Product Development Engineer
Job in
Queensbury, Warren County, New York, 12804, USA
Listed on 2026-06-04
Listing for:
Delcath Systems, Inc.
Full Time
position Listed on 2026-06-04
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering, Product Engineer, Medical Device Industry
Job Description & How to Apply Below
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 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.
Continuous Improvement
* 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…
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×