Mechanical Manufacturing Engineer

The Role

We are seeking a hands-on Mechanical Manufacturing Engineer to support Cala’s contract manufacturing partners and production operations. This role focuses on designing fixturing, improving assembly processes, and supporting production ramp and continuous improvement for our wearable medical devices.

Responsibilities

• Spend significant time working directly with contract manufacturers to observe builds, solve problems, and implement practical tooling and process improvements that increase quality, throughput, and operator ergonomics.
• Support Cala’s contract manufacturers with day-to-day production issues, process improvements, and line optimization.
• Design, prototype, implement and document assembly, test, and alignment fixtures.
• Develop and improve manufacturing processes to increase yield, reduce cycle time, lower scrap, and create process transferability.
• Partner closely with manufacturing teams at suppliers and at Cala to document and deploy new tooling and processes.
• Identify opportunities for automation or semi-automation.
• Support NPI and production ramp activities, including design transfer and validation.
• Aid in process validation (IQ/OQ/PQ) and related documentation.
• Collaborate with Quality, Operations, and Product Development to resolve manufacturing challenges.
• Provide on-site build support during critical production phases.

Requirements

• BS or MS in Mechanical Engineering
• Strong SolidWorks experience and hands-on mechanical design background
• 5+ years in manufacturing or manufacturing engineering (medical device preferred)
• Experience working directly with contract manufacturers
• Proven ability to design and implement production fixtures and tooling
• Experience with small electromechanical assemblies and plastics (injection molding, bonding, sealing)
• Familiarity with regulated environments (ISO 13485 / FDA QSR)
• Strong problem-solving skills and comfort working on the factory floor
• Clear communicator who works well across engineering, quality, and operations teams

Qualifications

• Currently authorized to work in the United States on a full-time basis
• Travel expectations: Approximately 20–40% time, primarily to manufacturing sites in the greater Minneapolis / St. Paul Metropolitan Area / Medical Alley as well as headquarters in San Mateo, CA. Travel may increase temporarily during critical build phases, production ramps, or issue resolution periods.

Benefits

• Compensation range: Market driven, with a salary range of $98,000 - $150,000
• Robust benefits package