Manufacturing Engineer 2

The Production Engineer 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/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, procurement, resolving issues with suppliers.
• Assist with equipment instrument calibrations, performing process failure mode effects analyses and repairing equipment and tooling.
• 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.
• Must maintain a positive and professional representation of the company.

• 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/ 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/ update skills needed to keep up to date on all product development projects assigned and seek assistance if needed to solve problems.
• Must maintain confidential access to the company's new and/or existing product design and plans.
• Responsible for compliance to company's Quality Policy Manual.
• Responsible for compliance to company's safety policies.

• 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.
• Ability to get along with others.

• 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 product development