embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and Twitter.
SUMMARY JOB DESCRIPTION:
Are you Test Engineer passionate about medical devices and finding new and innovative ways of testing them to their limits to improve safety and reliability? Do you have experience building automated testing environments for both physical and emulated testing? embecta - Diabetes Care is searching for a Staff Software/Hardware Test Engineer who will support the team in design, development and commercialization of new wearable diabetes care products. We are recruiting for a highly driven Staff Software/Hardware Test Engineer with a proven track record of successfully testing medical products. The Staff Software/Hardware Test Engineer will report to the Senior Firmware Manager.
RESPONSIBILITIES:

• Design and implement automated test frameworks, tools, and processes to improve testing efficiency and effectiveness
• Develops and optimizes physical test methods and test fixtures to support the design verification, validation, and commercialization of new medical device products
• Performs hands-on and simulated testing for design verification and test method developments
• Drafts engineering technical reports, test method work instructions or procedures and test method validation related documents
• Plans, leads/executes test method validation (TMV) in preparation for design verification testing for regulatory submissions
• Authors and executes design verification test protocols in support of regulatory submissions of Class II (or Class III) medical devices
• Conducts functional and performance testing of products to ensure that the product and its components meet the required specifications
• Authors and executes software unit test protocols to ensure that the software units function as designed
• Applies sound engineering principles and practices to the design and testing of medical devices
• Executes routine and non-routine mechanical and analytical testing to support the development, verification or validation of new products
• Participate in cross-functional product design to ensure testability and work collaboratively with the R&D team on all levels of testing, ranging from unit to verification testing
• Support the R&D team in data review, analysis, and interpretation. Identifies and reports out of specification results, data, and atypical/unexpected events that occur during testing activities and supports associated investigations, impact assessments and Root Cause Analysis (RCA)

Minimum Qualifications:

• 10 years of test experience in a medical device environment
• Experience with writing software & electrical hardware protocols
• Experience with executing software & electrical hardware protocols
• Proficiency in using Lab Tools such as Oscilloscopes and Data Loggers
• Strong interpersonal skills
• Proven track record of effective teamwork

DESIRED Qualifications:

• Ability to lead strategies with tools and Automation Frameworks especially on Embedded Devices.
• Experience with Requirement Management Tools (eg, Modern Requirements)
• Proficiency in pipeline automation/Source Code Repositories using Azure DevOps or similar
• Test implementation using languages such as Python, C, C#, and VectorCAST
• Experience with Static Analysis tools (eg, Coverity)

embecta is an Equal Opportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.