Staff Manufacturing Engineer

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 is developing technology that will enable all healthcare providers to do more for their patients. Our platform combines real-time imaging, robotics, and artificial intelligence to make precise and consistent intervention more accessible. Our aim is to eliminate barriers in the patient journey, accelerate recovery, delight customers, and reduce cost of care.

About the Opportunity

As a Staff Manufacturing Engineer, you will lead manufacturing engineering for the internal production of complex electromechanical assemblies and drive partnerships with our external manufacturing network. This role will own the technical relationship with existing contract manufacturers and lead the identification, qualification, and onboarding of new manufacturing partners. This engineer will develop, transfer, and continually improve robust, scalable manufacturing processes for our capital equipment, and partner with R&D, Operations, Supply Chain, and Quality to achieve production goals across quality, delivery, cost, and scale.

What You’ll Do

• Own the technical relationship and manufacturing performance of contract manufacturing partners.
• Plan and execute manufacturing transfers between internal production and external partners, as well as between contract manufacturing sites.
• Partner with R&D early in product development to drive DFM/DFA, define manufacturing strategies, and ensure new assemblies are ready 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 manufacturing ramp activities.
• Establish clear transfer plans, schedules, risks, deliverables, and acceptance criteria to ensure continuity of supply and successful production handoffs.
• Drive improvements in quality, yield, delivery, capacity, cycle time, and cost across the external manufacturing network.
• Define and monitor manufacturing performance metrics, identify emerging risks, and ensure timely escalation and resolution of issues.
• Collaborate across R&D, Operations, Quality, Supply Chain, and external partners to align technical requirements and drive manufacturing decisions.

Desired Skills & Experience

• Bachelor’s degree in mechanical engineering, manufacturing engineering, electrical engineering, or a related technical field.
• 8+ years of experience in manufacturing engineering, NPI, industrialization, supplier manufacturing, or a related discipline.
• Demonstrated experience transferring complex electromechanical assemblies between internal production and contract manufacturing sites.
• Experience identifying, evaluating, qualifying, and onboarding contract manufacturers or other strategic manufacturing partners.
• Strong knowledge of electromechanical assembly, production tooling, fixtures, test equipment, inspection methods, and manufacturing 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 R&D, Operations, Supply Chain, and Quality.
• Experience with Linux and software for manufacturing
• Strong written and verbal communication skills, including the ability to communicate technical requirements and risks clearly across internal teams and external partners.
• Experience manufacturing FDA-regulated medical devices or other products in a highly regulated industry.

Position Logistics

• This position is required to be on-site at Mendaera HQ in San Mateo.
• Travel to visit suppliers and contract manufacturers domestically and internationally will be required.
• The annual salary range for this position is $140,000 to $180,000.
• Mendaera offers comprehensive medical, dental, and vision coverage, as well as a 401k with a company match.