Job Type
Full-time
Description
The Process Engineer II is responsible for supporting and improving the manufacturing of Class II medical and surgical devices within a dynamic, customer-focused organization. This role involves collaborating with customers to understand product and process requirements, developing robust manufacturing processes, and ensuring devices meet specifications. All activities must comply with design control requirements and be documented in the Design History File (DHF).
ResponsibilitiesAs a Process Engineer II, you will contribute as an individual contributor within cross-functional teams that include engineering, operations, and quality. You will 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.
- Design and build 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.
