Reports To: QA Manager

Job Requirements & Responsibilities

• Support and manage core quality activities, including Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), Complaints, and Change Control (ECO).
• Assist in the performance and preparation of both internal and external quality audits.
• Coordinate and follow up on employee training, qualification, and competency activities to ensure organizational compliance.
• Support the qualification and ongoing evaluation of suppliers.
• Support the production activities (Review Device History Records (DHRs) and quality documentation for completeness and batch release).
• Participation in Design Reviews and verification of execution of Action Items related to quality issues.
• Provide quality support for V&V processes, including software validation, equipment validation, and the review of engineering documents.
• Administer controlled documents and maintain quality records.

EDUCATION and EXPERIENCE

• Bachelor’s degree in science or mechanical / (bio-)medical engineering.
• At least 3 years’ experience in quality assurance in medical device.
• Experience with medical devices that integrate both Hardware and Software
• Strong familiarity with ISO standards and regulatory requirements (e.g., ISO 13485 or 21 CFR 820).
• Good communication and teamwork skills.
• Good technical understanding.
• Proficient in English (reading, writing, speaking)

Reports to: Operations Manager

Role Summary

BRAIN.Q is seeking an Engineering Manager to lead the transition of its medical devices from R&D into scalable, compliant, and cost-effective production. This role owns the Design Transfer process, drives validation and qualification efforts, maintains the engineering and manufacturing BOMs, and provides hands-on support to production. The Engineering Manager will collaborate closely with Operations, Quality, and R&D to ensure manufacturability, robustness, and readiness for global scale.

The ideal candidate has deep hands-on engineering experience in medical devices, strong knowledge of manufacturing processes, and thrives in fast-paced, cross-functional environments.

Key Responsibilities

Design Transfer & Industrialisation

• Lead the engineering transfer of products from R&D to production, ensuring designs are manufacturable, testable, and cost-effective.
• Translate design requirements and specifications into robust, repeatable manufacturing processes and work instructions.
• Own and maintain the Design Transfer documentation according to company procedures and regulatory requirements.

BOM (Bill of Materials) Ownership

• Own the engineering BOM (eBOM) and production BOM (mBOM) for all products.
  Ensure BOM accuracy, structure, and version control across engineering and operations systems (e.g., ERP/PLM).
• Implement cost-reduction opportunities and alternative components in collaboration with Operations, Quality, and R&D.

Validation & Qualification

• Plan and execute process and equipment qualification and validation activities (e.g., IQ/OQ/PQ) for production lines, tools, and test equipment.
• Define and approve test methods, inspection plans, and acceptance criteria for critical components and assemblies.
• Lead engineering investigations and root cause analysis for nonconformities, process deviations, and field issues.
  

Production Support

• Provide day-to-day engineering support to production lines to ensure yield, quality, and on-time delivery targets.
• Define and optimize assembly methods, test procedures, jigs, and fixtures.
• Monitor key production KPIs and drive continuous improvement projects (quality, throughput, cost, scrap, rework).
  

Sourcing & Supplier Engagement

• Work with Operations, Purchasing, and Quality to identify, evaluate, and qualify suppliers for mechanical, electronic, and custom components.
• Provide technical input to supplier selection, audits, and performance reviews.
• Support DFM (Design for Manufacturing) and DfS (Design for Serviceability) discussions with suppliers and contract manufacturers.
  

Documentation & Compliance

• Ensure all engineering and production documentation is complete, up to date, and compliant with relevant standards (e.g., ISO 13485, 21 CFR 820, IEC/UL standards, as applicable).
  Participate in risk management activities (e.g., FMEA) related to design transfer, new processes, and changes in materials or suppliers.
• Support internal and external audits with technical and process documentation.
  

Cross-Functional Collaboration

• Work closely with R&D to influence design decisions based on manufacturability, reliability, and lifecycle considerations.
• Collaborate with Quality Assurance, Regulatory Affairs, Supply Chain, and Service to ensure integrated design and operational readiness.
  Provide engineering input for product changes, ECOs (Engineering Change Orders), and post-market improvements.

Qualifications

Must-Have

• Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related discipline.
• 5+ years of engineering experience in the medical device or regulated industry.
• Hands-on experience with design transfer, NPI, or production engineering.
• Strong familiarity with electro-mechanical manufacturing processes (PCBA, assembly, testing).
• Experience with IQ/OQ/PQ and test method validation.
• Strong BOM management and document control experience (ERP/PLM).
• Knowledge of ISO 13485, 21 CFR 820, and ISO 14971.
• Excellent problem-solving and data-driven decision-making skills.
• Strong communication skills and ability to collaborate with R&D, Operations, Quality, and suppliers.
• Familiarity with IEC 60601 or relevant electrical device standards (if applicable)
  

Nice-to-Have

• Experience working with contract manufacturers and global suppliers.
• Experience in designing and validating jigs, fixtures, and test equipment.
• Experience in cost-reduction initiatives and value engineering.
• Previous leadership or mentoring experience of engineers/technicians.

Personal Attributes

• Strong sense of ownership and accountability for quality and on-time delivery.
• Detail-oriented, organised, and comfortable working with controlled documentation.
• Hands-on, collaborative, and willing to spend time on the production floor.
• Continuous improvement mindset focused on robustness, scalability, and efficiency.