Overview

The Manufacturing Engineer primarily plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure aquality product is produced in a timely manner, in addition to performing sustaining activities for commercially available products The Manufacturing Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, and improve quality while ensuring products and processes meet regulatory compliance.

Responsibilities

• 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 productdevelopment 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.

Qualifications

• 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

Physical Requirements:

• 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.