Engineer II, Production (Merrimack, NH)

Getinge•Merrimack, NH

2d•$75,000 - $100,000•Onsite

About The Position

Supports the commercialized production of medical devices. Works within manufacturing engineering functions to provide technical support for the quality of the product, process development, continuous improvement, and process control.

Requirements

Bachelor’s Degree in Engineering, or equivalent work experience.
Three years related manufacturing experience (medical device field is preferred).
Must be highly skilled in equipment troubleshooting (Electro-mechanical)
Must possess good problem solving skills and data analysis skillset.
Demonstrated knowledge of MS Office applications (Word/Excel/PPT) is required (Minitab experience is preferred).

Nice To Haves

Experience working with FDA requirements preferred.
Experience working within a medical manufacturing environment preferred.
Working knowledge of statistical process control and lean manufacturing preferred.
Working knowledge of computer aided drawings (CAD / solid works) preferred.

Responsibilities

Works in team setting and works independently with minimal oversight.
Supports production / manufacturing.
Supports / Leads scrap reduction / equipment downtime reduction, and Lean efforts.
Developed manufacturing methods into work instructions and associated training for transfer into production.
Develops required maintenance and calibration instructions for manufacturing equipment and creates required equipment documentation.
Provides higher level assistance for equipment design for producing medical devices and components.
Perform process development and validation including IQ, OQ, PQ, EAT, & TMV.
Perform process improvement initiatives.
Supports / Leads non-conformance investigations, CAPA activity, OOT’s, Customer complaints, PFMECA’s, MES, and equipment troubleshooting.
Executes complex change orders (ECO’s) related to process and equipment documentation.
Analyzes and documents test results for development and pilot production runs.
Generates and manages PSO’s.
Specifies and executes equipment and tooling verifications and equipment acceptance tests.
Contributes to the team effort by accomplishing related tasks as necessary.
Support business metrics.
Participate / Lead large scale projects.
Protocol and report writing.
Identify, Lead, and Resolve component / supplier related problems.
Perform other related duties as required.
Performs data analysis / root cause investigations with data driven approach.