Medical Device Manufacturing & Quality Engineer

Madison Scientific Inc.; Chicago (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Madison Scientific Inc. is developing a Smart Shunt system combining implantable hardware, wearable tech, and cloud intelligence.

We seek a Manufacturing & Quality Engineer to drive ISO 13485 QMS implementation, document control, and design transfer activities for regulated medical devices in a startup environment. You will support V&V, DHF/DMR maintenance, supplier qualification, and process validation while coordinating with contract manufacturers to ensure production readiness and quality

Qualifications

• Experience in a regulated medical device environment is required.
• Experience with ISO 13485, design controls, document control, and regulated product development processes.
• Experience supporting design control, verification/validation, engineering changes, and documentation.
• Experience in manufacturing, supplier quality, design transfer, or production activities for medical devices.
• Experience investigating quality, manufacturing, or supplier issues using root-cause analysis.
• Experience with controlled documentation and quality records in an eQMS.

Responsibilities

• Support implementation and day-to-day operation of the QMS per ISO 13485 and regulatory requirements.
• Administer and maintain the eQMS, including document control, training, change management, and quality records.
• Support design control activities, including reviews, traceability, risk management, V&V, DHF/DMR.
• Assist creation, review, revision, and release of controlled procedures and forms.
• Support verification/validation activities, including test protocols and reviews.
• Coordinate transfer of designs and manufacturing docs to contract manufacturers and suppliers.
• Work with contract manufacturers to establish and control processes, work instructions, and production docs.
• Support prototype, verification, clinical, and low-volume production builds with contract manufacturers.
• Oversee qualification/validation of manufacturing processes and equipment (internal or contract).
• Support incoming inspection, acceptance criteria, supplier quality controls, and other manufacturing quality activities.
• Assist supplier and contract manufacturer qualification, audits, and CAPA efforts.
• Participate in investigations of nonconformances and root causes with corrective actions.
• Contribute to design reviews and manufacturability assessments for transfer to production.
• Support clinical trial activities related to investigational device readiness and device release docs.
• Prepare for internal/auditor/regulatory inspections with cross-functional teams.
• Collaborate with hardware, software, regulatory, clinical, operations, suppliers, and contract manufacturers throughout development to commercialization.

Skills

QMS experience

ISO 13485 knowledge

Root cause analysis

Document control

Design transfer

Regulatory compliance

CAPA handling

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

eQMS software

Job description

Madison Scientific Inc. is developing a Smart Shunt system combining implantable hardware, wearable tech, and cloud intelligence.

We seek a Manufacturing & Quality Engineer to drive ISO 13485 QMS implementation, document control, and design transfer activities for regulated medical devices in a startup environment. You will support V&V, DHF/DMR maintenance, supplier qualification, and process validation while coordinating with contract manufacturers to ensure production readiness and quality