Manufacturing Process Engineer

We're looking for a motivated and collaborative Manufacturing Process 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 are excited to 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

The primary responsibilities of a Manufacturing Process Engineer include:

• Support day-to-day manufacturing operations through process control and improvement initiatives to minimize downtime and maximize production.
• Develop and implement new processes, process improvements, to improve process reliability and reduce customer complaints and costs.
• Work with cross-functional internal teams and external vendors to coordinate implementation of new equipment and processes to optimize production and increase capacity.

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

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Develop and implement new processes and process improvements which foster lean manufacturing principles
• Plan and coordinate the selection, procurement, installation, start-up, and qualification of new equipment/ technology, tooling, fixtures for manufacturing
• Innovate and define technical solutions for production, engineering or quality process-related concerns and lead efforts to realize the solutions
• Communicate/interface internally and externally to understand technical requirements, resolve issues, develop and maintain knowledge of equipment and processes
• Perform cost improvement projects, quality improvement projects, and equipment troubleshooting to support the Company’s manufacturing goals
• Perform and/or assist with root cause investigations associated with product/process non-conformances and implement robust corrective actions to prevent recurrence
• Collect and analyze process data to monitor process/equipment performance
• Lead and/or participate in cross-functional project teams, providing input to design control deliverables including project plans, design review requirements, and development of use, design & process FMEA’s
• Write protocols/reports, implement and lead process validation activities
• Write test methods and test method validation protocols/reports
• Perform and/or oversee equipment, test method validations and/or product testing
• Create, maintain and improve process documentation, work instructions and standard operating procedures
• Establish and implement effective preventive maintenance (PM) on equipment, as required

SUPERVISORY RESPONSIBILITIES

The Manufacturing Process 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 and/or EXPERIENCE

• Undergraduate degree (BA/BS) in mechanical, biomedical or other related field of engineering is required.
• A minimum of 3 years of manufacturing engineering experience is required
• Experience working with cross functional teams to successfully deliver projects in virtual/hybrid environments is required.
• Proficient in SolidWorks (CAD)
• Self-starter, able to work well within the group environment
• Solid organization skills with the ability to anticipate and adapt to changing situations
• Excellent verbal and written communication skills are required.
• Proficiency in MS Word, PowerPoint, Excel, and Teams/SharePoint is required
• Knowledge of FDA and ISO standards is preferred
• Smartsheet experience is preferred

LANGUAGE SKILLS

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

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee will be required to occasionally travel to clinical trial sites.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.