Staff Manufacturing Engineer

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.

Responsibilities

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

Requirements

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

Benefits

Comprehensive medical, dental, and vision coverage; 401k with a company match