Senior Manufacturing Engineer

4 weeks ago

Bedford, United States Werfen Full time
Overview

Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. 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.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Position Summary:

Responsible for leading the process engineering and production support of a product or product line. Selected candidate should have an Electrical Engineering focus for this particular role. 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.

For this particular hire we prefer candidates that have an electrical engineering focus. The selected candidate should have experience with National Instrument's Labview and/or Teststand development. Previous medical device and/or regulated experience is a plus.

Responsibilities

Key Accountabilities

Essential Functions:

  • 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 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 (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; 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

Budget Managed (if applicable)

  • N/A

Internal Networking/Key Relationships:

  • To be determined based on department needs

Skills & Capabilities:

  • Functional/technical skills
Qualifications

Min Knowledge & Experience Required for the Position:

  • B.S. in Engineering and a minimum of 8 years of experience or an M.S. degree and at least 6 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 preferred

International Mobility Required:

  • No

Travel Requirements:

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