Job Description:

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

Responsibilities:

• 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.
• Work with project teams and established work processes, proactively finding creative methods to achieve desired performance levels.
• Represent manufacturing on R&D project core teams, ensuring 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, Preventive 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 Remediation associated with out-of-tolerance calibration results.
• Proactively identify and address safety-related issues through the 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 Client on delivery timelines.
• Use existing tools and best practices to report and track product and process metrics.
• Proactively inform others 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 modelling, schematic drafting, and electrical design is a plus.
• Knowledge or experience in computer-based automated testing.

• 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.
• Work with project teams and established work processes, proactively finding creative methods to achieve desired performance levels.
• Represent manufacturing on R&D project core teams, ensuring 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, Preventive 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 Remediation associated with out-of-tolerance calibration results.
• Proactively identify and address safety-related issues through the 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 Client on delivery timelines.
• Use existing tools and best practices to report and track product and process metrics.
• Proactively inform others about developments or issues that affect their work and their ability to meet commitments