Senior Manufacturing Engineer

MANIFEST Technology; Santa Clara (CA); On-site; USD 95,000 - 140,000; Full time

Job summary

MANIFEST Technology specializes in catheter extrusion and is seeking a Senior Extrusion Engineer to optimize tooling, processes, and machine parameters for compliant medical device manufacturing onsite. You will collaborate with customers, suppliers, and internal teams on prototypes, validations, and process improvements.

The role demands 5+ years in catheter extrusion, solid experience with ISO/QMS, and strong communication in English, with a focus on safety, quality, and regulatory adherence

Qualifications

• Bachelor's degree in Mechanical, Industrial, Biomedical, or related engineering.
• Minimum 5 years of catheter extrusion experience.
• Experience in extrusion, tooling, and machine maintenance.
• Experience with ISO Quality systems and World Class Manufacturing.
• Strong communication in English (verbal and written).

Responsibilities

• Read order specifications to determine machine adjustments.
• Adjust tooling and processing parameters within approved ranges.
• Interface with vendors for materials and equipment.
• Evaluate production equipment for productivity and quality.
• Observe machine operation to detect defects or malfunctions.
• Adhere to QMS, safety, and regulatory requirements.
• Collaborate to develop specifications and prototypes with customers and teams.
• Support project deliverables to meet metrics.
• Lead root-cause investigations and corrective actions.
• Train operators on machines and procedures.
• Update documentation through the ECN process.
• Perform IQ/OQ and validations.
• Ensure department efficiency, quality, and safety.
• Maintain reliable, punctual attendance.

Skills

Catheter extrusion

Extrusion processes

Tooling

Machine maintenance

English communication

Education

Bachelor's degree in Mechanical, Industrial, Biomedical, or related engineering

Tools

ISO Quality systems

World Class Manufacturing

Job description

MANIFEST Technology is actively seeking a Senior Extrusion (Catheter) Engineer to support onsite medical device (specifically catheter) manufacturing by optimizing extrusion processes, tooling, equipment, and machine parameters to ensure products meet approved specifications, quality standards, and regulatory requirements. This role collaborates with customers, suppliers, production, quality, and cross-functional teams on prototype development, process improvements, validations, root cause investigations, corrective actions, documentation updates, and operator training.

Duration

Full-time

Pay Range

$95,000 - 140,000 a year; W-2; No C2

PRIMARY RESPONSIBILITIES

• Read and understand order(s) specifications to determine machine adjustments and material requirements.
• Adjust tooling and processing parameters as allowed within the approved range(s), to produce products that meet approved specifications.
• Interface with vendors for raw materials and equipment
• Evaluate production equipment to ensure highest productivity and product quality
• Observe machine operation to detect work-piece defects or machine malfunction.
• Adhere to our client’s Values, Quality and Safety standards, Policies & Procedures, including but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security
• Management Systems, U.S. Food and Drug Administration (FDA) regulations, and other regulatory requirements.
• Collaborate with customers, suppliers, and internal cross-functional team members to: support the development of specifications, coordination of prototype fabrication of customer designed parts, and the transition of prototypes into manufactured components.
• Provide support on the execution of project deliverables to meet established metrics.
• Lead and/or assist investigations of root causes for product and process failures and establish corrective actions.
• Evaluate and perform alternative manufacturing methods according to the established guidelines.
• Provide process training for production operators, as needed.
• Update documentation as needed through ECN process.
• Perform IQ/OQ and Validations
• Train team members and new employees on machines and department procedures, as needed.
• Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness, and safety.
• Reliable, consistent, and punctual attendance is essential and required for the position.

QUALIFICATIONS & REQUIREMENTS

• Bachelor's degree in Mechanical, Industrial, Biomedical, or related engineering area OR equivalent combination of education and work experience.
• Minimum 5 years of catheter extrusion experience.
• Demonstrated experience in extrusion, tooling, and machine maintenance and process
• Experience with ISO Quality systems and World Class Manufacturing principles
• Must be able to communicate (verbal & written) and comprehend English