|Job Type:||Full Time|
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
Support a patient temperature sensor medical device product line. Scope includes product and process improvements, along with on-going manufacturing support and training of manufacturing personnel.
- Lead and implement process improvements, both large and small scale.
- Provide on-going training and support for manufacturing, focusing on processes, equipment, and material.
- Maintain manufacturing work instructions, drawings, routings, and Bills of Material in compliance with FDA regulations, CE directives, ISO standards, and internal quality procedures.
- Manage and implement process and test method validation. This is in collaboration with Quality Engineering to write, execute, and report protocol results.
- Select, justify, and validate equipment for use in manufacturing.
- Perform problem analysis and provide corrective and preventive action plans for returned products.
- Participate on new product development teams.
- Participate in quality management review meetings.
- Verbal Communication:
- Manufacturing personnel for effective problem investigation and resolution
- Training personnel for new and changed procedures
- External with suppliers and customers
- Internal with management and other site personnel
- Written Communication
- Protocol and report writing for process validation
- Documentation of problem analysis and corrective/preventive action plans for internal and external review and action
- Manufacturing work instructions
- Proactively identify opportunities and implement process safety, quality, and cost improvements.
- Learn about new processes, materials, and equipment available for process development and improvement.
- Able to plan complex projects involving facility preparation, movement of materials and equipment, training and process validation / approval with no disruption to customers.
- Demonstrates a broad knowledge of theory and principles within a professional discipline.
- Requires ability to apply skills and knowledge in order to understand specific needs or requirements.
- Analyzes information and generates ideas.
- Develops solutions to a variety of problems of moderate scope and complexity.
- Identifies and corrects issues that are not immediately evident in existing systems or processes.
- Generally requires a Bachelors Degree in appropriate filed or local equivalent with a minimum of 3 years of progressively responsible professional level experience.
- Manufacturing engineering experience is desired.
- Knowledge and experience with statistical techniques is desirable.
- Knowledge and experience with FDA 21 CFR, CE-MDD, and ISO 13485 is desired.
- Must be US person or PRC holder due to access to products and technology controlled under the ITAR & EAR
- Basic computer skills – Word, Excel, Access, PowerPoint, data entry.
- Proficiency in ACAD
- ERP system experience (SAP preferred).
About TE Connectivity
TE Connectivity is a $13 billion global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With nearly 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.
What TE Connectivity offers:
We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.
- Generous 401(k) Plan
- Tuition Reimbursement
- Benefits start on day one
- Charity Donation Matching Program
- Competitive Paid Time Off
- Employee Resource Groups
- Employee Stock Purchase Program
- Healthcare for Associates and Families
- Health and Wellness Incentives
- Life Insurance and Disability Protection
Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.