Engineer II, Applications

Cirtec - Lowell, MA

Full-time - Mid Level

Onsite - Lowell, MA

Publishing Industries

About the position

The Engineer II, Applications is a pivotal role within the EN Engineering department at Cirtec Medical Corporation, located in Lowell, MA. This position is primarily responsible for generating proposals for engineering projects that involve mechanical devices, value-added assemblies, and high-precision components. The Applications Engineer will collaborate closely with other Applications Engineering staff to collect and organize cost data for complex development proposals, ensuring that all aspects of the project are well-documented and communicated effectively. In this role, the engineer will work alongside cross-functional engineering teams to assess and document technical development plans. This includes leveraging knowledge of both existing and new assembly processes and techniques to provide innovative solutions to customer development requests. The engineer will also participate in defining the requirements, scope, timeline, and budget for new development programs, supporting the creation of budgetary project plans, development proposals, and quotations for both new and existing customers. A key responsibility of the Engineer II is to write clear and concise proposals for development programs, utilizing a variety of visual and written techniques such as graphs, diagrams, and long-form writing. The engineer will gather peer reviews on written proposals and participate in management reviews to secure the necessary approvals. Additionally, the engineer will engage in continuous improvement initiatives related to Cirtec's design control procedures and internal business processes, ensuring that the company maintains high standards of quality and efficiency. Communication with vendors and suppliers is also a critical aspect of this role, as the engineer will be involved in sourcing and developing new components. Furthermore, the engineer will analyze internal manufacturing and supply chain data to assess actual costs and estimate future production costs, contributing to the overall financial health of the projects undertaken.

Responsibilities

• Collaborates with cross-functional engineering teams to assess and document technical development plans.
• Applies engineering skills to evaluate and recommend technical solutions to customer development requests.
• Participates in defining requirements, scope, timeline, and budget for new development programs.
• Supports the development of budgetary project plans, development proposals, and quotations for customers.
• Writes proposals for development programs using clear technical communication skills.
• Gathers peer reviews on written proposals and participates in management reviews for approvals.
• Participates in continuous improvement of design control procedures and internal business processes.
• Communicates with vendors and suppliers for sourcing and development of new components.
• Analyzes internal manufacturing and supply chain data to assess actual costs and estimate future production costs.
• Performs other duties as assigned.

Requirements

• BS in Biomedical / Mechanical / Electronics / Computer engineering discipline with at least 3 years of experience within the medical device industry.
• Experience working on medical device development projects from design through transfer to production.
• 3+ years' experience in the engineering / manufacturing environment of medical device component assembly.
• Experience with active implant devices or implantable components preferred.
• Strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
• Ability to interpret technical drawings, product requirements, design specifications, and relevant technical documents.
• Proficiency in MS Office software.
• Fluent in reading, writing, and speaking English.
• Excellent written and oral communication skills in English.

Nice-to-haves

• Experience with active implant devices or implantable components preferred.