Manager, Manufacturing Engineer (781072)

Job Overview

Job Description

Job Description:

Support the day-to-day activities of the Operations and Manufacturing Engineering Group. Own the key automation equipment used to produce lnsulet products. Responsible for KPls for machine up time, process yield and efficiency for his/her group of automation equipment, in addition to managing and executing other manufacturing projects. Projects may include cost and quality improvements, line qualifications and new product introductions (NPI). As part of providing support to the Operations and Manufacturing Group, carry out root cause investigations using structured problem-solving tools and will author and review quality system documentation such as validations, work instructions, SOPs, non conforming material investigations, and tool files. Responsible for performance and sustainability of automation equipment, and all reporting / performance tracking requirements for their respective Cells. Drive product and process improvements in support of lnsulet's Operations (4) main objectives: best quality; highest efficiency; highest customer service; and lowest cost. Develop and drive Continuous improvement efforts. Manage lnsulet Automation suppliers and deliver new machines and machine improvements. Maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing. Generate validation/qualification protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports. Author and implement Engineering Change Orders. Design and coordinate the construction and validation of manufacturing fixtures. Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support. Use standardized root cause investigation templates and problem-solving tools to carry out non-conforming material investigations. Implement corrective and preventive actions. Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPls are at or above target. Support new product introduction initiatives. Travel to key suppliers to help them carry out critical investigations or improvement projects. Carry out duties in a quality system environment. Possess strong mechanical analysis skills. Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics. Interpret the mechanical properties of the selected material for the product design and make recommendations for suitable alternatives. Up to 25% international travel for equipment development, procurement, and in support of overseas manufacturing.

40 hours/week, 9:00am-5:00pm
Job Requirements:

Requires a Bachelor's degree (or foreign equivalent) in Mechanical Engineering, Industrial Engineering, Engineering Management, or a directly related discipline plus seven (7) years of experience as a Manufacturing Engineering or similar occupation. Experience must include:

Four (4) years of experience in each of the following (experience may be gained concurrently):

- Experience in the medical device industry or similarly regulated field

- Experience using Microsoft standard software (Word, Excel, and PowerPoint)

Three (3) years of experience in each of the following (experience may be gained concurrently):

- Troubleshooting mechanical equipment both semi and fully automated

- Experience with common challenges with assembly of molded components

- Using structured problem solving tools, DMAIC, POCA, or 8D

- Working in semi or full automated manufacturing environment

- Performing verification and validation of equipment, including IQ/OQ/PQ, or TMV

Two (2) years of experience in each of the following (experience may be gained concurrently):

- Data Analysis Skills using Minitab or JMP

- Experience using Solidworks for design and drafting

One (1) year of experience in each of the following (experience may be gained concurrently):

- Identifying equipment problem areas and proposing solutions

- Performing equipment upgrades and necessary process development work

Will accept a Master’s degree (or foreign equivalent) plus four (4) years of experience as Manufacturing Engineering or similar occupation in lieu of a Bachelor’s degree plus seven (7) years of experience.
Please copy and paste your resume in the email body (do not send attachments, we cannot open them) and email it to candidates at placementservicesusa.com with reference #781072 in the subject line.

Thank you.