Jobs at Hologic

• Develop an expert-level understanding of our products and how they’re used in clinical practice.
• Design, implement, and validate low-level device drivers for embedded platforms.

• Champion Security: Drive a Secure by Design culture across product teams, ensuring adherence to security standards and best practices.
• Policy Enhancement: Participate in the continuous improvement of our Secure by Design policies and procedures, aligning products with the latest security requirements and regulatory standards.

• Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP.
• Familiarity with root cause analysis tools, risk management principles, and compliance frameworks.

• Lead Advanced Manufacturing Engineer possessing excellent technical judgment and a deep understanding of design for manufacturability to lead the development, qualification, and transfer of manufacturing processes for new products.
• Technically leads advanced manufacturing engineering for large, complex projects, including the...

• Strong risk management and quality engineering skills, including experience with FMEA, hazard analysis, risk control strategies, and product lifecycle risk documentation.
• Knowledge of medical device regulations and standards such as ISO 14971, ISO 13485, FDA QSR, and EU MDR, with the ability to apply regulatory requirements in practical, product-focused ways.

• Senior Product Development Engineer possessing strong technical judgment and a deep understanding of customer centric design to support new product development from concept to production.
• Technically leads small to medium sized projects including one or more subsystem ownership while managing short & long term deliverables to meet project milestones.

• Leads high level architectural discussions to conceptualize clinical workflow and design solutions.
• Develops simulation models and analysis tools in MATLAB/Simulink to characterize system behavior, validate algorithms, and inform design decisions.

• Identify, assess, and prioritize opportunities to apply AI and computer vision within GYN surgical procedures and capital equipment, in collaboration with software, systems, and clinical engineering teams
• Translate clinical and workflow needs into well-defined technical problem statements with measu...

• Design, develop, test and maintain high-quality Embedded software applications using C and C++ programming languages.
• Design, develop, and validate algorithms for signal processing, real-time control (e.g., closed-loop energy delivery, motor and thermal control), and sensor fusion and tracking.

• Senior Product Development Engineer possessing strong technical judgment and a deep understanding of customer centric design to support new product development from concept to production.
• Technically leads small to medium sized projects including one or more subsystem ownership while managing short & long term deliverables to meet project milestones.

• Effectively communicate and sell the benefits of the APTIMA product line, the ThinPrep Pap Test and adjunctive testing, to clinicians in an assigned geographic territory
• Develop and execute a sales strategy within your assigned territory to meet and exceed sales goals. Insulate accounts against competition and regain lost customer accounts.

• Partner with the Director of Hologic Capital & Strategic Solutions and Strategic Sales team to execute and scale Hologic Capital strategies, programs, processes, tools, and commercial initiatives across the U.S.
• Serve as a key liaison between Hologic commercial teams and external lending partners, coordina...

• Bachelor’s Degree (Science degree preferred)
• 5+ years of diagnostics or medical sales experience; oncology preferred

• Business Partnership & Financial Planning
• Partner with Operations, Manufacturing, and Supply Chain leaders to support annual budgets, quarterly forecasts, and long-range planning activities.

• Supporting mechanical design activities for mammography, breast biopsy, bone densitometry, fluoroscan, and specimen radiography products.
• Creating 3D models, assemblies, and engineering drawings.

• Support the monthly close process for Operations cost centers, including journal entries, accruals, and account reconciliations.
• Prepare and analyze standard cost, inventory, freight, and manufacturing variance reports to identify trends and cost drivers.

• Product Development Engineer 2 possessing strong technical judgment and a sound understanding of customer centric design to support new product development from concept to production.
• Independently performs simple to moderately complex design and project tasks.

Position Summary:

The Primary Function of the Sr. Program Manager will be to work directly with a cross-functional team who is responsible for the development of new medical devices and systems in the Surgical Division to:

Lead small and large NPD projects from start to finish, coordinate D...

• Effectively communicate and sell the benefits of the APTIMA product line, the ThinPrep Pap Test and adjunctive testing, to clinicians in an assigned geographic territory
• Develop and execute a sales strategy within your assigned territory to meet and exceed sales goals. Insulate accounts against competition and regain lost customer accounts.

• Serve as a subject matter expert for CAPA, including root cause analysis, effectiveness checks, and sustainable corrective actions.
• Coordinate and facilitate CAPA Review Board meetings and related documentation.