Manufacturing Engineer (Chelmsford, MA)
Our client, a global provider of clinically effective medical technologies, is currently hiring a Manufacturing Engineer at their site in Chelmsford. Chelmsford is a very high-mix, high-volume site, all of clients' five major products are assembled there- this role is a new position, new January 2024 opened due to growth. The Manufacturing Engineer will join a well-balanced, fun, lively team as an addition to staff to work on continuous improvement projects.
Position Summary:
The Manufacturing Engineer III will have capability within engineering disciplines to support Manufacturing and Quality Compliance efforts throughout the business. The Manufacturing Engineer III primary function is to provide day to day support of the catheter manufacturing floor operations from an engineering perspective. The engineer will drive investigations tied to non-conforming product as well as processing general Non-Conformance (NC) tasks. In addition, the Manufacturing Engineer III is responsible for driving continuous improvement projects focused on the manufacturing line to reduce costs, while maintaining quality compliance, using the application of lean problem- solving tools.
Responsibilities:
Provide support as an engineering resource on cross functional teams focused on sustaining and implementing continuous improvements product lines (mostly for this site, catheter and other tubing lines…these product lines include Intra-Aortic Balloon (IAB) catheters, pacing catheters, thermodilution catheters, cholangiography catheters, sheath introducers, Berman angiographic balloon catheters, and Wedge pressure catheters, etc.).
Accountable for deliverables in good documentation practice, the design control process, and other required methods of documentation.
Process qualification and validation activities- This includes authoring and executing validation plans, engineering studies, Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ), and Test Method Validation (TMV) in accordance with ISO, FDA, and corporate guidelines
Experience with IQ/OQ/PQ and P/DFMEA is required, experience with Lean Principles is preferred.
Ensure production-specific metrics, such as yield, efficiency, etc. are met and sustained.
Lead investigations tied to Non-Conformances, Complaints, and CAPA.
Produce as team member or leader of investigative team as required for leadership or engineering technical assistance.
Lead engineering actions identified though production visual management boards.
Source, plan, present, and deliver significant projects targeted at reducing waste, increasing productivity, and reducing stress on the operations and its operators.
Demonstrate competency in the use of the tools of improvement – Six Sigma and Lean Tools associated with the Production System.
Create and update manufacturing and engineering documentation (Work Instructions, SOPs, Specifications, Engineering Drawings, etc.), and perform training as necessary.
Support R&D activities as required utilizing technical skills to provide positive input to projects and to manage the transfer process from design to manufacturing. Ensure new platforms are capable of manufacturing in a cost-efficient manner.
Coordinate with production management in planning of and implementing the necessary technical changes required to sustain adequate production line capacity.
Provide technical leadership, mentoring, and supervision of Manufacturing Technicians.
Perform additional duties as requested to support the organization's needs.
Education / Experience Requirements:
Demonstrated project management skills including but not limited to defining scope, identifying measurable results, methods, and resources necessary for improvement, timeline management and capable results.
Minimum of a Bachelor's degree in Engineering, preferably Mechanical Engineering
Minimum of 5 years' experience supporting manufacturing, preferably medical devices.
Experience with FDA QSR process and validation documentation requirements a plus.
Specialized Skills / Other Requirements
Experience with IQ/OQ/PQ and P/DFMEA.
Project management experience demonstrating the ability to meet schedule and budget targets.
Experience in the development of production test fixtures is desirable.
Proficient in most common PC based applications (Word, Excel, etc.).
Knowledge of Agile and SAP a plus.
Knowledge of six-sigma and Lean manufacturing a plus.
About our client:
Client is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. They apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers, portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
