Engineering and Production Manager

Location:

Jerusalem/Modiin

Role Summary

BRAIN.Q is seeking an Engineering & Production Manager to lead the transition of its medical devices from R&D into scalable, compliant, and cost-effective production, while providing direct oversight of daily manufacturing operations. This role owns the Design Transfer process, manages the production team and floor activities, drives validation and qualification efforts, and maintains the engineering and manufacturing BOMs. The Engineering & Production Manager will collaborate closely with Operations, Quality, and R&D to ensure manufacturability, operational efficiency, and readiness for global scale.

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

Key Responsibilities

Production Oversight & Management Lead, mentor, and manage the production team, including assembly operators and manufacturing technicians. Oversee daily production schedules and resource allocation to ensure production volume, yield, and on-time delivery targets are met. Ensure the shop floor operates safely, efficiently, and in strict adherence to company quality procedures and regulatory standards. Establish, monitor, and report on key production KPIs (e.g., throughput, yield, scrap, OEE, and unit cost), driving continuous improvement and Lean manufacturing initiatives.

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 & Engineering Support Plan and execute process and equipment qualification and validation activities (e.g., IQ/OQ/PQ) for production lines, tools, and test equipment. Define and optimize assembly methods, test procedures, jigs, and fixtures. 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.

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, with at least 2 years in a production management or supervisory role. Hands-on experience with design transfer, NPI, and running a manufacturing floor. 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, data-driven decision-making, and people management 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 implementing Lean Manufacturing or Six Sigma methodologies on the production floor. 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.

Personal Attributes

Strong sense of ownership and accountability for team safety, product quality, and on-time delivery. Detail-oriented, organised, and comfortable working with controlled documentation. Hands-on, collaborative, and highly visible on the production floor. Continuous improvement mindset focused on robustness, scalability, and efficiency.

Apply at : https://wkf.ms/3KnDO31