Senior Manufacturing Quality Engineer

• Location: Cambridge, MA

• Department: Quality Assurance

• Reports To: Director of Quality Assurance

Summary

Axoft is building the most advanced infrastructure for implantable brain-machine interfaces. Our mission is to enable long-term stable and ultra-high bandwidth communication with the brain, opening new therapies and treatments against neurological disorders and physical disabilities. We have bridged the gap between electronic and biological materials to create the softest, nanofabricated brain implants in the world.

Position Overview

Axoft is seeking a Senior Manufacturing Quality Engineer to support the scale-up of regulated manufacturingfor 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.

Key Responsibilities

Manufacturing Quality & Compliance

• 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.

Process Validation, Equipment Qualification & Process Control

• 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.

Production Systems, Documentation & Material Quality

• 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.

Design Transfer & Cross-Functional Collaboration

• 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.

Qualifications

Education

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, or related field) or equivalent technical discipline.

Experience

• 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.

• 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.

Skills

• 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.

What we offer

• An opportunity to work with a team of experts on one of the most exciting problems in the world and change lives.

• Career growth opportunities that fit your potential.

• Comprehensive benefits plan including health and dental insurance; parental leave.

• Flexible paid time off.

Axoft’s ideal team members are people who seek fast-paced, evolving work with bright, thoughtful, and dedicated teammates. We seek and embrace challenges, and we are ultimately focused on improving the health and well-being of people. We believe in producing the highest quality work, and we hold ourselves and each other to high standards of integrity, accountability, growth, and trust.

Axoft provides equal opportunity in all our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.