Product Development Engineer

Delcath Systems; Town of Queensbury (NY); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Health plan

401(k)

Professional development opportunities

Job summary

Delcath Systems is seeking a Product Development Engineer in New York. You will lead technical aspects of new product development and redesigns for disposable medical devices, coordinating across R&D, manufacturing, and QA to meet regulatory requirements.

The role involves design control activities, risk analysis, test method development, and support for process improvements and cost reduction initiatives.

Qualifications

• Bachelor’s degree in a relevant engineering field.
• 3-5 years of product development experience in medical devices.
• Experience with design controls and quality systems.
• Proficiency with SolidWorks CAD.

Responsibilities

• Lead design and development of medical devices in compliance with design controls.
• Maintain design documentation including DHF, requirements, and risk analyses.
• Perform design reviews and ensure traceability from needs to verification/validation.
• Support testing, data analysis, and validation activities across disciplines.

Skills

SolidWorks

Materials knowledge

Manufacturing processes

Medical device testing methods

Design controls

Cross-functional collaboration

Project teamwork

Education

Bachelor’s degree in mechanical engineering

Bachelor’s degree in biomedical engineering

Bachelor’s degree in electrical engineering

Related engineering field

Tools

Smartsheets

Minitab

Microsoft Office

Job description

We’re looking for a motivated and collaborative Product Development Engineer to join our growing team at Delcath. In this role, you’ll have the opportunity to make a meaningful impact while working alongside talented colleagues in a supportive and innovative environment.

We'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.

POSITION SUMMARY

This position’s primary responsibility is to lead technical aspects of new product development and/or re‑design of existing disposable medical devices to support the Company’s research and development goals. This person will execute technical and cross‑functional project work which may include efforts in all phases of research & product development, including research, design and development planning, requirements definition, solid modeling, root cause analysis, test method development/validation, and design verification/validation activities. This person will support efforts to improve product quality and manufacturing processes and will support continuous improvement initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES

include the following. Other duties may be assigned.

Product Design & Development

• Design and develop medical devices and components in compliance with design control requirements (e.g., 21 CFR 820, ISO 13485).
• Generate and maintain design documentation including requirements, risk analyses, drawings, specifications, and design history files (DHF).
• Perform tolerance analysis, material selection, and design for manufacturability.
• Source and purchase test and production equipment, develop equipment PM and calibration requirements, and complete test method validations.
• Participate in risk management activities, including hazard analysis, FMEA, and risk mitigation.
• Lead or support design reviews and ensure traceability from user needs through verification and validation.
• Investigate and resolve design‑related nonconformances, complaints, and CAPAs.

Cross‑Functional Collaboration

• Collaborate with Manufacturing Engineering to transfer designs into production, facilitate change management documentation, develop, troubleshoot and maintain manufacturing process equipment and systems.
• Collaborate with business stakeholders, including medical, commercial, marketing and operations to understand business and market needs.
• Collaborate with Regulatory Affairs to support submissions.
• Support supplier development, qualification, and technical communication.

Testing & Documentation

• Develop and execute verification and validation test protocols, including test methods.
• Perform data analysis and design of experiments and present results to technical and non‑technical stakeholders. Maintain accurate records in accordance with company procedures and regulatory requirements.
• Identify opportunities to improve product performance, reliability, and cost.
• Apply lessons learned and post‑market feedback to next‑generation designs.

SUPERVISORY RESPONSIBILITIES

The Product Development Engineer may have supervisory responsibilities for other members of the engineering group and may need to supervise temporary product testers, as required.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION/EXPERIENCE/SKILLS

Education

• Bachelor’s degree in mechanical engineering, biomedical engineering, electrical engineering, or a related field.
• A minimum of 8 years medical device research & development experience may substitute for degree

Experience

• 3-5 years of product development experience, preferably in the medical device or regulated industry.
• Experience working under formal design controls and quality systems.

Technical Skills

• Proficiency in SolidWorks (CAD)
• Proficiency in Microsoft Office (Word, Excel, Project), Smartsheets, and Minitab
• Knowledge of materials, manufacturing processes, and medical device testing methods.
• Familiarity with applicable standards (ISO 13485, ISO 14971, FDA QMSR).

Soft Skills

• Strong analytical and problem‑solving skills.
• Effective written and verbal communication.
• Self-starter with the ability to work independently and within cross‑functional teams.
• Solid organizational skills with the ability to anticipate and adapt to changing situations.

LANGUAGE SKILLS

Ability to read and interpret documents such as prints, technical journals, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine protocols/reports and correspondence. Ability to speak effectively with employees and outside organizations.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, heat, airborne particles, moderate noise and outside weather conditions.