PEOPLE + CULTUREAt Delcath, every day begins with a profound opportunity to impact lives across the globe.

Here, your passion, whether it’s rooted in science, creativity, or digital expertise, becomes part of a larger mission to tackle some of the most significant medical challenges. Our collaborative environment is fueled by a collective drive to innovate and bring hope to individuals facing serious health conditions. As we continue to grow and evolve, we seek intellectually curious individuals eager to contribute their unique talents and make a significant mark. Come be a part of our dynamic team and start making a difference from day one.

OUR COMMITMENT TO PATIENTSWe are committed to providing safer, more effective, and minimally invasive therapies tailored to the unique needs of our patients.

Through our pioneering technology and innovative procedures, we strive to improve not just clinical outcomes but also the quality of life for those we serve. Our promise is to uphold the highest standards of care, ensuring each patient receives personalized treatment with the utmost compassion and respect. Together, we are setting new benchmarks in interventional oncology, fostering a future where liver cancer treatment is synonymous with precision, safety, and trust.

OUR VALUES

Our mission is to revolutionize the treatment of primary and metastatic cancers through groundbreaking therapies, and we are guided by a core set of values that inspire our work.

Innovation

Revolutionizing systems, shifting the paradigm

Results-oriented

Accountability and meeting commitments

Compliance

Operating within a given set of parameters to ensure quality and safety

Customer-focused

Meeting the needs of patients, physicians, and investors

Teamwork

Cross-functional trust, reliance and collaboration

Market Leadership

Leading with passion and focus, aiming to win

WHAT WE OFFERWe’re excited to provide a complete benefits package, including a comprehensive health plan, 401(k), and professional development opportunities, to support the well-being and growth of our employees and their families.

Employee stock purchase plan + 401k savings

Join our Employee Stock Purchase Plan and 401k to invest in your future with us. Learn more

Health, vision and dental insurance

Enjoy comprehensive health, vision, and dental insurance coverage for you and your family.

Professional development program

Advance your career with our robust professional development program.

Life, disability, and supplemental insurance

Get peace of mind with our life, disability, and supplemental insurance options.

Open Roles

Join our team at Delcath Systems and be part of pioneering the future of cancer treatment innovations.

Associate Director of Financial Planning & Analysis

Remote

We are searching for an experienced Financial Planning & Analysis (FP&A) Associate Director. This person will oversee Corporate Projections and provide monthly and quarterly budget to actual results to share internally and externally. We are looking for applicants with a strong analytical approach, tactical awareness, and excellent interpersonal skills.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Identify and comprehend Delcath’s business.
  • Team up with the various departments to develop the company’s financial and strategic plan.
  • Recommendation of an FP&A Reporting system and structure and the ability to implement it and train others to utilize it.
  • Evaluate and recommend modifications to projections and budgets.
  • Oversee and manage all aspects of fundamental financial planning and analysis, such as planning, spending, predicting, report generation, and other tasks.
  • Work with various business units to forecast income and expenses for the next few years.
  • Model long-term growth and determe the business elements that influence it.
  • Involvement in cost accounting projections and analysis for the commercial product(s)
  • Provide comprehensive review and commentary on cost center findings.
  • A Bachelor’s degree and at least 6-9 years of experience in finance, accounting, or a related field are required
  • Life Sciences related companies required; preferably clinical trial FPA experience

To apply for this position, please send your resume to jobs@delcath.com.

Project Quality Engineer

Queensbury, NY

The Project Quality Engineer is responsible for ensuring the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable FDA, ISO regulations and the Medical Device Directives/Regulations.

The Project Quality Engineer is responsible for providing quality project management and support for the Company by working with the Senior Quality Assurance Manager to assure proper GMP compliance within Delcath Systems.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Project Management – lead continuous improvements projects.
  • Participate on new product design teams as the design quality assurance engineer.
  • Support design verification, process validation, software validation and test method validation.
  • Generate procedures, specifications, and labeling as required.
  • Support the Corrective Action and Preventive Action Program.
  • Support the Internal Audit Program through the performance of audits as required.
  • Support the Supplier Quality Program and perform on-site quality audits, as required.
  • Support external regulatory audits.
  • Understand and communicate component and finished product specification requirements.
  • Support the Management Review process to monitor and evaluate Quality System effectiveness.
  • Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues as required.

To apply for this position, please send your resume to jobs@delcath.com.

Senior Quality Manager

Queensbury, NY

We are searching for an experienced Quality Manger for the oversite of the day-to-day medical device manufacturing activities including supplier control oversite, incoming and in-process quality inspection, NCR/CAPA/Complaint review approval and product release.  Provides direct tactical Quality support for multiple projects within Delcath Systems, Inc. to provide execution of the development, launch and post-approval maintenance of medical device components and finished medical devices according to the approved Design Control procedures.

ESSENTIAL DUTIES AND RESPONSIBILITIES 
  • In coordination with Senior Director of Quality, develop and execute quality and regulatory strategies and systems to comply with Quality System Regulations (QSR), Medical Device Directive (MDD), International Standards Organization (ISO), Recognized Consensus Standards and all other applicable quality system requirements. Ensure compliance to 21 CFR Part 820, 21 CFR Part 211, 21 CFR Part 4, ISO 13485, MDR 2017/745, UK MDR 2002, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Manage and maintain the effectiveness of the Delcath Quality Management System at the Queensbury sites and manage the resolution of all quality concerns and related issues as required. Act as the Deputy Management Representative for Queensbury.
  • Execute day-to-day processes for medical device manufacturing facility QA accountabilities to ensure continual regulatory compliance with FDA, Outside US Regulatory Authorities, and Notified Body and Approved Body requirements.
  • Provide oversight for product releases: finished products, raw materials, packaging components, and labeling.
  • Support the Corrective Action and Preventive Action Program.
  • Support the Internal Audit Program through the performance of audits as required.
  • Support the Supplier Quality Program and perform on-site quality audits, as required.
  • Support Customer Complaint investigations. Ensure Customer Complaint records are properly maintained, followed-up, and closed.
  • Support the Routine Metric Review and the Management Review process to monitor and evaluate Quality System effectiveness.
  • Maintain current knowledge base of all regulatory and quality assurance related changes within the industry.
  • Provide Quality leadership to development teams.  Represents the Quality discipline by providing support to all Sustaining Engineering Projects.
  • Work closely with internal regulatory staff and external consultants to prepare, review medical device manufacturing documentation for domestic and international paper-based and electronic regulatory submissions.
  • Collaborate with the Regulatory Team to recommend and implement regulatory strategies for product line extensions in support of product development team efforts and provide guidance to those teams to ensure that development activities are consistent with overall regulatory strategy.
  • Review and interprets technical and scientific data to ensure regulatory requirements are met; evaluates product/design and process changes for potential effect upon product safety and effectiveness; appropriately document Quality disposition of such changes.
  • Review and maintain Quality Systems programs to ensure continuous improvement and regulatory compliance.
  • Other duties may be assigned.

To apply for this position, please send your resume to jobs@delcath.com.

At Delcath Systems, Inc., we are committed to an inclusive environment where people can thrive. We seek to recruit, develop, and retain the most talented people from a diverse candidate pool. The company is proud to be an equal opportunity employer. We do not discriminate on the basis of race, gender, religion, age, sexual orientation, national origin, disability status, or any other characteristic protected by law. Our focus on diversity and inclusion is grounded in our company’s core values and is essential to our success.