Sustaining Engineer

Under routine supervision, primarily responsible for the continuation and enhancement of existing products. Involved in Supply Chain improvements, projects including CAPAs and audit responsesOther responsibilities include drafting and modification of design history file documents, development of test plans to assess designs, and assisting in the review processes for Manufacturing, Quality Control, Regulatory and Planning for their particular project.

Essential Duties and Responsibilities • Ability to partner with cross functional organizations to successfully drive the business (relationship building skills is key - influencing - working through people)• Solid working knowledge of quality and regulatory requirements, plus experience dealing with regulatory agencies or outside professional groups (e.g. FDA,.• Must be a strong communicator, verbal and written, across all levels of the organization as well as cross functionally• Must be an extensive multi-tasker, and problem solver with high energy levels and strong organizational abilities. Must be organized and attentive to details, and must have strategic and tactical thinking• Generates design assurance documentation for the project Design History File (DHF).• Problem solving, priority setting, customer focus and driving for results• Initiates design changes relative to manufacturability while maintaining critical features for in house manufacturing or vendors• Assists Project Engineers with providing technical expertise to Regulatory Affairs to support FDA 510(k) submissions and/or international registrations.• Creates and processes Change Orders (CO's)• Other duties as assigned.

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to work independently, but equally in a team environment

• Strong written and verbal communication skills and attention to detail

• Self-starting, detailed oriented, quick learner, creative and analytical

• Capable of understanding and analyzing complex engineering problems

• Demonstrated leadership, and ability to solve problems and communicate issues

• Understanding of documentation system and management

• Preferable knowledge of Quality System Requirements (QSR), ISO 13485, TGA, PMDA, other international regulations and compliance thereof

• Experience in an FDA regulated environment required

• Microsoft Office knowledge, including Word, Excel.
• Experience with Vantage and/or SAP ERP system is a plus.
• Experience with Agile Product Lifecycle Management System is required

• Ability to communicate effectively with all levels of the organization

• Ability to prioritize multiple projects

• Ability to resolve conflicting interests, build relationships and obtain cooperation

• Additional duties as assigned

Education and Experience

• Undergraduate degree in an engineering or science discipline preferred.
• 3-5 years Medical device experience required.
• Experience with quality system elements pertaining to medical devices and QSR, cGMP, MDSAP and ISO 13485 familiarity is preferred.
• Knowledge in the use and interpretation of geometric dimensioning and tolerancing, preferred

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.