Job Summary The Senior Process Engineer II leads the development, improvement, and deployment of manual and semi-automated manufacturing processes within a regulated production environment. This highly hands-on role requires strong technical expertise in equipment design, PLC/HMI controls, process characterization, tooling and fixture development, and production line integration. The engineer is responsible for establishing and scaling robust, efficient, and compliant processes by developing or upgrading equipment, supporting process validations, improving process capability, and leading root-cause investigations. This role partners closely with operations, quality, maintenance, engineering, and external suppliers to deliver reliable, well-documented, and sustainable manufacturing solutions that support long-term production.
Responsibilities - In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Lead the design, build, and commissioning of custom manufacturing equipment and automation systems for medical device production.
- Collaborate with R&D, Quality, and Operations to translate product requirements into scalable manufacturing solutions.
- Develop and optimize process flows, equipment specifications, and validation protocols (IQ/OQ/PQ).
- Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies to enhance throughput, yield, and reliability.
- Manage capital projects, including vendor selection and coordination, budget control, and timeline adherence.
- Ensure all equipment and processes comply with FDA, ISO 13485, and other applicable regulatory standards.
- Support root cause analysis and corrective actions for process deviations and equipment failures.
- Maintain documentation and traceability for all engineering activities, including design history files and risk assessments.
- Utilizes the systems and processes in place to attract, develop, engage, train, and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
- Perform other duties as assigned.
Qualifications Requires a bachelor's or master's degree in Mechanical, Electrical or Industrial Engineering and a minimum of eight years of experience in equipment design and process engineering, preferably in the medical device industry.
The annualized base salary range for this role is $105,060.00 to $139,587.00. Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.
