Manufacturing Engineer II, Capital Equipment

About the role

This position is based in our Campbell, California offices. This position is on-site & full-time.

Responsibilities

• Uses strong hands-on experience to execute and deliver assigned projects/products to ensure manufacturability, supporting technology transfer from design to manufacturing and ultimately scalability for commercialization for complex electromechanical capital equipment.
• Completes projects related to in-house manufacturing, manufacturing engineering, and equipment planning/engineering in accordance with the company’s Quality System and customer requirements.
• Aids in the construction of prototypes for new products/processes or current product enhancements.
• Provides support to in-house manufacturing activities to verify products are manufactured in accordance with product plans and quality/regulatory requirements.
• Works with Supply Chain to verify inventory of raw materials and components are available per the planned build schedule, monitors and is accountable for material issued to production/projects.
• Develops manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) or Device History record (DHR’s) in collaboration with R&D and Quality.
• Conducts time studies for each manufacturing process and identifies process development initiatives.
• Collaborates with Quality personnel to define in-process inspections and testing and resolves quality and yield issues through continuous improvement projects.
• Informs and coordinates with multi-functional operations project team activities from early project conceptualization through clinical testing.
• Completes, maintains, and monitors manufacturing tasks of project schedule, ensuring that critical timelines and/or budgets are established and met.
• Participates in manufacturing team meetings to ensure communication between members.
• Builds positive proactive working relationships with team members and other staff members.
• Completes manufacturing specifications for products; coordinates all process validation activities with Quality- IQ/OQ/PQ.
• Determines tooling and equipment needs for the timely and cost-effective manufacture of products.
• Works with R&D staff to facilitate smooth transition of products into manufacturing while assuring manufacturability, achieving cost targets and conformance with regulatory and Company requirements.
• Collaborates with suppliers to ensure parts/services are properly documented and meet specifications.
• Supports manufacturing line and approves DCO’s for manufacturing engineering.
• Supports the training/certification of the MPI Trainer for manufacturing process instructions; may train other staff as needed.
• Using continuous improvement techniques, works with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliability.

Requirements

• Bachelor’s degree in Engineering or related discipline and minimum 2 years of related experience; or equivalent combination of education and work experience.
• Knowledge of and exposure to product testing and data collection.
• Excellent communications skills (both written and verbal) required.
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
• Experience in pilot/production line set-up, validation in a controlled environment is preferred.
• Familiar with GMP, GDP procedures and requirements.
• Ability to work independently or in team setting required.
• Project management experience preferred.

Qualifications

• Employee Benefits include a stake in our collective success with stock options, bonus, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Benefits

• Health benefits
• Grossly generous PTO
• A parental leave program
• Emotional health resources

Pay

Salary Range: $102,000 - $120,000 / annually

Schedule

Full-time