Lead Manufacturing Engineer

2 weeks ago

Spencer, United States Gateway Recruiting, INC. Full time
Job Overview

Position Summary:
The Senior Manufacturing Engineer is pivotal in driving initiatives that support product lines, processes, materials, and machinery. This role is crucial for the seamless integration of new products into production, ensuring adherence to integration timelines and production objectives, including safety, quality, delivery, cost efficiency, and productivity. The individual will collaborate extensively with cross-functional teams to assess, troubleshoot, and enhance manufacturing processes within the organization.

Key Responsibilities:

  • Collaborates effectively with R&D, Process Development, Quality Assurance, Production, Regulatory Affairs, Equipment Engineering, Supply Chain, and Marketing on intricate projects to ensure successful outcomes.
  • Generates innovative solutions to complex challenges, contributing to departmental objectives.
  • Completes sophisticated engineering tasks and supports new product development initiatives, including technology advancement, material testing, specification preparation, Six Sigma methodologies, process analysis, and reporting.
  • Ensures that newly introduced products meet business, quality, output, and cost targets.
  • Selects appropriate process improvement methodologies to address technical challenges and provides sound recommendations for equipment and process enhancements.
  • Designs and oversees relevant engineering tests and experiments.
  • Analyzes and interprets complex test data to draw meaningful conclusions.
  • Prepares engineering documentation and communicates findings to both technical and leadership audiences.
  • Manages project objectives and progress, suggesting necessary adjustments.
  • Evaluates the feasibility and integrity of proposed engineering tests, products, or equipment.
  • Oversees and manages Capital Equipment Request Authorizations (CERA's).
  • Leads cross-functional project teams effectively.
  • Drives the identification, implementation, and management of Business Unit objectives and contributes to the development of the multi-year strategic plan.
  • Provides training and mentorship to team members, including engineers, technicians, and production staff, fostering the development of junior personnel through guidance and support.
  • Demonstrates a strong commitment to patient safety and product quality by adhering to the Quality Policy and all relevant quality processes and procedures.

Required Qualifications:

  • Bachelor's Degree in an Engineering discipline.
  • 5+ years of experience in manufacturing, process, or related engineering fields.
  • Proven ability to resolve advanced technical issues.
  • Experience in qualifying complex machinery.
  • Familiarity with lean manufacturing principles.
  • Ability to manage multiple projects concurrently.
  • Strong proactive approach and capability to prioritize tasks effectively in a dynamic environment.
  • Experience with manufacturing problem-solving and process improvement tools such as DMAIC and LEAN methodologies.
  • Proficiency in data analysis and statistical tools like Minitab.
  • Willingness to travel up to 5%.

Preferred Qualifications:

  • Master's Degree.
  • Experience in medical device manufacturing technologies, including but not limited to: shape forming of metals and plastics, laser welding, ultrasonic welding, adhesives, injection molding, laser marking, inkjet printing, laser cutting, pad printing, and sterile barrier sealing.
  • Basic understanding of automation, PLC programming (Allen-Bradley), and machine vision systems (Cognex & Keyence).
  • Familiarity with 3D modeling software such as Solidworks.
  • Basic knowledge of business intelligence tools like PowerBI and Tableau.
  • Experience with PTC Windchill Product Lifecycle Management software or similar platforms.
  • Demonstrated ability to communicate effectively with various stakeholders at different organizational levels, as well as with suppliers and equipment vendors. A continuous improvement mindset is essential.

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