Infraredx, a Nipro Company
Infraredx, a Nipro Company is hiring: Sustaining Manufacturing Engineer in Bedfo
Infraredx, a Nipro Company, Bedford, MA, US
Sustaining Manufacturing Engineer
Responsibilities:
- Provides support to the Manufacturing organization to facilitate efficient operations within the production area to ensure that production goals are met.
- Troubleshoot current design and process challenges, determine root cause, and implement robust solutions.
- Support the Improvement of manufacturing procedures, inspections and test equipment necessary to improve the capabilities manufacturing.
- Implement process documentation changes and train direct labor personnel.
- Author and execute test protocols to validate manufacturing processes and equipment.
- Use Lean manufacturing methods and identify improvements to reduce costs, increase yields, and ensure product quality.
- Collaborate with contract manufacturing sites to improve product quality and achieve company goals.
- Assist in maintaining systems for regulatory compliance.
- Design, install and troubleshoot manufacturing equipment.
- Monitor performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
- Work with cross-functional groups including Product Development and Quality Engineering to analyze and disposition non-conforming products.
- Implement process and design changes to improve ergonomic issues as well as integrating products into Lean Manufacturing.
Requirements:
- Strong communication and interpersonal skills.
- Bachelor of Science Degree in mechanical, electrical, or manufacturing engineering.
- Minimum of 1-3 years’ experience in medical device manufacturing
- Experience supporting manufacturing process development, validations and qualifications
- Proficient understanding of analog/digital electronics.
- Proficiency with a variety of test equipment to include digital meters and power supplies.
- Proficiency with Microsoft Office applications and Solidworks
- Ability to interact with client companies (customer focused) and co-workers in a professional manner.
- Willingness to support other functions as needed, in areas such as quality and design.
- Willingness to travel to vendors and customer sites as needed (10% travel)
Preferred:
- Knowledge of QSR and ISO 13485 requirements for Medical Devices.
- Experience with Minitab, Statgraphics, Matlab, or Python
- Knowledge of Lean methods