Manufacturing Engineer I

Job Description:

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We are looking for a Manufacturing Engineer I to join our team. In this role, you will develop, implement, and sustain manufacturing processes and production methods that ensure safety, quality, efficiency, and compliance with company and regulatory standards. You will analyze manufacturing data and technical issues, apply sound engineering judgment to identify solutions, and support continuous process improvements.

Working closely with Operations and Quality teams, you will help optimize production performance, resolve manufacturing challenges, and support new product introductions and process validations. You may also provide technical guidance and mentorship to junior team members while contributing to cross-functional projects and operational excellence initiatives.

Essential Duties and Responsibilities

• Ensure compliance with company policies and applicable Health, Safety, Environmental (HSE), and regulatory requirements.
• Document engineering activities in accordance with company procedures, engineering best practices, and regulatory standards.
• Collaborate with R&D, Design, Development, Transfer Engineering, and customers to support product manufacturing and new product introductions.
• Develop, validate, and optimize manufacturing processes, production lines, equipment, tooling, and fixtures to improve safety, quality, efficiency, and cost.
• Monitor and improve manufacturing performance through yield optimization, material utilization, time studies, workflow analysis, and continuous improvement initiatives.
• Perform root cause analysis and lead investigations to resolve manufacturing and quality issues.
• Support product transfers, process validations, and implementation of standard manufacturing methods.
• Build effective relationships with customers and suppliers to support manufacturing and quality objectives.

Education and Experience

• Bachelor's degree in Engineering (completed).
• Minimum of 1 year of engineering experience in a manufacturing environment.
• Working knowledge of Quality Systems and Medical Device regulations, including process validation, traceability, quality issue management, and risk management.
• Technical knowledge of manufacturing processes and methods, including tooling, workflow, production layout, assembly processes, and manufacturing equipment.
• Basic understanding of Operational Excellence (OpEx) and Quality tools, including 5S, Kaizen, Pareto Analysis, Ishikawa (Fishbone) Diagrams, Control Charts, Checklists, and Histograms.
• Knowledge of statistics, materials engineering, and mechanical principles is considered an asset.

Other Skills and Competencies

• Ability to develop subject matter expertise (SME) and effectively train and mentor others.
• Strong written and verbal communication skills, with the ability to provide clear, structured project updates.
• Ability to work effectively under pressure in a fast-paced environment.
• Strong analytical and critical thinking skills.
• Excellent teamwork and collaboration skills.
• High level of accountability and ownership.
• Strong attention to detail and commitment to quality.
• Excellent problem-solving and decision-making abilities.
• Proven ability to organize, prioritize, and manage multiple tasks simultaneously.