Jobs at Hologic - Page 3

• Sculpting the strategic business plan to maximize Hologic’s market share. You will develop and manage sales funnels to analyze, track and provide accurate forecasts.
• Crafting long-lasting relationships with our new and existing customers, becoming a trusted advisor and partner to key decision makers.

• In-depth understanding of FDA Quality System Regulations, ISO 13485, Medical Device Directive, Medical Device Regulation, risk management, and cybersecurity management.
• Comprehensive knowledge of technical quality assurance and control systems, including standards, methods, and procedures for product inspection, testing, and evaluation.

• Work hands-on to implement state-of-the-art complaint and adverse event trending metrics and methods, including definition / optimization of complaint trending codes, analysis methods, and trending action limits
• Sustain routine monitoring and trending of product performance, complaint data, adverse event r...

• Design and develop code and documentation to support the creation of new features and functionality.
• Develop and maintain software under an Agile/Scrum/Continuous Integration methodology.

• Achieve defined sales goals and quota within assigned account list
• Maintain existing business by driving utilization and account independence

• In-depth understanding of Quality Management System (QMS) requirements and regulatory frameworks such as CLIA, CAP, NYSDOH, and state/federal regulations.
• Advanced knowledge of managing deviations, non-conformances, complaints, and Corrective and Preventive Actions (CAPA).

• Bachelor’s or Master’s in Electrical Engineering.
• 8+ years (Bachelor’s) or 6+ years (Master’s) in new product development, preferably in the medical device industry.

• Monitoring the industry for newly identified threats to cybersecurity and assessing the risk to Hologic products.
• Performing and documenting vulnerability assessments to malicious attacks on Hologic products and provide support to product teams.

• Lead the definition of system requirements, use cases, and interfaces based on customer, business, and regulatory needs.
• Develop and maintain system architecture, subsystem breakdown, and control documents.

• Serve as the primary financial advisor to senior stakeholders and business partners, delivering comprehensive financial data, interpretation, and actionable insights for informed decision-making
• Develop and maintain deep expertise in expense drivers and trends, linking financial data to business priorities and strategies

• Strong working knowledge of medical device and IVD regulations, including:
• cGMP

• Complaint Handling and Investigation:
• Receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR).

• Lead Cross-Functional Teams: Inspire, motivate, and empower high-performing teams to achieve program objectives while ensuring seamless collaboration across functions.
• Drive Program Success: Develop integrated schedules, identify critical paths, and implement robust risk mitigation strategies to deliver programs on time and within scope.

Lead Test Engineer responsible for designing, developing, and implementing cost-effective test methods and troubleshooting for complex hardware/software systems across all product development and manufacturing phases. Acts as a cross-functional technical expert and team lead, owning test strategi...

• Works with local sales and installation teams as the customer’s operational point of contact throughout the pre-install and physical installation phase
• Drives high-quality and on-time execution of capital shipments through consistent management of our capital orders

• Orchestration Expert: Deep expertise in Kubernetes (designing and troubleshooting clusters, not just using them) and container security.
• Automation Specialist: Advanced proficiency in CI/CD tooling (GitHub Actions, Azure DevOps, or Jenkins) and configuration management (Ansible/Terraform).

• Work closely with other test engineers, hardware/software developers and architects to develop an expert level of understanding of our products and their use in clinical practice to design, develop and test our next generation diagnostic systems. Promotes and contributes to the development of product knowledge throughout the organization.

• Team Leadership: Lead, mentor, and develop a high-performing, multi-disciplinary team responsible for sustaining engineering of on-market capital equipment.
• Product Lifecycle Management: Oversee all sustaining activities, including ongoing compliance, design changes, maintenance, and compliant testing.

• 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.

• 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).