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.