Sr Manufacturing Engineer

Vitalpath - Cokato, MN

Full-time - Mid Level

Cokato, MN

About the position

The Sr. Manufacturing Engineer plays a pivotal role in leading initiatives that support the daily operations of products, processes, materials, and equipment. This position is crucial for the integration of new products into production, ensuring that timelines and production goals are met across various metrics, including safety, quality, cost, delivery, and productivity. The engineer will collaborate with cross-functional teams to evaluate, troubleshoot, and implement manufacturing processes, ensuring the production of high-quality products at a low cost. In this role, the engineer will be responsible for the comprehensive support and troubleshooting of the manufacturing process, directly participating in managing Continuous Improvements (CIs), quality issue investigations, and Non-Conformance Reports (NMRs) to ensure compliance with FDA Quality System Regulations (QSR) and applicable ISO 13485 requirements. Adherence to the VitalPath Quality Management System (QMS) is essential, including the development and maintenance of necessary documentation. The engineer will work in a collaborative environment with various departments such as Process Development, R&D, Production, Quality, and Supply Chain on complex projects to meet customer requirements regarding timely delivery and pricing. They will consistently generate innovative solutions to complex problems, support troubleshooting of equipment and manufacturing processes, and design, plan, and analyze production methods to eliminate waste and enhance user-friendliness. The engineer will ensure that new products introduced to the production floor align with business, quality, output, and cost objectives, while also designing and coordinating engineering tests and experiments, summarizing and analyzing test results, and communicating findings to technical and leadership audiences. Additionally, the engineer will manage project goals and progress, recommend revisions as necessary, assess the feasibility of proposed tests and products, and contribute to the development of the Business Unit's multi-year strategy. Training team members, including engineers and technicians, is also a key responsibility, as is participating in the development of junior staff through guidance and mentorship. The engineer will develop bills of materials (BOM), update work instructions, create tooling and fixtures to improve manufacturing processes, and assist in training Product Builders on processes related to the design and manufacture of medical catheters. Finally, the engineer will support and execute CI projects aimed at reducing costs and improving production yields.

Responsibilities

• Work in a cross-functional environment cooperatively with Process Development, R&D, Production, Quality, Supply Chain, etc. on complex projects to ensure success in delivering customer requirements of timely delivery and quoted price.
• Consistently generate innovative and unique solutions to complex problems of diverse scope to meet department goals.
• Support the troubleshooting of equipment and manufacturing processes.
• Design, plan, and analyze different aspects of the production methods to eliminate waste and create a user-friendly manufacturing process.
• Ensure that new products introduced to the production floor meet business, quality, output, and cost goals and objectives.
• Design and coordinate applicable engineering tests and experiments.
• Summarize, analyze, and draw conclusions from complex test results.
• Design and prepare engineering reports and communicate results to technical and leadership audiences.
• Coordinate, manage, and document project goals and progress and recommend appropriate revisions.
• Assess the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
• Lead in the identification, implementation, and management of Business Unit goals and actively contribute to the development of the Business Unit's multi-year strategy.
• Train team members, including engineers, technicians, and product builders on specific tasks.
• Participate in the development of junior staff by setting an example, providing guidance, and offering counsel.
• Develop bills of materials (BOM) and method of manufacture (MOM), update work instructions, and provide any needed training to technicians and assemblers related to processes and equipment.
• Create tooling and fixtures to improve the manufacturing processes and ease the operator's job in the assembly area.
• Assist in training Product Builders to processes associated with the design and manufacture of medical catheters.
• Support and execute CI projects to reduce costs and improve yields in the production area.

Requirements

• Bachelor's degree in Engineering or a related field.
• 5+ years of experience in manufacturing engineering or a related field.
• Strong knowledge of FDA QSR and ISO 13485 requirements.
• Experience with process development and troubleshooting in a manufacturing environment.
• Proven ability to work collaboratively in a cross-functional team setting.
• Excellent problem-solving skills and ability to generate innovative solutions.
• Strong communication skills, both written and verbal.
• Experience in training and mentoring junior staff.

Nice-to-haves

• Experience in the medical device industry.
• Familiarity with Lean Manufacturing principles and practices.
• Knowledge of Six Sigma methodologies.
• Experience with project management tools and techniques.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Professional development opportunities
• Flexible scheduling options