Principal Manufacturing Engineer at Werfen GmbH

Bedford, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Apr, 26

Salary

190000.0

Posted On

12 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Improvement, Technical Leadership, Problem Solving, Manufacturing Quality Plan, Lean Six Sigma, Engineering Design, Continuous Improvement, Collaboration, Documentation, Validation, Assembly Methods, Test Methods, Equipment Operation, Root Cause Analysis, Research, Cost Analysis

Industry

Medical Equipment Manufacturing

Description

Introduction Werfen 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. Responsibilities Key Accountabilities: Responsible for the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions. 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 asse. Responsible for establishing the Manufacturing Quality Plan (MQP) 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; Collaborates 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 Budget Managed (if applicable): N/A Internal Networking/Key Relationships: To be determined based on department needs Skills & Capabilities: Ability to plan and conduct work requiring the application of extensive and diversified knowledge of engineering principles in broad areas of assignments Ability to maintain a clear overview of major projects, make sound judgments necessitated by available time and technical capacity to meet set objectives Qualifications Min Knowledge & Experience Required for the Position: B.S. in Engineering and a minimum of 15 years of experience or an M.S. Degree and a minimum of 10 years of experience Experience in technical support for the manufacturing of instrumentation and/or disposables preferred Experience in Lean and Six Sigma problem solving methodologies preferable International Mobility Required: No Travel Requirements:

Responsibilities

The Principal Manufacturing Engineer is responsible for leading process engineering and production support for a product line, focusing on continuous improvement and optimization. This includes resolving production process issues, providing technical leadership, and establishing the Manufacturing Quality Plan.