Lead Process Engineer for Operations Excellence

1 month ago

Hartwell, Georgia, United States Coghlin Companies Inc Full time

Benefits: 401(k) with matching contributions, competitive salary.

Company Overview: Coghlin Companies Inc. specializes in providing comprehensive manufacturing solutions to a diverse array of medical Original Equipment Manufacturers (OEMs), ensuring the delivery of innovative products with stringent quality assurance and full regulatory adherence.

Position Overview: The Senior Operations Process Engineer will play a pivotal role in guiding and enhancing manufacturing processes within a medical device production environment that adheres to FDA and ISO 13485 standards.

This role involves both independent and collaborative work, focusing on the design and refinement of manufacturing workflows throughout all stages of the product lifecycle.

A key responsibility will include supporting the design, initiation, and management of a high-capacity automated assembly line that employs RF sealing technology and robotic pick-and-place systems in a controlled setting.

The Senior Operations Process Engineer will be essential to the Operational Excellence initiatives at Coghlin Companies, utilizing statistical methodologies to propose enhancements and lead Continuous Improvement (CI) projects.

Key Responsibilities:

  • Develop and optimize manufacturing processes from concept through to validation and full-scale production.
  • Conduct engineering assessments of process performance and identify opportunities for enhancements focused on safety, efficiency, and risk management.
  • Create preventative and predictive maintenance strategies, troubleshoot manufacturing process issues, and produce relevant technical documentation.
  • Lead and facilitate Continuous Improvement efforts, including Kaizen events and structured problem-solving sessions.
  • Design and optimize cell layouts for Operational Excellence using lean manufacturing principles.
  • Research and test to innovate or enhance manufacturing processes.
  • Support other engineering functions during installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) validations.
  • Provide project management and technical guidance for company-wide process enhancement initiatives.
  • Maintain and advance established Continuous Improvement programs.
  • Train and develop equipment technicians and production leads for effective daily operations.
  • Act as a Subject Matter Expert (SME) on automation, tooling design, and process optimization initiatives.
  • Perform additional duties as required.

Qualifications:

  • Bachelor's degree in Mechanical Engineering or a related engineering field, with a minimum of 5 years of experience in manufacturing or process engineering.
  • Experience in machine-based repetitive manufacturing or similar processing industries is essential.
  • Proficiency with manufacturing machinery, automation, and control systems is required; knowledge of RF welding is a plus.
  • Familiarity with controlled environment protocols in an ISO 13485 and FDA-compliant setting is crucial.
  • Experience in the production of disposable medical devices is advantageous.
  • Desirable skills include programming machine controls using HMI or offline software.
  • Six Sigma certification (Green or Black belt) and expertise in lean manufacturing methodologies are highly valued.
  • Experience with Design for Manufacturing and Assembly (DFMA) techniques and developing tools/fixtures for process optimization is beneficial.
  • Ability to design manufacturing lines considering takt time, capacity analysis, and cycle times.
  • Experience in creating detailed process work instructions and other procedural documentation.
  • Must be a self-motivated individual capable of working with minimal supervision, possessing strong technical, analytical, and interpersonal skills.
  • Excellent written and verbal communication skills are required.
  • Must be organized, capable of exercising sound judgment, and adept at managing multiple projects and tasks simultaneously.
  • Proficiency in MS Office applications, including Word, Excel, Visio, MS Project, Access, and PowerPoint.
  • Experience with SolidWorks and statistical software (e.g., Minitab) is preferred.
  • Ability to lead and inspire team members is essential.

Work is conducted in a controlled environment or light industrial production area. The role may require standing for extended periods, walking, and reaching with hands and arms, as well as lifting and moving items up to 50 pounds.

Note: The above statements are intended to convey the general nature and level of work performed by employees in this role. They are not intended to be an exhaustive list of all responsibilities, duties, or skills required.

Coghlin Companies Inc. is an Equal Opportunity Employer. We do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis protected by law. All employment decisions are made based on qualifications, merit, and business needs.

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