Manufacturing Engineer II

Francis Medical - Maple, MN

Full-time - Mid Level

Maple, MN

Miscellaneous Manufacturing

About the position

The Manufacturing Engineer II role is a critical position within the organization, responsible for providing manufacturing operations representation and support throughout the product lifecycle and project phases. This role is essential in ensuring that all operations align with standard operating procedures (SOPs), regulations, and industry standards. The Manufacturing Engineer II will provide technical oversight to ensure that operational requirements are met, aligning both internal and external resources effectively. The position involves providing manufacturing line support, implementing lean manufacturing activities, and managing continuous improvement plans aimed at optimizing product quality, delivery, and cost within existing manufacturing processes. This role will report directly to the Manufacturing Operations and Supply Chain Manager and will work on projects that have a cross-functional impact, making collaboration and communication key components of the job. In this role, the engineer will participate as a core team member in product development projects, ensuring that manufacturability, scalability, mistake-proofing, and product cost considerations are integrated throughout the development process. The engineer will contribute to project plans by evaluating and providing input to the product development team, initiating and driving strategic initiatives to accomplish operational goals across all product development phases. A significant part of the role involves identifying, measuring, analyzing, and monitoring key performance indicators (KPIs) throughout the manufacturing process, troubleshooting and solving manufacturing issues and bottlenecks as they arise to enhance product quality and delivery. The engineer will document issues and recommend practical and timely solutions while identifying opportunities for process and yield improvements. The Manufacturing Engineer II will also be responsible for the development, improvement, and optimization of manufacturing processes and systems, focusing on cost reduction, material and product quality, and lean manufacturing principles. This includes implementing lean manufacturing initiatives such as process flowcharts, value stream mapping, single-piece flow, line balancing, and 5S methodologies. The engineer will assess manufacturing capacity capabilities to meet production demands and utilize six sigma methods to reduce variation and eliminate process waste. Additionally, the role involves reviewing and approving change requests associated with process improvements, ensuring components are designed for reliability and manufacturability, and supporting root cause analysis and action planning for non-conformance and corrective actions. The engineer will also play a key role in selecting and onboarding contract manufacturers, developing strong supplier relationships through site visits, and supporting the implementation of standard work for critical supplier processes. The position requires the creation of plans and reports that demonstrate technical rationale for decisions, as well as the development of new approaches and strategies for the company to evolve. Overall, the Manufacturing Engineer II is expected to be a self-directed, hands-on problem solver who can handle multiple tasks and projects simultaneously while maintaining high quality and timeliness of deliverables.

Responsibilities

• Participate as a core team member in product development projects to ensure manufacturability, scalability, mistake proofing, and product cost considerations.
• Contribute to project plans by evaluating and providing input to the product development team.
• Initiate, plan, and drive strategic initiatives to accomplish operational goals throughout all product development phases.
• Identify, measure, analyze, and monitor KPIs throughout the manufacturing process.
• Troubleshoot and solve manufacturing issues and bottlenecks to improve product quality and delivery.
• Document issues and recommend practical and timely solutions.
• Identify process and yield improvement opportunities and provide technical solutions.
• Work on the development, improvement, and optimization of manufacturing processes and systems.
• Implement lean manufacturing initiatives on internal and external manufacturing processes.
• Assess manufacturing capacity capabilities to meet production demand.
• Use six sigma methods to reduce variation and eliminate process waste.
• Review, initiate, and approve change requests associated with process improvements.
• Ensure components are designed for reliability, manufacturability, availability, and cost.
• Support NCMR and CAPA root cause analysis and action planning.
• Identify, select, and onboard contract manufacturers for sub-assemblies and finished goods.
• Develop excellent supplier relationships through frequent site visits.
• Support implementation of standard work for critical supplier processes.
• Improve supplier capabilities through process performance and equipment development work.
• Execute tools such as PFMEA, root cause analysis, control plans, and process validation.
• Utilize Design of Experiments (DOE) to refine and improve designs and processes.
• Analyze various assembly strategies and design concepts using DFMA principles.
• Create plans and reports that demonstrate technical rationale for decisions.
• Create and update product work instructions and train operation personnel.
• Coordinate efforts to plan, procure, install, and qualify tooling, fixtures, and equipment.
• Develop new approaches, methods, and strategies for the company.

Requirements

• Bachelor of Science degree in manufacturing, industrial, or mechanical engineering from an accredited college or university.
• Minimum of 3 years of manufacturing engineering experience, preferably within the medical device or a highly regulated industry.
• Experience in applying lean manufacturing concepts and methodologies such as continuous improvement, elimination of waste, 5S, kaizen, kanban, value stream mapping, and visual management.
• Demonstrated understanding, knowledge, and experience in manufacturing engineering principles such as Design for Manufacturing (DFM), PFMEA, DOE's, and process validations.

Nice-to-haves

• Experience in the application of statistical methods, tools, and analysis software (JMP / Minitab).
• Experience in structured problem-solving and root-cause analysis.
• Lean facilitator or practitioner certification.
• Lean Six Sigma Green Belt certification.
• Experience working in a fast-paced environment (small company/start-up).
• Experience with high-volume, single-use disposable manufacturing.
• Knowledge of cleanroom principles and standards.

Benefits

• Competitive salary and benefits package.