Staff Manufacturing Engineer: NPI & Transfer Leader

Mendaera, Inc.; San Mateo (CA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401k with company match

Job summary

Mendaera, Inc. is seeking a Staff Manufacturing Engineer to lead internal manufacturing of complex electromechanical assemblies and manage external contract manufacturers.

You will own transfers, set strategies with R&D, and build robust manufacturing packages to enable scalable production. You will collaborate across R&D, Operations, Quality, and Supply Chain to optimize quality, yield, delivery, and cost while ensuring readiness for FDA-regulated medical devices.

Qualifications

• Bachelor’s degree in mechanical, manufacturing, electrical engineering, or related technical field.
• 8+ years in manufacturing engineering, NPI, industrialization, supplier manufacturing, or related discipline.
• Experience transferring complex electromechanical assemblies between internal production and contract manufacturing sites.
• Experience identifying, evaluating, qualifying, and onboarding contract manufacturers or other strategic partners.
• Strong knowledge of electromechanical assembly, production tooling, fixtures, test equipment, inspection methods, and process controls.
• Experience developing and transferring manufacturing documentation, including assembly procedures, process flows, routings, inspection plans, PFMEAs, control plans, and training materials.
• Experience leading pilot builds, production readiness reviews, process validation, and manufacturing ramp activities.
• Strong working knowledge of DFM/DFA, root-cause analysis, corrective action, process capability, and statistical process control.
• Ability to lead complex, cross-functional manufacturing projects with limited oversight and drive decisions across multiple functions.
• Experience with Linux and software for manufacturing.
• Experience manufacturing FDA-regulated medical devices or products in highly regulated environments.

Responsibilities

• Own the technical relationship and manufacturing performance of contract manufacturing partners.
• Plan and execute manufacturing transfers between internal production and external partners, and between contract manufacturing sites.
• Partner with R&D early to drive DFM/DFA, define manufacturing strategies, and ensure readiness for external production.
• Develop and transfer complete manufacturing packages, including process flows, work instructions, routings, and inspection plans.
• Develop and transfer custom tooling and fixtures to support assembly.
• Lead pilot builds, process characterization, validation (IQ/OQ/PQ), production readiness reviews, and ramp activities.
• Establish transfer plans, schedules, risks, deliverables, and acceptance criteria for continuity of supply and handoffs.
• Drive improvements in quality, yield, delivery, capacity, cycle time, and cost across external network.
• Define and monitor manufacturing performance metrics, identify risks, and escalate issues.
• Collaborate across R&D, Operations, Quality, Supply Chain, and external partners to align requirements.

Skills

Contract manufacturing

DFM/DFA

Cross-functional leadership

Process characterization

Quality improvement

Root-cause analysis

Statistical process control

Project management

Manufacturing tooling

Communication skills

Education

Bachelor’s degree in mechanical manufacturing electrical or related field

Tools

Linux

Manufacturing software

Job description

Mendaera, Inc. is seeking a Staff Manufacturing Engineer to lead internal manufacturing of complex electromechanical assemblies and manage external contract manufacturers.

You will own transfers, set strategies with R&D, and build robust manufacturing packages to enable scalable production. You will collaborate across R&D, Operations, Quality, and Supply Chain to optimize quality, yield, delivery, and cost while ensuring readiness for FDA-regulated medical devices.