MediView is building the future of surgical guidance and navigation with Augmented Reality (AR) and Artificial Intelligence (AI). The Manufacturing Engineer will serve as manufacturing liaison and coordinate all sustaining engineering activities into the manufacturing cycle and production of products. This role will also be responsible for executing the end-to-end sourcing and purchasing processes including ERP and Inventory management. Evaluates, selects, and applies Manufacturing Engineering techniques to develop economical and efficient methods to develop work instructions and satisfy production needs. Assists with production to meet production schedules and provides necessary input to develop manufacturing specifications for manufacturing operations/workstations, including incoming inspection. Recommends and works with product teams to implement design changes to improve reliability, manufacturability, and cost. This position also handles the preparation and maintenance of required records of production activities and reporting any inconsistencies or equipment issues while following established guidelines for safe material handling and protective gear.

DUTIES AND RESPONSIBILITIES:

• Ensure manufacturing production needs and requirements support overall business plan.
• Function as primary manufacturing representative for production output.
• Ensure the highest standards of quality with manufacturing processes.
• Work with quality to manage RMA process for supplier returns.
• Ensure system assembly and quality production through all phases from Raw material to finished goods.
• Review and help generate product documentation pertaining to engineering drawings and work instructions, including initial release and subsequent revisions.
• Recommend tooling, test equipment, and facility requirements.
• Assist with manufacturing plans for prototype, pre-production, and production.
• Develop clear and concise manufacturing specifications/instructions to maintain quality and to assure smooth workflow.
• Develop workmanship standards to accommodate manufacturing/inspection and assure conformance to specifications.
• Assist in development of standard cost estimates and Bill of Material standard cost.
• Assure manufacturing tooling and test equipment are available to meet production requirements.
• Perform manufacturing studies leading to recommendations for new and improved methods, procedures, and equipment utilization.
• Initiate and execute supply chain procurement/sourcing plans that support business objectives and maximize profitability through lower costs, rebates, volume discounts, or revenue generation opportunities.
• Works collaboratively with internal business partners (Accounting, Quality, Regulatory, Operations and Development Engineering), as required to continually improve the sourcing process.
• Updates daily, weekly, and monthly reports; including but not limited to Inventory Balances, Manufacturing Order Fulfillment, On Time Delivery, and anticipated deliveries.
• Participates in supplier assessments and/or visits to evaluate performance and maintain constructive business relationships.
• Work with both domestic and international suppliers to achieve scheduled promise dates.
• Ensures purchasing budget limits are followed and keeps track of all cost variances to ensure adherence to MediView policies and procedures.
• Follows environmental and safety regulations and acts in compliance with U.S. laws and Trade Compliance.
• Comply with safety and corporate guidelines on business ethics.
• Ensure accuracy of item information; including but not limited to cost, lead-time, MOQ, and revision level.
• Ability to work cross-functionally in a team environment.
• Ability to work flexible hours.
• Ability to work in a regulated environment (FDA, ISO, OSHA).
• Assist with the training of new team members, including cross-training of existing team members.
• Perform all other duties as assigned.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Education and/or Experience – Bachelor’s degree in engineering preferred. Must be technically knowledgeable of Good Manufacturing Practices relating to machines, metal forming, metal joining, assembly. Experience working in engineering and/or medical device equipment manufacturing. ERP/MRP experience prefferred (AS4000, SAP, Oracle, Microsoft Dynamics, NetSuite, etc.). Understanding of LEAN manufacturing. APICS certification is a plus.
• Language Skills – Strong communication skills such as written, verbal as well as customer service skills. Ability to effectively present information to management, public groups, and/or board of directors. Ability to interact clearly and effectively, in both written and oral communication, with supervisor, clients, staff, suppliers, etc.
• Computer Skills - Computer Skills – To perform this job successfully, an individual should be proficient in personal computer skills including experience with Pro-Engineer (Pro-E), AutoCAD, and PDM/PLM. Knowledge of MRP/ERP is also preferred. This role requires an above-average knowledge of Microsoft Office with advanced proficiency with Excel formulas. Knowledge of MS Project is a plus.
• Other Qualifications - Valid driver’s license is required; Must be able to travel 20-30% of the time; Overnight stays may be necessary. Experience and ability to work in a fast-paced, tech startup environment where change is a constant and roles and tasks can be ambiguous at times.

PHYSICAL DEMANDS:

Position requires sitting, standing, lifting, carrying, walking, reaching, stooping, kneeling, climbing, pulling, and pushing. May be required to move and/or carry/lift up to a maximum of fifty (50) pounds. May be required to use material handling equipment. Frequent use of computer and telephone. May be required to travel (domestic and international). Hours of work may exceed normal business hours at times.

WORK ENVIRONMENT:

While performing the duties of this job, the individual is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually low to moderate. The individual frequently works in a controlled climate. May be in clinical or hospital environments where health may be at risk due to exposure from patients that may have infectious diseases.