Entry Level Controls Engineer Jobs in Dracut, MA

This position is intended to be an entry level position focused on software functional testing and quality assurance, and the fulfillment of relevant procedure and documentation per Fujifilm Medical Informatics Design Control process for software development.

Duties and responsibilities

• Learn and become proficient about the Synapse Select product line, including deployment methods and deployment architecture for both on-premise and cloud configurations.
• Assist in the creation and execution of manual Software test cases for Verification and Validation protocols with the Synapse Select product line.
• Occasional exploratory functional testing and ticketing of any issues found.
• Reproduce and document any product defects and/or reported bugs in the JIRA development ticketing system.
• Execute individual development ticket and regression testing with clear documentation of test results.
• Correspond with Software and Template Engineering, give feedback to any questions they may have, and facilitate the provision of more information if needed.
• Participate in calls with contractor QA team(s) on the grooming of development tickets to become more knowledgeable about the product
• Participate in calls with the automated testing team for reviewing implementation of new test cases.
• Create, Design Forms as required by the Medical Informatics Design Control Process for Synapse Select products as needed.
• Assist the Medical Informatics documentation team in the creation and maintenance of service manuals and product documentation for Synapse Select.
• Assist Operations and Support with technical questions related to the Synapse Select product line.
• Additional responsibilities as defined by management.
• Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

Qualifications

Educational Requirements:

• Bachelor's Degree (B.S./B.A.) or equivalent work experience in a scientific or technical discipline.

Experience:

• 0 to 2 years of experience in Software Development, Software QA or other related fields
• Practical Experience or knowledge about Software Development, testing, or Software QA
• Basic knowledge of software medical devices, procedures, and terminology, including the DICOM standard and HL7.
• Basic Knowledge of AGILE Software development and software design controls.
• Experience with Microsoft Word, Excel, Visio, and Access or equivalent software.
• Strong interpersonal, verbal, and written communication skills

Special Skills or Other Job Requirements:

• Detail oriented.
• Problem solving
• Ability to multi-task.
• Highly organized.
• Excellent verbal, written, and communication skills.

Physical requirements

The position requires the ability to perform the following physical demands and/or have the listed capabilities:

• Usual office working conditions.
• Frequently required to sit, talk, or hear.
• Good manual dexterity.
• Ability to sit for extended periods.
• Occasionally lift and/or move up to 10 pounds.

Travel

• Occasional (up to 10%) travel may be required based on business need.

In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. Applicants to positions where vendor credentialing or other similar requirements exist to enter facilities will be required to comply with the credentialing requirements of the facilities, including complying with vaccine requirements. For all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (hcushr.department@fujifilm.com or (330) 425-1313).