Senior Manufacturing Quality Engineer

Axoft•Cambridge, MA

2d•$110,000 - $140,000•Onsite

About The Position

Axoft is seeking a Senior Manufacturing Quality Engineer to support the scale-up of regulated manufacturing for our implantable brain-machine interface technology. This role is focused on building practical, compliant manufacturing quality systems that help teams move from development into reliable production. Reporting to the Director of Quality Assurance, you will partner closely with Manufacturing, Engineering, and Operations to establish process controls, validation practices, documentation, inspection strategies, and quality workflows that are scalable for a Class II/III medical device environment. The ideal candidate brings strong manufacturing quality experience, comfort working hands-on in regulated environments, and the ability to collaborate across technical teams. Experience in cleanroom, microfabrication, or similarly complex manufacturing environments is valuable, but we recognize that candidates may bring this expertise from different backgrounds.

Requirements

Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, or related field) or equivalent technical discipline.
5–7 years of experience in manufacturing quality or quality engineering within the medical device industry.
Experience with Class II and/or Class III devices.
Strong experience working within FDA-regulated and ISO 13485-compliant QMS environments.
Hands-on experience supporting process validation, equipment qualification, process controls, and manufacturing documentation.
Solid understanding of medical device regulations, including 21 CFR Part 820 and ISO 13485.
Strong working knowledge of validation, process control, inspection methods, SPC, DOE, and root-cause analysis tools.
Ability to translate regulatory requirements into practical, scalable manufacturing processes.
Strong project management, communication, and cross-functional collaboration skills.
Hands-on, detail-oriented approach with the ability to balance rigor, prioritization, and speed in a growing organization.

Nice To Haves

Experience with cleanroom manufacturing, semiconductor, MEMS, nanofabrication, or other complex precision manufacturing environments is preferred.
Experience supporting design transfer, manufacturing scale-up, MRP/ERP implementation, or startup environments is a plus.

Responsibilities

Serve as the primary Quality partner for manufacturing, helping teams execute compliant, practical processes within the QMS.
Partner with Manufacturing and Engineering to define, qualify, and improve production processes, including process mapping, critical parameter identification, and control strategy development.
Support disciplined issue resolution by identifying root causes, implementing corrective actions, and reducing recurring manufacturing variability.
Plan and execute IQ/OQ/PQ activities for cleanroom equipment and manufacturing processes, ensuring documentation is audit-ready and aligned with regulatory expectations.
Establish process monitoring and control methods, including SPC, yield tracking, process capability metrics, and appropriate metrology or measurement-system analysis.
Help assess equipment capability, stability, preventive maintenance needs, and quality controls required for reliable production.
Develop and review manufacturing documentation, including work instructions, job travelers, SOPs, test methods, inspection criteria, and sampling plans.
Support incoming, in-process, and final inspection strategies, material traceability, disposition processes, and inventory-related quality controls.
Contribute to MRP/ERP workflows that support traceability, QMS requirements, training, and audit readiness.
Partner with R&D, Manufacturing, Operations, and Quality to translate development processes into controlled, repeatable production practices.
Support design transfer deliverables, ensuring manufacturing processes, documentation, training, and controls are ready for production release.
Coach engineers and operators on working effectively within a regulated QMS and maintaining strong documentation habits.