Senior Process Engineer II

Terumo Cardiovascular Group; Ann Arbor (MI); On-site; USD 105,060 - 139,587; Full time

Job summary

Terumo Cardiovascular Group is seeking a Senior Process Engineer II in Ann Arbor, Michigan. The role involves leading the development, improvement, and deployment of manufacturing processes in a regulated environment, requiring strong expertise in equipment design, process optimization, and compliance with regulatory standards.

Ideal candidates will have a degree in engineering and extensive experience in the medical device industry. The position offers competitive salary compensation based on experience and qualifications.

Qualifications

• 8+ years of experience in equipment design and process engineering, preferably in the medical device industry.

Responsibilities

• Lead design, build, and commissioning of custom manufacturing equipment.
• Collaborate with R&D, Quality, and Operations on manufacturing solutions.
• Drive continuous improvement initiatives using Lean and Six Sigma.

Skills

Equipment design

PLC/HMI controls

Process characterization

Lean methodologies

Six Sigma

Education

Bachelor's or master's 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.

Compensation

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.

Equal Opportunity Employment

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.

EOE Minorities/Women/Disabled/Veterans

Location

Nearest Major Market: Ann Arbor
Nearest Secondary Market: Detroit