Manufacturing Engineer

Job Title : Manufacturing Engineer

Location : Salt Lake City, Utah

Department : Operations

Reports To : Director of Operations

Job Summary :

We are seeking a highly skilled and motivated Manufacturing Engineer with a strong background in lean manufacturing to join our team.

The ideal candidate will be responsible for designing, developing, and optimizing manufacturing processes for MTI Class 1 medical devices, ensuring that products meet regulatory and quality requirements.

The Manufacturing Engineer will also provide recommendations regarding product design and manufacturability. This role requires collaboration, communication skills, and a focus on process improvements to enhance efficiency and product reliability.

Key Responsibilities :

Process Development and Optimization : Design, develop, and optimize manufacturing processes for class 1 medical devices, including equipment selection, process flow, and layout.

Implement process improvements to increase manufacturing efficiency, reduce costs, and improve product quality. Participate in design reviews providing input and feedback on manufacturability and ease / cost of manufacturing based on design.

Use LEAN, Six Sigma, and other best practice tools for continuous improvement and problem resolution.

Regulatory Compliance : Ensure that all manufacturing processes comply with regulatory requirements, including FDA and ISO 13485 standards.

Support documentation requirements for regulatory submissions and audits. Ensure products are manufactured in accordance with pertinent IEC, CSA, AAMI, and other applicable government-regulated manufacturing standards

Process Validation and Verification : Develop and execute validation protocols to confirm that manufacturing processes and equipment are capable of consistently producing products that meet specifications.

Troubleshoot and resolve any process-related issues.

• Quality Assurance : Collaborate with Quality Team to develop and implement quality control measures. Perform regular audits and inspections to ensure adherence to quality standards and identify opportunities for improvement.
• Cross-Functional Collaboration : Work closely with Engineering, Quality, Supply Chain, Production, and other departments to support product development, resolve technical issues, and ensure smooth product transitions from development to manufacturing.
• Project Management : Lead and manage projects related to process improvements, equipment upgrades, and new product introductions.

Develop project plans, timelines, and resource requirements. Ensure projects are completed on time and within budget.

Training and Support : Provide training and support to manufacturing personnel on new processes, equipment, tools, and best practices.

Develop and maintain Standard Operating Procedures (SOPs) and work instructions.

• Data Analysis : Analyze production data to identify trends, track performance metrics, and drive decision-making. Use data analysis to identify corrective actions to address any deviations from production targets.
• ERP System : Provide input or feedback to Engineering on Bill of Materials (BOMs). Manage / input routs into ERP system.

Qualifications :

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or related field.
• 3 years experience in manufacturing engineering role or equivalent experience.
• Proven experience in implementing lean manufacturing principles and Six Sigma methodologies such as 5S (6S), Kaizen, and value stream mapping.
• Experience with process validation, equipment qualification, and quality control.
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and other engineering tools.
• Excellent problem-solving skills and the ability to work effectively under pressure.
• Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams. Strength in Excel, Outlook, Teams, and PowerPoint.
• Project management experience, with a proven track record of delivering projects on time and within budget.

Preferred Qualifications :

• Masters degree in mechanical engineering, manufacturing engineering, or related field.
• 5 years experience in manufacturing engineering role or equivalent experience.
• Certification in Lean / Six Sigma (Green Belt or Black Belt) or other relevant certifications.
• Strong knowledge of medical device regulations, including FDA and ISO 13485 standards.
• Proficiency in CAMWorks software.
• Experience with design controls and risk management in medical device development.
• Familiarity with industry trends and emerging technologies in medical device manufacturing.

Physical Requirements :

• Ability to work in a manufacturing environment, which may include standing for extended periods and lifting moderate weights.
• Capability to operate and maintain manufacturing equipment.

Company Overview :

MTI, Inc is a leading innovator in the medical device industry, dedicated to improving patient outcomes through advanced technology and quality products.

We offer a collaborative work environment, competitive compensation, and opportunities for professional growth and development.

We value our employees and understand how each individual contributes to our products, processes, and customer experience.

We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide a casual, friendly workplace and encourage employee growth and development.

Visit mti.net to learn more.

Benefits You'll Enjoy (full-time employees)

• Medical, vision, dental
• Health Savings Account (HSA) or Flexible Spending (FSA)
• 401k plan with employer match with vesting starting day 1
• Paid time off
• Paid holidays
• Annual bonus incentive
• $5250 annual education / tuition assistance
• Company events, lunches, and giveaways

Equal Opportunity Employer :

MTI, Inc is an Equal Opportunity Employer.