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About the Role
In this role, you'll have the opportunity to make a meaningful impact while working alongside talented colleagues in a supportive and innovative environment.
Responsibilities
- Support day-to-day manufacturing operations through process control and improvement initiatives to minimize downtime and maximize production.
- Develop and implement new processes and 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.
- 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.
Requirements
- The individual must be able to perform each essential duty satisfactorily.
- 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.
- 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.
- The employee will be required to occasionally travel to clinical trial sites.
- 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.
Skills
- 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
- Proficiency in MS Word, PowerPoint, Excel, and Teams/SharePoint
- Knowledge of FDA and ISO standards is preferred
- Smartsheet experience is preferred
Experience Level
- 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.
Education Level
- Undergraduate degree (BA/BS) in mechanical, biomedical or other related field of engineering is required.
Benefits
- Comprehensive health plan
- 401(k)
- Professional development opportunities
About the Company
- Delcath is a growing company.