Manufacturing Engineer II, Capital Equipment: Scale

imperativecare; Campbell (CA); On-site; USD 102,000 - 120,000; Full time

Benefits offered by this job

Stock options

Bonus

401k plan

Health benefits

Generous PTO

Parental leave

Job summary

Imperative Care seeks a Manufacturing Engineer II for its Campbell, CA campus to drive manufacturability, scale-up, and technology transfer for complex capital equipment. This on-site, full-time role supports design-to-manufacturing handoffs and cost targets in a regulated environment.

You will contribute to prototype builds, process development, and quality-driven production, collaborating with R&D, QA, and supply chain to ensure on-time delivery and robust manufacturing processes.

Qualifications

• Bachelor’s degree in Engineering or related discipline with at least 2 years of related experience.
• Knowledge of and exposure to product testing and data collection.
• Excellent communications skills (written and verbal).
• Experience with quality systems such as FDA QSR, ISO 13485, and MDD.
• Experience in pilot/production line setup and validation is preferred.
• Familiarity with GMP, GDP procedures and requirements.
• Ability to work independently or in a team.
• Project management experience preferred.

Responsibilities

• Assist in construction of prototypes for new products/processes or current product enhancements.
• Provide support to in-house manufacturing activities to verify products are manufactured per plans and quality requirements.
• Coordinate with Supply Chain to verify material availability for planned builds.
• Develop MPI’s and LHR/DHR records in collaboration with R&D and Quality.
• Conduct time studies for each manufacturing process and identify improvement initiatives.
• Define in-process inspections with Quality and resolve yield issues via continuous improvement.
• Coordinate with cross-functional teams from concept through clinical testing.
• Maintain manufacturing tasks on project schedules and meet timelines and budgets.
• Participate in manufacturing team meetings to ensure clear communication.
• Build relationships with team members and staff.
• Prepare manufacturing specifications and coordinate all validation activities with Quality (IQ/OQ/PQ).
• Determine tooling and equipment needs for cost-effective manufacturing.
• Work with R&D to transition products into manufacturing while meeting targets.
• Collaborate with suppliers to ensure parts meet specifications.
• Review specs for sub-assemblies and final assemblies.
• Support manufacturing line and approve DCOs for manufacturing engineering.
• Assist in training MPI trainers and possibly train others.

Skills

2+ years experience

Strong communication

Quality systems exposure

Independent / team working

Pilot/production line setup

Education

Bachelor’s degree in Engineering

Job description

Imperative Care seeks a Manufacturing Engineer II for its Campbell, CA campus to drive manufacturability, scale-up, and technology transfer for complex capital equipment. This on-site, full-time role supports design-to-manufacturing handoffs and cost targets in a regulated environment.

You will contribute to prototype builds, process development, and quality-driven production, collaborating with R&D, QA, and supply chain to ensure on-time delivery and robust manufacturing processes.