Senior Manufacturing Engineer II

Werfen•Bedford, MA

17h•$145,000 - $170,000

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Position Summary Responsible for leading the process engineering and production support of a product or product line. Provides technical leadership and support for continuous improvement team efforts focused on process improvement and optimization. Provides engineering leadership for the design, documentation and implementation of assembly methods, test methods, equipment operation, including specification and optimization.

Requirements

B.S. in Engineering and a minimum of 12 years of experience or an M.S. Degree and at least 8 years of experience
Functional/technical skills
Travel requirements: <5% of time

Nice To Haves

Experience in technical support for the manufacturing of instrumentation and/or disposables preferred
Experience in Lean and Six Sigma problem solving methodologies preferred

Responsibilities

Responsible for the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions
Responsible for delivering long-term cross functional impactful projects on time and on budget
May be required to act as Product Champion for a specific product or product line with the following leadership responsibilities
The focal point in operations for the products which they have responsibility for.
Leads the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions.
Leads the process engineering and production support activities required for the manufacture of a product line.
Provides technical support and leadership for continuous improvement team efforts focused on process improvement and improvements to product manufacturability.
Provides technical leadership and hands-on engineering support, including specification and implementation of assembly/test methods and process optimization.
Provides technical support for continuous improvement efforts conducting root cause analysis then formulating and implementing corrective action proposals
Responsible for establishing the Manufacturing Quality Plan (MOP) for a product or product line including process flow, production floor layout, equipment, line balancing, etc.
Writes process procedures, change orders, equipment specifications, validation plans, and reports
Performs research on technology, equipment, and tooling to improve process quality, yield, or cost; Generates proposals for purchase and implementation, including cost of ownership, ROI and benefit analysis
Performs engineering design of test equipment, assembly equipment, fixtures, and tools; Performs IQ/OQ/PQ validation activities
Participates in the introduction of new products into manufacturing; Collaborate with R&D and suppliers to improve product robustness and manufacturability both pre- and post release
Supervises (as assigned) personnel in classifications below that of Senior Mfg. Engineer
May lead or participate in Lean Six Sigma projects of significant scope and complexity