Product Development Engineer II

POSITION SUMMARY 

Supports assigned customers to assure best in class design and quality for product and provides seamless communication between Meraqi and customers. 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

• Design and develop class III implantable devices 

• Ensure designs meet performance specifications, regulatory and manufacturing requirements 

• Manage product development projects.  

• Prepare, track, and communicate project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs. Coordinate tasks and schedule. 

• Use software to develop detailed 3-D CAD models and drawings  

• Interact with customers in a professional manner. Proactively communicate with customers to ensure an ongoing two-way exchange of information.  

• Maintain Design History Files. 

• Assemble and/or evaluate prototype devices.  

• Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.  

• Working with all internal groups, identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements. 

• Promptly respond to product issues, taking appropriate action within the Meraqi Quality System and continually building strong rapport with customers and suppliers. 

• Collaborate with all departments to develop optimal work order routings and Device History Records. 

• Lead the generation of redlined documentation and review prior to sign off. 

• Lead and oversee the training of Assemblers/Technicians/Inspectors as needed. 

• Oversee the generation of process validation/qualification documentation (e.g., validation protocols, IQ/OQ/PQ) and lead the implementation of protocols and completion of reports. 

• Lead customer specific team meetings. 

• Perform other activities as directed. 

• Complete accurate daily time card 

SUPERVISORY RESPONSIBILITY 

None 

REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE 

• Bachelor’s degree in engineering is desired 

• 3 years of medical device product design and development experience or equivalent is preferred, catheter experience desired 

• Demonstrated ability to bring products from concept to market 

• Ability to interact with client companies in a professional manner 

• Familiarity with FDA, QSR, and ISO 13485 medical device regulations and standards 

• Depth of knowledge in one or more clinical areas 

• Depth of knowledge in one or more product areas 

• Depth of knowledge in one or more technical areas (ie sterilization) 

• Flexibility, persistence, passion, resourcefulness, a drive to succeed, and an entrepreneurial spirit 

CORE COMPETENCIES 

Communication Skills 

All verbal and written communications are concise, technically accurate, timely, and professional.  Demonstrates strong verbal presentation and negotiation skills. Represents in a positive and professional manner.  Expresses ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrates tact and diplomacy in communications. Demonstrates active listening skills and ability to resolve discrepancies with customers  

Management of Resources 

Well organized and uses time efficiently. Familiar with all reference materials and can locate needed information as necessary.  Takes initiative for self-development. Prioritizes tasks effectively. Demonstrates initiative and creativity in the use of available resources. 

Customer Focus 

Provide professional, reliable and prompt service to internal and external customers Work in partnership with others to meet and exceed customer expectations. Interpret customer needs and take appropriate action. Follow through on customer inquiries in a professional and timely manner. 

WORKING CONDITIONS / PHYSICAL DEMANDS 

Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery, and tools.  May lift up to 30 pounds and stand for extended periods of time. Must tolerate exposure to chemicals found in the Meraqi Medical Inc environment 

The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required. 

External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.