Process Engineer II

Responsibilities

• Contribute as an individual contributor within cross-functional teams that include engineering, operations, and quality.
• Provide input on process design and manufacturability throughout the product development lifecycle, supporting verification, validation, and regulatory submissions.
• Drive continuous improvement initiatives to optimize processes, reduce costs, and meet customer requirements.
• Develop, implement, and refine manufacturing processes for new and existing products.
• Create production fixtures using CAD tools to enhance consistency, reduce quality issues, and improve operational efficiency.
• Conduct time studies and create process flow maps to identify bottlenecks and implement improvements that drive efficiency and throughput.
• Troubleshoot and resolve issues with equipment, programs, and processes in production.
• Design and improve machines, tooling, and fixtures to enhance efficiency and quality.
• Author and execute process validation activities (IQ, OQ, PQ) in compliance with regulatory standards.
• Collaborate with product development teams to ensure designs are optimized for manufacturability and assembly (DFMA).
• Lead structured problem-solving efforts using root cause analysis and statistical tools to prevent recurrence of non-conformities.
• Respond to customer complaints and implement corrective and preventive actions.
• Apply project management principles to deliver improvements on time and within scope.
• Mentor and lead engineers and technicians in supporting manufacturing operations and improvement projects.

Requirements

• Education: Bachelor’s degree in Engineering (required).
• Experience: 2–4 years in manufacturing or medical device industry (medical device experience preferred).
• Ability to work independently and influence teams toward achieving business objectives.
• Experience across the medical device lifecycle, including design verification, process validation, and technology transfer (preferred).
• Six Sigma Green/Black Belt certification (preferred).
• Proficiency in statistical analysis (e.g., k-factors, Ppk, DOE) and root cause analysis.
• Skilled in CAD software (SolidWorks preferred).
• Strong knowledge of process validation (IQ, OQ, PQ), test method validation, measurement systems analysis (MSA), and structured problem-solving.
• Ability to write clear, operator-friendly manufacturing work instructions.
• Leadership experience in guiding engineers and technicians in manufacturing support.