Sr. Engineer I - Process Engineering

Terumo Medical Corporation • Elkton, MD

390d

About The Position

The Sr. Engineer I - Process Engineering position at Terumo Medical Corporation is focused on providing advanced engineering support for product process transfer projects, process improvements, and new product development. The role emphasizes compliance with quality and regulatory standards while fostering innovation and collaboration within a team dedicated to enhancing healthcare outcomes.

Requirements

• BS in Mechanical, Biomedical, or similar engineering discipline from an accredited university or college.
• 7 or more years of working experience with increasing responsibility in Product and Process Development in the medical device field.
• Experience in the development of new manufacturing processes for global Medical Devices or other highly regulated industries.
• Experience in Design for Manufacturability (DFM), Design for Assembly (DFA), and Lean Six Sigma principles and tools.
• Strong analytical and problem-solving skills with the ability to solve complex problems and implement solutions.
• Demonstrated ability in the design, development, and implementation of new medical device production processes.
• Strong communication skills, with the ability to explain complex engineering problems to non-engineering personnel.

Nice To Haves

• Experience with FDA design control guidelines.
• Familiarity with cross-functional interactions in product and manufacturing process development.

Responsibilities

• Provide engineering support to the design, development, and qualification of products, processes, and process equipment in compliance with TMC QA101 Product Development & Design Controls.
• Participate in the design and development of new products, offering manufacturability insights to facilitate viable production processes.
• Serve as a Process Leader for the development or transfer of production processes, ensuring overall performance and validation requirements are met.
• Lead and participate in formal process validations, ensuring compliance with validation protocols and documentation practices.
• Install production/process equipment and support Installation Qualification (IQ), Operational Qualification (OQ), and formal PQ validation activities.
• Act as a Problem Solver for product and process issues, applying engineering tools and techniques for resolution.
• Contribute to project team meetings, Design Reviews, and project planning activities, including cost and schedule estimates.
• Prepare and present technical presentations to various personnel levels, effectively communicating technical activities.

Benefits

• Competitive salary
• Health insurance
• 401k plan
• Paid time off
• Professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees