Job Details

• Lead a team of mechanical engineers and designers to support new product development, product improvements and manufacturing.
• Collaborate with cross-functional stake holders such as marketing, quality assurance, and manufacturing, to ensure alignment on project scope, design control documentation, quality and scheduling.
• Maintain a high level of communications with cross-functional team members and partners.
• Collaborate with internal resources to develop technical solutions to difficult problems that are thorough, practical, and consistent with organization objectives. These are often documented on Corrective Action and Preventive Action (CAPA) reports.
• Lead design control procedures to ensure they meet current regulatory requirements and provide a clear and efficient product design process.
• Establish and modernize the engineering process and tools that are used by the team to optimize engineering performance in the context of business needs
• Monitors documentation maintenance throughout all phases of design.
• Provide training, coaching and mentorship to team members. Drive a culture of creativity, innovation and continuous learning.
• Ensure that all direct reports are familiar with, trained on, and follow all quality system procedures related to their job.
• Selects, develops and evaluates personnel to ensure the efficiency of team.

• Strong organizational and leadership skills
• Experience leading product development from requirements to final release/launch
• Deep knowledge and application of following standards in the work experience – FDA, HC and ISO 13485 Quality System Regulations, Design Controls, Good Manufacturing Practices, ISO 14971, IEC60601
• Proficient in Solid works (Part, Assembly, Sheet Metal & Simulation)
• Strong data analysis skills, and proficient in the use of statistical tools in problem solving.
• Strong computer skills (MS Outlook, Word, Excel & MS Project)
• Possesses strong communication skills (verbal & written)
• Experience or working knowledge in fabrication/machining tools

Reference ID - GH/CRS/JC//31012020//89142/Mechanical Engineering Manager