Engineering Manager

Responsibilities

• Managing design transfer processes from design freeze to implementation of stable and validated production line
• Manages the day-to-day activities of the engineering team as well as the management and execution of team’s projects against delivery commitments and project plans/goals
• Provides technical guidance and direction, as well as hands-on resource and project management, for all engineering activities.
• Managing Device Master Records (DMR) and Engineering Change processes - (ECO/R).
• Preparing Product Specifications and technical documentation.
• Organize manufacturing validation activities for new and existing products, in order to ensure product specifications and standards are achieved.
• Troubleshooting manufacturing problems (NCR/MRB), investigating production failures and finding root cause.
• Laboratory work, including equipment/ fixtures (Jigs) purchasing, calibration and maintenance.
• Collaborates with other business departments, working with external factors (suppliers and subcontractors) and internal bodies (R&D, regulation, quality, finance, marketing, operation, process and manufacturing).
• Determining the requirements for manufacturing subcontractors and monitoring activities of relevant subcontractors.
• Supporting Quality and production departments as needed.
• Ability to clearly communicate and lead discussions around strategy and engineering principles
• Proactively manages costs, risk and opportunities for operational excellence

Professional Requirements:

Education & Experience:

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 5+ years of experience in medical device engineering, manufacturing, and NPI, with at least 2 years in a leadership role.
• Extensive experience in design transfer, process validation, and sustaining engineering within a regulated manufacturing environment.

Technical & Industry Expertise:

• Deep understanding of medical device manufacturing processes, including cleanroom operations, sterilization, and material compatibility.
• Excellent understanding with the following: complex machined parts, plastics injections, cable assemblies, PCBA
• Strong knowledge of design for manufacturability (DFM) and design for assembly (DFA) principles.
• Hands-on experience with process validation (IQ, OQ, PQ), equipment qualification, and statistical process control (SPC).
• Experience in ERP system, PLM, agile and Priority

Regulatory & Compliance Expertise:

• Expertise in medical device regulations and quality systems including compliance with cleanroom standards, sterilization and biocompatibility.
• Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and process control standards.

Leadership & Cross-Functional Collaboration:

• Experience working closely with R&D, quality assurance, regulatory affairs, supply chain, and contract manufacturers to ensure a smooth product transition from development to production.
• Track record of mentoring and developing high-performing teams while driving a culture of operational excellence.

Communication & Documentation:

• Strong experience in authoring and reviewing technical documentation, including DHF (Design History File), DMR (Device Master Record), validation protocols, and manufacturing work instructions.
• Ability to communicate effectively with executives, regulatory agencies, and cross-functional teams.

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