Lead Manufacturing Process Engineer

2 weeks ago

Bedford Massachusetts, United States Werfen Full time

Overview:
Werfen

Werfen is a dynamic, family-owned enterprise established in 1966 in Barcelona, Spain.

We are a global frontrunner in specialized diagnostics, focusing on Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplantation.

Through our Original Equipment Manufacturing (OEM) division, we engage in the research, development, and production of tailored assays and biomaterials. We have a direct presence in 30 countries and extend our reach to over 100 territories through distributors.

Our Headquarters and Technology Centers are situated in the US and Europe, employing a workforce exceeding 7,000 individuals.


Our achievements stem from a dedicated focus on these rapidly advancing diagnostic fields, our unwavering commitment to our clients, and our passion for innovation and quality.

We are devoted to equipping healthcare professionals with the most comprehensive and effective solutions to enhance hospital efficiency and improve patient care.


Position Summary:
This role entails spearheading the engineering processes and production support for a specific product or product line. The individual will provide technical guidance and support for continuous improvement initiatives aimed at optimizing processes.

They will also offer engineering expertise for the design, documentation, and execution of assembly methods, testing protocols, and equipment operations, including specifications and enhancements.


Responsibilities:

Key Accountabilities:


Address production process challenges by employing problem-solving methodologies to analyze, identify root causes, and develop and implement effective solutions.

May serve as the Product Champion for a designated product or product line, assuming the following leadership duties:

Act as the primary contact in operations for the products under their purview.

Lead the resolution of production process challenges using analytical techniques to determine root causes and implement solutions.

Oversee the engineering processes and production support activities necessary for the manufacturing of a product line.

Provide technical support and leadership for continuous improvement teams focused on enhancing process efficiency and product manufacturability.

Deliver technical leadership and hands-on engineering assistance, including the specification and implementation of assembly methods.


Establish the Manufacturing Quality Plan (MQP) for a product or product line, encompassing process flow, production floor layout, equipment selection, line balancing, and more.

Draft process documentation, change orders, equipment specifications, validation plans, and reports.

Conduct research on technologies, equipment, and tooling to enhance process quality, yield, or cost-effectiveness.

Prepare proposals for acquisition and implementation, including ownership costs, ROI, and benefit analyses.

Engage in the engineering design of testing equipment, assembly tools, fixtures, and devices; execute IQ/OQ/PQ validation activities.


Participate in the integration of new products into manufacturing; collaborate with R&D and suppliers to bolster product robustness and manufacturability both prior to and following release.

Supervise personnel assigned to roles below that of Senior Manufacturing Engineer.

May lead or contribute to Lean Six Sigma projects of considerable scope and complexity.

Internal Networking/Key Relationships:
To be determined based on departmental requirements.

Skills & Capabilities:
Ability to plan and execute work requiring extensive and diverse knowledge of engineering principles across a wide range of assignments.

Capacity to maintain a comprehensive overview of major projects, making sound judgments based on available time and technical capabilities to achieve set objectives.

Qualifications:

Minimum Knowledge & Experience Required for the Position:
B.S. in Engineering with a minimum of 15 years of experience, or an M.S. Degree with at least 10 years of experience.

Preferred experience in technical support for the manufacturing of instrumentation and/or disposables.

Experience with Lean and Six Sigma problem-solving methodologies is advantageous.

International Mobility Required:
No

Travel Requirements:

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