The Production Engineer II is a mid-to-senior level engineering role responsible for owning and optimizing manufacturing processes. This position plays a key role in driving production efficiency, resolving complex manufacturing issues, leading automation initiatives and ensuring compliance within regulated and quality driven environments. This role requires a hands-on engineer with a strong foundation in manufacturing processes, a data-driven mindset, and the ability to lead initiatives, coach others and implement sustainable corrective and preventative actions.

Manufacturing Support & Continuous Improvement

• Lead root cause analysis and resolution of complex manufacturing process issues using structured problem-solving methodologies.
• Develop and implement effective corrective and preventative actions (CAPA) that address systemic issues and improve long-term performance.
• Drive continuous improvement initiatives focused on safety, quality, delivery and cost.
• Provide hands-on production floor support to diagnose and resolve manufacturing issues.
• Support and influence design for manufacturability as needed.

Process Development & Optimization

• Analyze and optimize manufacturing processes using data driven methods.
• Lead and support automation projects including equipment evaluation, implementation, and optimization.
• Ensure all processes are clearly documented, controlled and accessible to enable repeatability and prevent reinvention.
• Drive measurable improvements in efficiency, throughput and waste reduction.

Documentation & Quality Systems

• Ensure adherence to regulated environment requirements and industry standards (ASTM, customer-specific, etc.).
• Standardize processes and documentation to reduce variation and improve consistency.
• Partner with Quality to ensure alignment on process controls, validation and compliance requirements.

Cross Functional Collaboration & Leadership

• Work closely with Production, Quality, Maintenance and Engineering to achieve operational goals.
• Serve as a technical resource and mentor to less experienced engineers and production staff.
• Communicate effectively across all levels of the organization and clearly articulate technical concepts.
• Demonstrate initiative, ownership, and the ability to defend technical decisions with data and sound engineering principles.

• Minimum education: Bachelor of Science in Engineering (Mechanical or related field)
• 5-10 years’ experience in a manufacturing environment
• Hands-on experience with manufacturing equipment, including computer-controlled systems
• Experience with automation and process improvement initiatives

• Strong experience with technical problem solving and root cause analysis of MFG processes
• Experience working in regulated and/or quality driven environments
• Demonstrated ability to lead or contribute to engineering projects
• Familiarity with quality management systems

• Strong analytical and data-driven decision-making skills
• Attention to detail and process discipline

• Effective communication and technical writing
• Collaboration and cross-functional teamwork
• Continuous improvement mindset
• Ability to coach, teach, and influence others