The Production Engineer at Cook Vandergrift Inc. plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner. The Production Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality.
• Lead or assist in CAPA investigations and implementations
• Develop, maintain, improve manufacturing and inspection processes and procedures
• Perform equipment and process validations and testing to internal procedures and/or external standards
• Develop cleanliness and environmental control processes and procedures
• Define equipment maintenance requirements
• Design and improve manufacturing and inspection equipment
• Assist with training manufacturing and QC operators
• Assist with equipment and instrument calibrations
• Assist with procurement
• Assist with resolving issues with suppliers
• Assist with repairing equipment and tooling
• Assist with performing process failure mode effects analyses
• Work with Operations Managers and outside Vendors to create methods/machines to help with capacity of products
• Work with Product Development Engineers to develop processes for new products
• Work with Operations, Accounting, and Global Product Managers to increase profit margins of current products which do not meet company requirements
• Train all relevant personnel on new processes
• Document cost savings
• Assure projects follow design controls established by QSPs
• Work with management to establish project timeliness, project justification, and budget forecasts
• Act as resource for operational departments for materials, equipment and process upgrades
• Work to transfer intra-Cook company products into operations
• Must demonstrate responsibility for the quality and financial aspects of the company
• Will actively learn and update skills needed to perform tasks using all software mandated by the corporation
• Will actively learn and update skills needed to keep up to date on all product development projects assigned and will seek assistance if needed to solve assigned problems
• Responsible for compliance to the company's Quality Policy Manual & Procedures.
• Responsible for compliance to the company's safety policies.
• Must maintain a positive and professional representation of the company in the field.
• Must maintain confidential access to the company's new and / or existing product
designs and plans.
• Bachelor’s Degree in Mechanical, Electrical, Production, or Manufacturing Engineering, or related field; or experience of such kind and amount as to provide a comparable background
• Must be able to work alone and on teams with good interpersonal and leadership qualities to get assigned tasks completed in a timely manner
• Must possess effective and pertinent written and verbal communications skills.
• Must possess good organizational and prioritization skills in order to maintain and
address multiple assigned projects and expectations.
• Must be able to focus on all details and requirements of current medical device
• Ability to get along with others
• Good visual acuity
• Good manual dexterity
• Ability, on occasion, to lift a minimum of 30 pounds
• Limited exposure to hazardous chemicals and material
• Majority of day spent in clean, climate controlled lab requiring the use of safety glasses