Terumo Cardiovascular ยท 2 weeks ago
Senior Process Engineer II
Ann Arbor, MI
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expTerumo Cardiovascular develops, manufactures, and distributes medical devices for cardiac and vascular surgery. The Senior Process Engineer II will lead strategic initiatives to optimize manufacturing operations, focusing on equipment design and deployment to ensure efficient and compliant production.
BiotechnologyHealth CareManufacturingMedical DeviceProduct Design
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
Qualification
Required
Requires a bachelor's or master's degree in Mechanical, Electrical or Industrial Engineering
Minimum of eight years of experience in equipment design and process engineering
Preferably in the medical device industry
Benefits
401(k) with 6% matching
Paid time off
Company paid holidays
Medical, dental, vision insurance
Flexible spending account
Health savings account
Company paid life insurance
Employee assistance program
Parental leave
Tuition reimbursement
Company
Terumo Cardiovascular
Terumo Cardiovascular manufactures and markets medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass and intra-operative monitoring.
1001-5000 employees
H1B Sponsorship
Terumo Cardiovascular has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (5)
2023 (2)
2022 (2)
2021 (4)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Robert DeRyke
President and CEO
Recent News
Google Patent
2025-02-18
2025-02-18
2025-01-11
Company data provided by crunchbase