Senior Lead Manufacturing Engineer

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 Senior Lead Manufacturing Engineer to join our team. As a uniquely qualified candidate, you will be responsible for production planning and inventory control for multiple products while prioritizing operations to ensure maximum performance and minimum delay. This individual will take a lead role in continuous improvement, product flow and capacity improvement to improve the overall efficiency of manufacturing while service level targets.

SUPERVISORY RESPONSIBILITIES:

Supervises:

• Manufacturing Technicians
• Manufacturing Engineers I, II and Staff

Key Responsibilities

• Ensure compliance with company and local Health, Safety, and Environmental (HSE) regulations and procedures.
• Document engineering activities following best practices and regulatory requirements.
• Collaborate with R&D, Design, and customers to understand product requirements.
• Perform visual inspections and ensure adherence to quality standards and work procedures.
• Drive cost-effective manufacturing by optimizing yield and material usage (BOM, consumables).
• Conduct root cause analysis and implement corrective actions for quality issues.
• Develop, implement, and improve manufacturing processes, methods, and efficiencies.
• Perform time studies, establish performance standards, and optimize workflows.
• Execute cost analysis (material, labor, overhead) and identify cost-reduction opportunities.
• Design and improve production layouts, equipment, tools, and fixtures.
• Develop and monitor process controls and support machinery modifications.
• Lead new product introductions (NPI), validations, and product transfers.
• Participate in design reviews and ensure safe, compliant process implementation.
• Provide technical leadership and coordinate work across engineering and technical teams.
• Build strong relationships with customers and suppliers.
• Investigate and resolve quality issues, ensuring timely and effective solutions.

Education & Experience

• Bachelor’s degree in engineering.
• Minimum 5+ years of relevant experience.
• Proven ability to serve as a Subject Matter Expert (SME), providing technical guidance, coaching, and hands-on training across cross-functional teams.
• Demonstrated leadership experience mentoring, developing, and influencing Technicians and Engineers at multiple levels, fostering technical growth, accountability, and continuous improvement.
• Excellent communication, collaboration, and interpersonal skills with the ability to effectively interact with leadership, engineers, technicians, and cross-functional stakeholders. English level B2+ required.
• Medical device industry experience is required
• Strong knowledge of quality systems and medical regulations (process validation, traceability, risk management)
• Expertise in manufacturing processes, tooling, layouts, and production equipment.
• Experience with Operational Excellence (OPEX) tools:
  • Basic: 5S, Kaizen, Pareto, Ishikawa, Control Charts, Histograms
  • Advanced: Lean/Six Sigma (Green Belt or higher preferred)
• Strong analytical, problem-solving, and decision-making skills.
• Ability to manage multiple priorities and work under pressure with minimal supervision.
• High attention to detail, accountability, and organizational ability.

This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.