Manufacturing Engineer

As a Manufacturing Engineer, you will support the Interventional Urology implantable manufacturing by developing and implementing manufacturing procedures, methods, equipment, and processes that optimize labor and material utilization while adhering to regulatory requirements.

• Identify and justify opportunities for equipment upgrades, process improvements, and continuous improvement initiatives.
• Perform equipment, process, and product performance qualifications and validations, including risk assessments.
• Conduct statistical analysis and report results in technical protocols/reports conforming to FDA standards.
• Conduct root cause analyses and provide resolutions for manufacturing issues.
• Manage projects, including capital expenditures, to ensure they are completed on schedule and within budget.
• Perform necessary functions for purchasing, installing, and checking out new equipment.
• Plan, implement, and document designed experiments to support equipment upgrades and process improvements.
• Ensure GMP compliance of manufacturing equipment and processes.
• Support maintenance activities utilizing engineering and technical knowledge.
• Document new and existing procedures related to the manufacturing process.
• Mentor and assist lower-level engineers through projects.
• Conduct business to the highest ethical and professional standards, complying with applicable laws, regulations, and company policies.
• Other duties as assigned.

• Bachelor’s degree in engineering or a related field.
• 2+ years of related manufacturing work experience.
• Self-motivated and self-managed within a dynamic and collaborative team environment.
• Strong analytical and problem-solving skills, including the use of statistical analysis and continuous improvement methodologies.
• High-performing individual who can accept challenges and opportunities as they arise.

• Advanced written and oral communication skills.
• Advanced computer skills, including proficiency in Microsoft Office Suite (Access, Word, Excel, PowerPoint), Minitab, and SolidWorks.
• Knowledge and capabilities in the fabrication and design of mechanical parts, tools, and assemblies.
• Knowledge of risk assessment principles.
• Knowledge of design for manufacturing (DFM) methodologies.
• Advanced decision-making skills.
• Preferred Six Sigma Green Belt/Black Belt certification.
• Ability to effectively interact with various internal and external customers and vendors.
• Ability to convey a positive and professional image to internal and external customers.
• Ability to apply multidisciplinary problem-solving approaches to production and quality problems.
• Ability to exercise sound judgment to resolve manufacturing issues.
• Ability to work independently and with team members.
• Ability to multi-task and prioritize multiple projects.
• Ability to work in a fast-paced dynamic environment.
• Ability to communicate and train cross-functionally at every level of the business.

The role is based onsite with core working hours, offering some flexibility for start and stop times if needed.

This is a Contract position based out of Minneapolis, Minnesota.