Product Development Engineer

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.

This job description is intended to cover multiple levels within the same role. Level and responsibilities will commensurate with the individual's experience and qualifications.

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.

Risk Management & Quality

• 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 designrelated nonconformances, complaints, and CAPAs.

CrossFunctional 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 nontechnical stakeholders. Maintain accurate records in accordance with company procedures and regulatory requirements.

Continuous Improvement

• Identify opportunities to improve product performance, reliability, and cost.
• Apply lessons learned and postmarket feedback to nextgeneration 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 problemsolving skills.
• Effective written and verbal communication.
• Self-starter with the ability to work independently and within crossfunctional 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.