Job Description:
Madison Scientific is redefining the treatment of hydrocephalus. Our Smart Shunt system combines implantable hardware, wearable technology, and cloud intelligence. We are looking for a Manufacturing & Quality Engineer.
What You’ll Do:- Support implementation and day-to-day operation of the company's Quality Management System (QMS) in accordance with ISO 13485 and applicable regulatory requirements.
- Administer and maintain the electronic Quality Management System (eQMS), including document control, training, change management, and quality records.
- Support design control activities, including design reviews, requirements traceability, risk management, verification and validation, engineering changes, and maintenance of the Design History File (DHF) and Device Master Record (DMR).
- Support creation, review, revision, and release of controlled procedures, work instructions, specifications, forms, and other quality and product documentation.
- Support development, execution, and documentation of verification and validation activities, including test protocols, test records, equipment readiness, and documentation review.
- Support transfer of product designs and manufacturing documentation to contract manufacturers and suppliers.
- Work with contract manufacturers to ensure manufacturing processes, work instructions, inspection methods, and production documentation are appropriately established, reviewed, and controlled.
- Support prototype, verification, clinical, and low-volume production builds, including coordination with contract manufacturers and resolution of build-related issues.
- Support and oversee qualification and validation of manufacturing processes and equipment performed internally or by contract manufacturers.
- Support incoming inspection, acceptance criteria, supplier quality controls, and other manufacturing quality activities appropriate to component and product risk.
- Support supplier and contract manufacturer qualification, audits, performance monitoring, and ongoing quality oversight.
- Participate in investigation of nonconformances, supplier issues, manufacturing problems, CAPAs, and root causes, and support implementation of appropriate corrective actions.
- Participate in design reviews and provide quality and manufacturing input to support manufacturability, design transfer, and production readiness.
- Support clinical trial activities related to investigational device readiness, including clinical device builds, device release documentation, labeling, traceability and accountability, site training documentation, and investigation of device-related issues.
- Assist with preparation for internal audits, supplier audits, external audits, and regulatory inspections.
- Collaborate closely with hardware, software, regulatory, clinical, operations, suppliers, and contract manufacturers as the company progresses from product development through clinical studies and commercialization.
Required Qualifications:- Bachelor's degree in Engineering, Biomedical Engineering, Quality Engineering, or another related technical field.
- 3+ years of experience working within a regulated medical device environment.
- Working knowledge of ISO 13485, medical device design controls, document control, change control, and regulated product development processes.
- Experience supporting design control, verification and validation, engineering changes, and maintenance of controlled product documentation.
- Experience supporting manufacturing, supplier quality, design transfer, or production activities for medical devices or other regulated products.
- Experience investigating quality, manufacturing, or supplier issues using structured root-cause analysis.
- Experience working with controlled documentation and quality records within an eQMS environment.
- Ability to work independently while collaborating effectively with engineering, operations, regulatory, clinical, suppliers, and contract manufacturers.
- Strong organizational skills, attention to detail, and written and verbal communication skills.
Preferred Qualifications:- Experience working in a medical device startup or early-stage company.
- Experience supporting implementation or maintenance of an ISO 13485-certified Quality Management System.
- Experience supporting design controls for electromechanical, implantable, or software-enabled medical devices.
- Experience with medical device design transfer, contract manufacturing, supplier qualification, or low-volume production.
- Familiarity with process validation, equipment qualification, and manufacturing process controls.
- Knowledge of risk management processes such as ISO 14971 and FMEA methodologies.
- Familiarity with software development documentation and IEC 62304 processes.
- Experience supporting investigational device builds or clinical trials.
- Experience supporting CAPA, nonconformance management, internal audits, and supplier audits.
