Senior Process Engineer II

Terumo Cardiovascular Group; Elkton (MD); On-site; USD 105,060 - 139,587; Full time

Job summary

A leading medical device company in Elkton, Maryland is seeking a Senior Process Engineer II to lead the development, improvement, and deployment of manufacturing processes. This role emphasizes collaboration with operations and quality teams to ensure compliance with regulatory standards. Candidates should have a bachelor’s or master’s degree in Mechanical, Electrical, or Industrial Engineering and at least eight years of experience in the medical device industry. The annual salary range is between $105,060 and $139,587, depending on qualifications.

Qualifications

• Minimum of eight years of experience in equipment design and process engineering in the medical device industry.
• Strong technical expertise in automation systems for medical device production.

Responsibilities

• Lead the design, build, and commissioning of custom manufacturing equipment.
• Collaborate with R&D, Quality, and Operations for manufacturing solutions.
• Drive continuous improvement initiatives to enhance production.
• Manage capital projects including vendor selection and budget control.
• Ensure compliance with FDA and ISO 13485 standards.

Skills

Equipment design

PLC/HMI controls

Process characterization

Tooling and fixture development

Lean methodologies

Six Sigma

Team collaboration

Education

Bachelor’s or master’s degree in Mechanical, Electrical or Industrial Engineering

Job description

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.

Terumo Cardiovascular is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, sex, sexual orientation, gender identity and/or expression, and genetic information.