Manufacturing Engineer II

Getinge•Merrimack, NH

10d

About The Position

The Manufacturing Engineer II supports commercialized medical-device production by providing technical support for product quality, process development, continuous improvement, and process control. The role works both independently with minimal oversight and as part of a team, supporting production and manufacturing operations. It develops manufacturing methods, work instructions, training, maintenance and calibration instructions, and equipment documentation. It also provides higher-level assistance with equipment design and performs process development, validation, improvement, troubleshooting, data analysis, and root-cause investigations. The position supports or leads scrap and downtime reduction, Lean efforts, non-conformance investigations, CAPA activity, out-of-tolerance events, customer complaints, PFMECA, MES, large-scale projects, and supplier-related problem resolution. It executes complex process and equipment change orders, analyzes test results for development and pilot production runs, manages PSOs, and specifies and executes equipment and tooling verifications and acceptance tests. Work is primarily in an office or workshop, with frequent tasks in ISO Class 8, 7, and 5 cleanrooms. Gowning and work in controlled environments are required. Occasional lifting of items under 50 pounds and light assembly may be required. Travel is typically not required but may occur.

Requirements

Bachelor’s degree in Engineering or equivalent work experience.
Three years of related manufacturing experience.
High skill in electro-mechanical equipment troubleshooting.
Good problem-solving skills and data-analysis skills.
Demonstrated knowledge of MS Office applications, including Word, Excel, and PowerPoint.
Knowledge and understanding of Quality Assurance methods.
Ability to organize, prioritize, and adapt.
Ability to multitask in a fast-paced environment.
Excellent oral and written communication skills.
Able to gown up and perform tasks in a controlled cleanroom environment.
Occasional lifting of items under 50 pounds and light assembly work may be required.

Nice To Haves

Medical-device manufacturing experience.
Minitab experience.
Experience working with FDA requirements.
Experience in a medical manufacturing environment.
Working knowledge of statistical process control and Lean manufacturing.
Working knowledge of computer-aided drawings, CAD, or SolidWorks.

Responsibilities

Support production and manufacturing.
Support or lead scrap reduction, equipment downtime reduction, and Lean efforts.
Develop manufacturing methods into work instructions and associated training for transfer into production.
Develop maintenance and calibration instructions for manufacturing equipment and create equipment documentation.
Provide higher-level assistance with equipment design for producing medical devices and components.
Perform process development and validation, including IQ, OQ, PQ, EAT, and TMV.
Perform process improvement initiatives.
Support or lead non-conformance investigations, CAPA activity, OOTs, customer complaints, PFMECA, MES, and equipment troubleshooting.
Execute complex change orders related to process and equipment documentation.
Analyze and document test results for development and pilot production runs.
Generate and manage PSOs.
Specify and execute equipment and tooling verifications and equipment acceptance tests.
Support business metrics and participate in or lead large-scale projects.
Write protocols and reports.
Identify, lead, and resolve component- and supplier-related problems.
Perform other related duties as required.
Perform data analysis and root-cause investigations using a data-driven approach.
Contribute to team efforts by accomplishing related tasks as necessary.