Sr. Manufacturing Engineer

Terumo•Caguas, PR

About The Position

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. Join us and help shape wherever we go next! Advancing healthcare with heart

Requirements

Knowledge of FDA, GMP, and ISO guidelines is required.
Strong statistical techniques knowledge (DOE, SPC) is required.
Strong computer software knowledge (Microsoft Word, Excel, Power Point).
Knows concepts, practices, and procedures of a particular field of specialization.
Effective communication and presentation skills.
Fully Bilingual (English and Spanish).
Willing to travel and work under pressure.
BS in Engineering
Minimum 7 years of experience in a related engineering role (preferably in the medical device industry).

Nice To Haves

master degree is a plus.
PE license is a plus.

Responsibilities

Performs a variety of engineering assignments to meet quality standards in the most cost efficient manner.
May supervise and provide technical assistance to exempt and non-exempt personnel.
Works closely with production and quality departments and have manufacturing engineering responsibility for products at production level.
Qualifies equipment or processes.
Responsible for the approval of procedures change request and qualifications documents.
Designs project tasks to bring project to completion and work effectively with cross-functional teams.
Daily support to manufacturing activities to meet established goals.
Accountable for the equipment maintenance, setups & troubleshoot.
Responsible to provide necessary information to maintain appropriate spare parts inventory and evaluation of replacements for obsolete components.
Report equipment downtime and scrap per unit metrics.
Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions.
Work with finance to define project costs and financial analysis.
Responsible for writing, executing and approving equipment/process qualifications.
Responsible for writing and approving change requests.
Perform investigations of equipment and process issues to identify root cause, implement controls to eliminate causes, and assess the effectiveness of the controls.
Ensure compliance with all Company procedures and all applicable regulatory agency requirements.
Other duties as assigned.