Process Engineer

SUMMARY: Red Star Manufacturing is seeking a dedicated Process Engineer to support the New Product Introduction (NPI) function, with primary responsibility for translating new customer products and designs into efficient, scalable manufacturing processes. This role partners closely with customers, engineering, and operations to ensure successful product launches from initial concept through production readiness. The Process Engineer will lead process development for new products, evaluate manufacturability, and define how products will flow through production. In addition, this role will support continuous improvement and troubleshooting of existing processes as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)

• Analyze current manufacturing methods and identify opportunities for improvement.
• Develop and implement strategies to enhance production efficiency, quality, capability, and utilization.
• Lead the integration of new products into manufacturing processes, including defining process flow, equipment requirements, and production readiness as part of the NPI function.
• Partner with customers and cross-functional teams to evaluate product designs for manufacturability (DFM) and ensure successful new product launches.
• Define how new products will flow through production, including routing, work instructions, and process controls prior to release.
• Estimate production timelines, labor requirements, and costs to support quoting efforts for new business and new product introductions.
• Identify key suppliers and manage the quoting process for new materials and outside processing needs.
• Work with maintenance personnel to prevent problems with machinery and related equipment.
• Conduct root cause analysis to determine underlying issues and implement solutions to prevent recurrence.
• Ensure all manufacturing product specifications, documentation, and process requirements are developed, validated, and in place prior to release to production.
• Assist with training set-up associates on new product launches to meet target dates.
• Assist Quality with support for validations, first articles, PFEMAs, DOEs, and inspection criteria.
• Support continuous improvement of existing processes while maintaining primary ownership of new product introduction activities.

QUALIFICATION REQUIREMENTS:

• BS in Mechanical or Manufacturing Engineering, preferred.
• 5+ years of experience in process engineering, preferably in a medical device or contract manufacturing environment.
• Demonstrated experience supporting new product launches and working in cross-functional engineering or NPI teams.
• Ability to work effectively in a team environment and collaborate across departments.
• Ability to manage projects, timelines, and deliverables in a fast-paced, customer-driven environment.

OTHER SKILLS AND ABILITIES:

• Strong analytical and problem-solving skills, with the ability to apply scientific and statistical thinking to manufacturing processes.
• Experience with New Product Introduction (NPI), including process development, validation, and product launch execution.
• Ability to evaluate product designs for manufacturability (DFM) and translate customer requirements into efficient production processes.
• Proficiency with Microsoft Office (Word, Excel) and CAD software; ability to read blueprints and interpret solid models.
• Knowledge of manufacturing processes, tooling, and mold design (insert molding experience highly desirable).
• Familiarity with process validation and documentation tools (e.g., PFMEA, Control Plans, DOE).
• Hands-on experience with precision measurement and inspection equipment.
• Strong project management, organizational, and communication skills, with the ability to manage multiple priorities and collaborate cross-functionally and with customers.