solutions. + Outstanding verbal, written, and presentation communication skills, adaptable to technical and non-technical audiences. + Skilled in mentoring, knowledge sharing, and fostering continuous improvement within teams. **Behavior:** + Demonstrates sound judgment, initiative, and accountability in project leadership. + Builds and maintains effective relationships across functions, cultivating a collaborative and engaged culture. + Proactive communicator who keeps stakeholders informed and integrates diverse perspectives. + Champions innovation, actively contributing to intellectual property development. + Represents the voice of the end user throughout the development cycle. **Additional Requirements:** + Ability to travel up to 10% as needed. **So why join Hologic?** We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and an annual bonus scheme, one of our talent partners can discuss this in more detail with you. The annualized base salary range for this role is $119,300-186,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. LI-#LB2
    $119.3k-186.6k yearly 60d+ ago
  • NPD R&D Engineer 2 - Marlborough, MA

    Hologic 4.4company rating

    Marlborough, MA job

    The Product Development Engineer 2 applies strong technical expertise and customer-centric design principles to support new product development from concept through production. This role requires the ability to work both independently and collaboratively to solve moderately complex engineering challenges, contribute to project documentation, and support manufacturing transfer activities. Required Knowledge: In-depth understanding of engineering principles and practices relevant to biomedical or mechanical product development, particularly in the medical device industry. Knowledge of manufacturing processes such as machining, injection molding, rapid prototyping, and common joining methods. Familiarity with risk management tools, including the identification, assessment, and mitigation of risks throughout the product lifecycle. Understanding of design for manufacturability (DFM), geometric dimensioning and tolerancing (GD&T), and tolerance stack-ups. Proficiency in using CAD software; SolidWorks experience preferred. Awareness of experimental, computational, and analytical tools such as DFSS, statistical methods (DOE), and MiniTab. Required Skills: Ability to independently execute simple to moderately complex design and project tasks with attention to detail and quality. Strong technical problem-solving skills, with the capacity to formulate and resolve engineering challenges using sound technical judgment. Excellent technical writing skills, including the ability to prepare engineering reports, protocols, and validation documentation. Effective verbal and written communication abilities to interact with cross-functional teams, suppliers, customers, and contractors. Action-oriented with a drive for results and the ability to learn new technical concepts quickly. Competence in evaluating, selecting, and applying standard engineering techniques and procedures to project tasks. Required Behaviors: Customer-focused mindset, ensuring design solutions meet user needs and regulatory requirements. Collaborative team player, able to work effectively in multidisciplinary project teams. Proactive approach to learning and expanding technical skills across different areas. Adaptability, with the ability to receive and incorporate feedback and supervision appropriately. Detail-oriented and organized, capable of managing multiple tasks and priorities. Commitment to ethical practices, safety, and compliance standards. Required Experience: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field, with at least 2 years of relevant experience in research and development within the medical device industry, or Master's degree in a relevant field with 0-2 years of experience in health and/or business communities. Demonstrated experience supporting product development, from concept through to production and manufacturing transfer. Exposure to regulatory and quality requirements within the medical device industry is advantageous. Work Environment and Physical Requirements: Regularly required to sit, stand, walk, reach, handle objects, talk, and hear. Must possess close vision, color vision, and the ability to adjust focus. Ability to lift or move up to 25 pounds and work flexible hours as needed. Willingness to travel up to 10% as required. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. The annualized base salary range for this role is 76,800-120,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. LI-#LB2
    $82k-106k yearly est. Auto-Apply 20d ago
  • Principal Business Analyst, SAP Production Planning for Process Industries (PP-PI, EWM, TM)

