Manufacturing Engineer

Manufacturing Engineer (Level II)

This role leads the manufacturing lifecycle of products from prototype through pilot and full production, ensuring robust processes, high quality, and efficient transitions. The Manufacturing Engineer applies structured problem-solving and continuous improvement methodologies to optimize manufacturing performance, support new product introduction, and drive corrective actions across internal and external stakeholders.

Responsibilities include:

• Taking full manufacturing responsibility for assigned products, leading them through prototype, pilot, and production builds.
• Overseeing the implementation of customer documentation changes and internal change orders to ensure accurate and up-to-date manufacturing instructions.
• Reporting on the status of new product launch (NPL) activities, including progress, risks, and issues impacting manufacturing readiness.
• Using statistical tools to analyze process data and lead quality improvement initiatives within the customer team.
• Driving internal and external corrective action plans, ensuring timely resolution of issues and prevention of recurrence.
• Actively participating in new customer development and new business development activities by providing manufacturing input and support.
• Analyzing line return information to identify trends, understand root causes, and drive corrective actions on manufacturing process issues.
• Performing product-level testing and validation activities as required to support manufacturing and quality objectives.
• Performing Design for Manufacturability (DFM) reviews and collaborating with Test Engineering on Design for Testability (DFT) to ensure products are optimized for production and testing.
• Assisting in developing project proposals and associated cost estimates, providing manufacturing process and cost input.
• Executing a product's transitional manufacturing requirements and process approaches, ensuring smooth transfer from development to full-scale production.
• Developing in-depth knowledge of customers' products as required to support transitional activities and ongoing manufacturing support.
• Documenting and resolving moderately complex cross-departmental and cross-functional issues using structured problem-solving tools.
• Preparing and maintaining clear work instructions and process documentation to support consistent and compliant manufacturing operations.
• Communicating effectively with internal teams and external customers to provide updates, clarify requirements, and address manufacturing-related concerns.
• Supporting and promoting continuous improvement initiatives, including lean manufacturing and Six Sigma projects, to enhance efficiency and quality.
• Managing multiple tasks and priorities, taking on additional responsibilities as required to support production and business needs.

Essential skills include:

• Bachelor of Science degree in Engineering.
• Minimum of 5+ years of experience as a manufacturing engineer in a production setting.
• Manufacturing engineering experience, including ownership of manufacturing processes from prototype to production.
• Process engineering and manufacturing process development experience.
• Demonstrated ability to solve and document moderately complex cross-departmental issues using structured problem-solving tools.
• Engineering-level understanding of electronic components, circuits, and systems or mechanical components and systems, depending on education and experience.
• Experience with continuous improvement methodologies, including lean manufacturing and Six Sigma.
• Experience in process improvement and implementation of corrective and preventive actions.
• Project management experience related to manufacturing and new product introduction.
• Experience with assembly processes and development of work instructions.
• Strong written and verbal communication skills for internal and external customers.
• Effective interpersonal skills and ability to work with diverse groups.
• Effective multitasking skills with the ability to take on additional responsibilities as required.
• Strong organization and prioritization skills, with demonstrated high attention to detail.
• Ability to work with minimal supervision and guidance, exercising discretion, independent judgment, and professionalism.
• Understanding of and ability to use continuous improvement tools in a manufacturing environment.
• Strong customer service orientation and client focus.
• Working knowledge of productivity tools, including Microsoft Office products.
• Ability to use web-based conferencing tools such as Web Ex for communication and collaboration.

Additional skills and qualifications include:

• Experience in medical device manufacturing or similarly regulated industries.
• Lean Six Sigma experience or certification.
• Experience supporting Design for Manufacturability (DFM) and Design for Testability (DFT).
• Experience assisting with project proposals and cost estimation for manufacturing activities.
• Experience in analyzing line return information and driving process-related corrective…