The Engineering Manager will be responsible for design transfer activities and operational deliverables required for mass production of Patient Monitoring products and technologies. The desired candidate will lead and partner closely with functional group heads (HW, SW, System design) and supporting functions starting from concept stage through prototyping to manufacturing.
Essential Duties and Responsibilities
· Leads the operation engineering efforts, including
· Defining, documenting, and Improving manufacturing process
· Leading Troubleshooting manufacturing issues sessions
· Conducting Root cause analysis of issues and documenting them
· Managing engineering Risk Analysis processes
· Sharing manufacturing needs during the development phase
· Defining manufacturing quality needs and validate impact on manufactured product quality – ATE, Final Tests etc.
· Training the manufacturing teams on processes and standards
· Evaluating/examining and recommending manufacturing technologies
· Own the Product/Production file, , BOM, from design stage till production implementation
· Be responsible for implementing ECO’s and manage product tree
· Set an overall Operational NPI plan,
· Manage prototypes and NPI builds
· Working with and managing subcontractors, in various disciplines , before and during the manufacturing phase
· Recommends changes to policies and establishes procedures that affect immediate department/function and product quality
· Create opportunities to automate processes automate testing and optimize test processes during the manufacturing phase and while defining a new product manufacturing process
· Participate in the system integration planning activities for all product lines. Engage in manufacturing test planning during design and development phases.
· Create best practices and process improvements to product manufacturing process
· Collaborate with third party vendors for the successful completion of Projects
· Ensures compliance of the manufacturing process and standard work requirements.
· Participates and/ or leads design reviews of manufacturing process with R&D teams and 3rd parties
· Develops and maintains an effective and collaborative working relationship with internal and external development partners across all levels and diverse cultures.
· Guides the team in investigations for identifying the root cause and drives action to prevent such issues recurring.
Qualifications
· Independent and a self-starter
· Bachelor’s Degree in mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent, MS preferred, with approximately 8+ years of relevant industry experience with a minimum of 3 years in relevant functional capacity in a regulated product environment
· Experience includes working for a company with a multidisciplinary product(s)- Electronics, Plastics, Software
· Global Healthcare industry experience in a complete product cycle preferred.
· Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel.
· Strong knowledge of ISO, FDA and other relevant regulatory standards is essential.
· Demonstrated experience working with vendors with different models of engagement.
· Creative and resourceful in troubleshooting malfunctions
· Ability to work across multiple tasks and interfaces.
· Excellent verbal and written communication and presentation skills in Hebrew and English.
· In-depth knowledge and experience in transferring from development to production (NPI), experience in the transfer of complex and multidisciplinary products, in the fields of electronics, mechanics and software, from development to manufacturing.