The Manager of Engineering is responsible for ensuring that key projects and engineering duties are fulfilled. He/She leads a team to manage product sustaining engineering function that is responsible for obsolescence, field and manufacturing issues. A few of the main duties of the manager of Engineering are; answering technical questions, proposing budgets for projects, hiring and training new employees, and working seamlessly with other departments (Manufacturing, Materials, Regulatory, Quality, and Finance, etc. ). Prepare reports and deliver presentations on the progress of any project to senior management. He/She and his/her team are the technical expert in the product use, its repair, maintenance, and troubleshooting.
Responsibilities:
· Responsible for building the US based teams including mechanical, electrical, firmware, and software) engineering group; including resource planning, hiring, and managing engineers, designers, and technicians, to support technical roadmap, along with corporate technical goals and objectives. Mentor and develop talent to allow for individual career growth and organizational mobility.
· Conduct regular department and one-on-one meetings with staff to resolve issues, maintain engagement/focus, and share updates on project and activities.
· Own, staff and equip the engineering lab spaces with state-of-the-art equipment, tools, and processes, while maintaining a safe, compliant, and efficient lab environment.
· Provide the organization with technical expertise in the use and improvement of orthopedic robots and act as in-house industry expert in orthopedic robotic surgery.
· Support on-going operations with technical expertise, working cross-functionally on design changes for improved manufacturing yields and throughput, cost reductions, quality improvements and actively managing EOL (End of Life) and part obsolescence issues.
· Coordinate with leadership colleagues across various functions to foresee/understand critical project activities and to enable them to manage team resources and tasks to maintain critical path
· Responsible for external collaboration; evaluation of technology; research integration between the industry and universities and other related technical strategic cooperation matters; to recommend products and technical layouts in line with the company’s overall strategy
Qualifications and Skills:
· An advanced degree (M.S.) in Mechanical/Electrical/Biomedical Engineering or equivalent required.
· Minimum of 5 years of Engineering Management in the Medical Device industry with a proven track record of technical team building with multiple direct reports required. Familiarity with robotic or complex Medical Devices; strong technical decision-making ability; project and risk management and control capabilities
· Working knowledge of core engineering tools. For example: 6-sigma, Failure Mode Effects & Analysis (FMEA), Risk Analysis, Process Mapping, Standard Work Instructions, Lean Manufacturing, Manufacturing Work Instruction Creation, Design of Experiments (DOE) methods, Process Characterization, Verification & Validation activities
· Working knowledge of 21 CR 820, ISO 13485, and ISO 14971
· Strong leadership and communication skills, with the ability to communicate effectively from the board room to the manufacturing floor
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