Posted on 20 Jan 2026

Senior Process Engineer

Kennesaw, GA
Permanent
$120,000 - $135,000

We're seeking a hands-on Process Engineer to support manufacturing operations, drive process improvements, and ensure seamless product launches. This role is critical in optimizing efficiency, improving product quality, and maintaining compliance across all production processes. 

7% annual bonus & $4,900 equity available. 

Key Responsibilities

  • Provide engineering support to manufacturing to ensure adherence to SOPs, quality standards, and regulatory requirements.
  • Coordinate and manage multiple concurrent engineering changes related to materials, tooling, equipment, and manufacturing processes throughout the product lifecycle.
  • Collaborate cross-functionally with Operations, Quality Engineering, Quality Assurance, Regulatory, R&D, Purchasing, and Facilities.
  • Lead process optimization initiatives to improve yield, reduce cycle time, minimize defects, and improve overall manufacturing efficiency.
  • Serve as Subject Matter Expert (SME) for commercial products and their associated manufacturing processes, assessing downstream impacts to DV&V, shelf life, and distribution.
  • Lead business continuity and second-source initiatives by identifying, qualifying, and implementing alternative materials, suppliers, or processes to prevent line downtime.
  • Troubleshoot complex equipment and process issues, providing root cause analysis and final disposition recommendations when escalated.
  • Lead the startup, debugging, qualification, and validation (IQ/OQ/PQ) of new equipment and processes.
  • Develop, revise, and approve manufacturing documentation, including work instructions, process flows, Device Master Records, and drawings using CAD software.
  • Conduct statistical analysis and technical studies using Minitab to support process capability, validation, and continuous improvement efforts.
  • Provide technical support to key suppliers and equipment vendors.
  • Support audits, CAPAs, and regulatory submissions as required.
  • Mentor and provide technical guidance to junior engineers.
  • Lead or support corporate initiatives aligned with departmental and operational objectives. 

Qualifications 

  • Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related discipline).
  • Typically 7-9 years of experience in medical device, tissue processing, or regulated manufacturing environments.
  • (5-7 years with a Master's degree).
  • Proficiency with Minitab statistical software.
  • Working knowledge of CAD systems.
  • Experience with engineering change management and process validation.
  • Lean Manufacturing/5S/Green Belt experience preferred.
  • Experience with tissue processing and/or chemical processing is a plus.

Success In This Role

  • Strong analytical and problem-solving skills.
  • Ability to conceptualize and optimize complex manufacturing workflows.
  • Solid understanding of cost analysis and business impact.
  • Proven ability to manage multiple projects simultaneously.
  • Demonstrated leadership and mentoring ability.
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