    Lantheus Medical Imaging Inc. 4.7company rating

    Lantheus Medical Imaging Inc. job in Bedford, MA

    Job Description Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands. Summary of role We are seeking a Principal Business Analyst, SAP Production Planning for Process Industries (PP-PI, EWM, TM). This position is based in Massachusetts and requires a presence on-site (two/three) days per week, and open to applicants authorized to work for any employer within the United States. Lantheus operates and maintains a portfolio of manufacturing, supply chain and transportation systems. This role has lead configuration responsibilities for the platform. Detailed configuration scope includes the following: PP-PI Master recipe/phase/operation setup; resource capacities; material quantity calculation; control recipes; PI Sheets/XSteps; process messages; batch classification/derivation; goods movements (GI/GR) and confirmations; variance/settlement. EWM Warehouse structure (storage types/sections/bins), HU types, packaging specs; inbound/outbound processes; staging for process orders; wave/slotting; physical inventory/cycle counts; exception codes; RF framework. TM Dangerous goods master and checks; freight unit building; planning and carrier selection; tendering; event management; charge/settlement; alignment with EWM shipping and external documentation for radioactive shipments This Principal Business Analyst is expected to perform high-quality project and support work for his/her stakeholders, continue to build the SAP capability at Lantheus and foster its continued growth within the Lantheus' organization. Key Responsibilities/Essential Functions Manufacturing - PP‑PI (Process Orders) Own the PP‑PI design across process instructions (PI Sheets/XSteps), master recipes, phases, and resources; enable electronic batch records (EBR) with robust batch derivation/determination strategies. Build standard work for yield/variance handling, co‑/by‑products, rework, and stability studies; integrate with QM for in‑process controls, sampling, and usage decisions. Implement capacity planning/ATP integration and coordinate with MES/LIMS for confirmations and data collection; support serialization/traceability and regulatory reporting. Warehouse - EWM Architect EWM for radio‑pharma operations: storage type/bin strategies, HU management, putaway/picking, staging, wave management, and physical inventory/cycle counting; design packaging specifications for shielded containers and temperature‑controlled handling. Enable advanced inbound/outbound (IBD/OBD) flows, dock/yard management as needed, and exception handling; optimize replenishment and production staging (PP‑PI → EWM integration). Define RF process flows and user profiles; govern slotting/rearrangement for short‑lived isotopes and controlled materials. Transportation - TM (Nice to have) Configure TM for dangerous goods classification, compliant routing, freight units/orders, carrier selection/tendering, and cost calculation; integrate DG checks for IATA/ADR/DOT‑hazmat rules. Align TM with EWM shipping and radioactive generator shipment requirements, including palletization, routing, and weight hand‑offs to external systems. Quality, Compliance & Validation Design solutions aligned to cGMP, 21 CFR Part 11/Annex 11, GDP, and SOX controls; author configuration documentation and support validation (VP, IQ/OQ/PQ), change control, and audit readiness in GxP scope. Integration & Data Lead integrations across SAP (QM, MM, SD, GTS, FSCM), boundary apps (MES/LIMS, PLM, labeling/serial devices), and logistics partners; ensure master data stewardship (materials, batches, resources, recipes, BP, DG data). Partner with Finance on cost object flows (orders, cost centers, profit centers) and reporting alignment in S/4; collaborate on inventory/traceability and regulatory exports. Leadership & Delivery Serve as solution owner across PP‑PI/EWM/TM; drive roadmaps, govern design standards, mentor analysts, and guide vendor/partner work. Lead workshops, fit‑to‑standard, backlog grooming, and cutover/hypercare; maintain a culture of safety, quality, and continuous improvement. Requirements 8+ years SAP experience with 5+ years in S/4HANA/ECC across PP‑PI, EWM, and knowledge of TM, including at least 2 full‑cycle S/4 implementations. Deep configuration mastery (SPRO) in PP‑PI (recipes, phases, PI Sheets/XSteps, batch mgmt), EWM (storage types, HU, waves, slotting, packing specs, RF), and TM (DG settings, freight order management, tendering, charge mgmt). Demonstrated delivery in regulated (GxP) manufacturing environments with validated systems and audit trails. Hands‑on integration experience with QM, SD, MM, GTS; familiarity with MES/LIMS interfaces and electronic batch records; working knowledge of serialization and cold‑chain processes. Strong cross‑functional leadership, stakeholder management, and vendor orchestration; excellent documentation and communication skills. Preferred Requirements Experience in radiopharmaceuticals or life‑sciences manufacturing (isotope generators, sterile compounding, short‑half‑life products) and related dangerous goods compliance (IATA/ADR/DOT). Knowledge of PP‑DS for capacity‑constrained scheduling, IBP demand/supply integration, and advanced ATP; exposure to private‑cloud S/4 operations and Fiori role‑based UX. Prior work aligning job architecture and posting language with enterprise standards (Principal level). Core Values The ideal candidate will embody Lantheus core values: Let people be their best Respect one another and act as one Learn, adapt, and win Know someone's health is in our hands Own the solution and make it happen The pay range for this position is between $111,000 and $185,000 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until January 22th, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at ******************************.
    $111k-185k yearly Easy Apply 5d ago

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