Manufacturing Engineer

SoloPoint Solutions, Inc.; Menlo Park (CA); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

SoloPoint Solutions, Inc. in California seeks a highly experienced Manufacturing Engineer to design and validate catheter manufacturing processes, equipment, and fixtures.

You will troubleshoot production issues, drive efficiency improvements, and lead projects to enhance uptime, cycle time, and throughput. Collaboration with vendors for suitable equipment and support for development-to-commercialization scale-up, including process validation and transfer, will be key components of this role.

Formación

• Bachelor’s degree in engineering or related field.
• 8+ years of experience in medical device manufacturing in ISO 13485 and FDA environments.
• Proficient in root cause analysis and executing IQ/OQ/PQ process validations.
• Strong knowledge of SPC, CPK, and DOE for process optimization.
• Skilled in designing, testing, and implementing equipment, tooling, and fixtures.
• Familiar with design tools, prototyping techniques, and process evaluation methods.
• Demonstrated analytical abilities and decisive decision-making skills.

Responsabilidades

• Design and validate manufacturing processes, equipment, and fixtures for catheter production.
• Troubleshoot production issues and implement improvements for operational efficiency.
• Lead projects to improve production metrics such as uptime, cycle time, and throughput.
• Collaborate with vendors to select and develop equipment meeting manufacturing needs.
• Support scale-up from development to commercialization, including process validation and transfer.

Conocimientos

Root cause analysis

Process validation IQ/OQ/PQ

Statistical analysis SPC/CPK/DOE

Equipment/tooling/fixture design

Design tools & prototyping

Process evaluation methods

Analytical skills

Decision making

Educación

Bachelor’s degree in engineering or related field

Descripción del empleo

Qualifications

• Bachelor’s degree in engineering or related field
• Experience of at least 8 years in medical device manufacturing ISO 13485 and FDA environment
• Ability to perform root cause analysis and execute process validations (IQ, OQ, PQ)
• Understanding of statistical analysis (SPC, CPK, DOE)
• Skilled in equipment, tooling, and fixture design, testing, and implementation
• Knowledge of design tools, prototyping techniques, and process evaluation methods
• Strong analytical skills and decision-making ability

Responsibilities

• Design and validate manufacturing processes, equipment, and fixtures for catheter production
• Troubleshoot production issues and implement improvements for operational efficiency
• Lead projects to enhance production metrics such as uptime, cycle time, and throughput
• Collaborate with vendors to select and develop equipment suitable for manufacturing needs
• Support scale-up efforts from development to commercialization, including process validation and transfer