Manufacturing Process Engineer
About The Position
Delcath is seeking a motivated and collaborative Manufacturing Process Engineer to support manufacturing operations and improve production processes. The role focuses on process control and continuous improvement to minimize downtime, maximize production, improve reliability, and reduce customer complaints and costs. The engineer will work with internal cross-functional teams and external vendors to implement equipment and process changes that optimize production and increase capacity. The job description covers multiple levels within the same role; level and responsibilities will be commensurate with the individual's experience and qualifications. The position may include supervisory responsibilities for members of the engineering group and temporary product testers. The role requires an undergraduate degree in mechanical, biomedical, or another related engineering field, and at least three years of manufacturing engineering experience. Experience delivering projects with cross-functional teams in virtual or hybrid environments, proficiency in SolidWorks and Microsoft Office applications, and strong organizational and communication skills are required. Knowledge of FDA and ISO standards and experience with Smartsheet are preferred. The role may occasionally require travel to clinical trial sites.
Requirements
- Undergraduate degree (BA/BS) in mechanical, biomedical, or another related engineering field.
- At least 3 years of manufacturing engineering experience.
- Experience working with cross-functional teams to successfully deliver projects in virtual or hybrid environments.
- Proficiency in SolidWorks (CAD).
- Self-starter who can work well within a group environment.
- Strong organizational skills and the ability to anticipate and adapt to changing situations.
- Excellent verbal and written communication skills.
- Proficiency in MS Word, PowerPoint, Excel, and Teams/SharePoint.
- Ability to read and interpret technical journals, safety rules, operating and maintenance instructions, and procedure manuals; write routine reports and correspondence; and speak effectively with employees and outside organizations.
- Ability to perform basic arithmetic and calculate rates, ratios, and percentages, and create or interpret spreadsheets and graphs.
- Ability to occasionally travel to clinical trial sites.
- Ability to sit, stand, or walk; talk or hear; use hands to handle or feel; reach with hands and arms; perform repetitive wrist, hand, or finger motions; and occasionally lift or move up to 10 pounds.
Nice To Haves
- Knowledge of FDA and ISO standards.
- Smartsheet experience.
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 foster lean manufacturing, improve process reliability, and reduce customer complaints and costs.
- Plan and coordinate the selection, procurement, installation, start-up, and qualification of new manufacturing equipment, technology, tooling, and fixtures.
- Define technical solutions for production, engineering, or quality process concerns and lead efforts to implement them.
- Communicate and coordinate internally and externally to understand technical requirements, resolve issues, and maintain knowledge of equipment and processes.
- Perform cost and quality improvement projects and troubleshoot equipment in support of manufacturing goals.
- Conduct or assist with root cause investigations into product or process non-conformances and implement corrective actions to prevent recurrence.
- Collect and analyze process data to monitor process and equipment performance.
- Lead or participate in cross-functional project teams, contributing to project plans, design review requirements, and use, design, and process FMEAs.
- Write protocols and reports, and implement and lead process validation activities.
- Write test methods and test method validation protocols and reports.
- Perform or oversee equipment and test method validations and product testing.
- Create, maintain, and improve process documentation, work instructions, and standard operating procedures.
- Establish and implement preventive maintenance for equipment as required.
- May supervise other members of the engineering group and temporary product testers as required.
Benefits
- Comprehensive health plan.
- 401(k).
- Professional development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
