STAFF MANUFACTURING ENGINEER

Job Overview

TE’s Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs a complete product offering, and capable portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic devices. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the world’s leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine, to sensors & connectors for surgical applications. Our innovative solutions enable groundbreaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries, and powering robotic surgery.

Responsibilities

• Lead and support department and plant level technical initiatives.
• Lead cross-functional improvement activities with manufacturing engineering, quality, supply chain, operations, and external customers.
• Collaborate directly with operations through daily tier meetings, day to day support, troubleshooting, and technician direction for responsible production lines.
• Lead cost of poor quality/yield improvement through medium to large scale projects.
• Author and route deviation authorizations and documentation change plans.
• Root cause analysis.
• Establish oneself as a technical subject matter expert within the manufacturing engineering department.
• Establishing and executing engineering studies, capability assessments and characterization efforts.
• Equipment insourcing, improvement, and validation.
• Adhering to quality and compliance standards to ensure safe and effective use of the devices TE manufactures.
• Train, coach, and mentor less experienced engineers and technicians.
• Fixture design, development, and implementation.

What your background should look like:

• Positive, adaptable attitude that thrives in a dynamic, fast-paced environment
• Bachelors Degree in Science, Engineering or related subject
• 8+ years experience in a medical device manufacturing environment preferred
• Demonstrated ability to coach, mentor, and develop technical peers
• Catheter assembly or molding manufacturing experience preferred
• Deep experience with structured problem-solving processes, such as 5-Why, 8-Step A3, and/or DMAIC/Six Sigma.
• Strong statistical analysis skills (process capability, equivalence studies, ANOVA, DOE)
• Knowledge of job requirements in medical industry (FDA regulations).
• Experience in process improvement, product and process qualification and validation
• Knowledge of measuring instruments, sampling plans.
• Well-developed writing skills.
• Ability to work independently with little or no supervision, as well as in a team settings
• Effective interpersonal skills and adeptness in working with culturally diverse employee population
• Ability to effectively communicate verbally and in writing; proficiency in English required
• Proficiency in Microsoft Office tools such as MS Word, MS Excel, MS PowerPoint
• Lean/Continuous Improvement experience a plus
  

Competencies