Manufacturing Engineer - Katalyst Healthcares and Life Sciences : Job Details

Job Description: You are a problem solver. Complex projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team, you are always ready to tackle a project and work hard to find solutions. Your talent is needed across a wide variety of industries. As a Manufacturing Engineer, you have a wide array of career choices but are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission. Responsibilities:

• We are a team of inquisitive individuals who embrace a collaborative environment to take on sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment. Together, we build and maintain a positive work environment.
• Our team is dedicated to quality. Delivering life-saving products is about getting them right, and our technical expertise and experience working in a manufacturing environment empower us to meet that challenge.
• When you join us, you will work with a team of committed individuals who trust each other to deliver on the tasks at hand. We support innovation and out-of-the-box thinking balanced with collaboration across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development.
• Member of cross-functional Electronics Gemba Team with responsibility for up to 8 medical device manufacturing assembly lines.Execute Process and Equipment Validation/Verification Strategies for new or changing manufacturing process elements.
• Execute Engineering Builds and assist with Material Qualification Planning to support new or changing component requirements.
• Works with project teams and established work processes and proactively finds creative methods to reach desired performance levels.
• Represent manufacturing on R&D project core teams, responsible for deliverables, collaborating with internal stakeholders and ensuring productivity.
• Develop and maintain manufacturing process documentation including but not limited to: Manufacturing Process Specifications, Device History Records, Tooling/Equipment Specifications, Preventative Maintenance and Calibration procedures through Engineering Change Management (ECM) process.
• Perform and document root-cause analysis for Non-Conforming Material Reports.
• Summarize and report on departmental Safety, Quality, Delivery, Productivity, and Cost performance measures.
• Use Lean/Six Sigma methodology to identify and drive Continuous Improvement Projects to enhance Safety, Quality, Delivery, Productivity, and Cost performance measures.
• Perform and document Impact Assessments and Corrective Actions for Equipment Remediations associated with out-of-tolerance calibration results.
• Proactively identify and address safety-related issues through Near Miss Reporting Process.
• Review product designs with R&D, Sustaining, and AME engineers for optimized manufacturability and ease of assembly, from raw material to finished products.
• Leverage Subject Matter Experts during problem-solving exercises. Provide multiple what-if scenarios to find the best total cost solution with financial impacts and emphasis on delivery timelines.
• Use existing tools and best practices to report and track product and process metrics.
• Inform others proactively about developments or issues that affect their work, and their ability to meet commitments.

Requirements:

• Bachelor's Degree in Engineering.
• 0-2+ years of experience.
• Experience in the Medical Device or a similar regulated industry.
• Knowledge or experience in SAP, CAD modeling, schematic drafting, and electrical design knowledge is a plus.
• Knowledge or experience in computer-based automated testing.