Senior Manufacturing Engineer, Capital Equipment — Robotics

imperativecare; Campbell (CA); On-site; USD 125,000 - 145,000; Full time

Benefits offered by this job

401k plan

Health benefits

Generous PTO

Parental leave program

Job summary

Imperative Care in Campbell, CA, is seeking a Sr Manufacturing Engineer for capital equipment to lead in-house manufacturing activities and drive technology transfer from design to scalable production. This on-site, full-time role collaborates with R&D, Quality, and Supply Chain to ensure compliant, efficient production of complex electromechanical capital equipment.

Ideal candidates will have a BS in engineering with 5+ years in regulated medical device industries, and experience with GMP/GDP,

Qualifications

• BS in Engineering or related discipline with 5+ years in medical device or regulated industry.
• Experience setting up pilot/production lines and validating in controlled environments.
• Familiar with FDA QSR, ISO 13485, ISO 9001, and MDD regulatory frameworks.
• Experience with surgical robotics or complex electromechanical capital equipment preferred.
• Knowledge of GMP and GDP procedures and working independently or in teams.

Responsibilities

• Execute in-house and contract manufacturing activities meeting plans and quality/regulatory requirements.
• Collaborate with Supply Chain to ensure material availability for builds.
• Develop MPI/Manufacturing processes and LHRs with R&D and Quality.
• Create manufacturing specifications and coordinate IQ/OQ/PQ validations.
• Train MPI staff and plan equipment/workflow layouts; manage calibration and maintenance.

Skills

Pilot/production line setup

Validation

Independent/teamwork

Education

BS in Engineering or related discipline

Tools

FDA QSR

ISO 13485

ISO 9001

Job description

Imperative Care in Campbell, CA, is seeking a Sr Manufacturing Engineer for capital equipment to lead in-house manufacturing activities and drive technology transfer from design to scalable production. This on-site, full-time role collaborates with R&D, Quality, and Supply Chain to ensure compliant, efficient production of complex electromechanical capital equipment.

Ideal candidates will have a BS in engineering with 5+ years in regulated medical device industries, and experience with GMP/GDP,