Senior Systems Test Engineer

Job Description

The Senior Systems Test Engineer will be an integral member of new product development team at Bracco Medical Technologies (BMT), focused on fixtures and test methods for next generation cardiovascular and diagnostic medical devices.

You will be responsible for evaluation, development, and implementation of test systems/tools/equipment, including design documentation. The position will provide Verification and Validation expertise to new product introduction of electro-mechanical, software controlled medical devices.

Primary Duties & Responsibilities:

• Execute test planning, test design and testing issue resolution during development to ensure that all medical devices are built in accordance with customer, business, and regulatory requirements.
• Provide leadership and execution of best test method practices as part of a project team.
• Collaborate with cross-functional team members from a wide range of departments as well as with suppliers during design transfer.
• Design clean, easy to use user interfaces for test equipment that measures robustness of design, provide error-checking, collects data and gives user feedback for acceptance and/or failure.
• Create and maintain traceability of test cases to requirements

• Write and execute verification & validation protocols for test equipment per company procedures

• Provide input supporting submissions to and audits for regulatory bodies and governmental agencies.
• Use critical thinking and technical knowledge to solve complex system interaction problems
• Drive systems engineering center of excellence as key discipline across the organization.
• Perform work in adherence to the Bracco Medical Technologies (BMT) Quality Management System (QMS), including development and maintenance of documentation
• Commit to fostering and driving an environment and work output based on continuous improvement

Required Skills

Minimum

• Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by Bracco Medical Technologies/ACIST Medical Systems
• 5-8 years of experience in product or test development as an individual contributor
• Knowledge of the systems development lifecycle

• Bachelors' degree in Engineering, or other scientific discipline, preferably electrical, mechanical, Control engineering

• Proven background in automated test system development
• Experience in coordinating with external test system development partners preferred.
• Familiarity with electromechanical systems, sensors, control and data acquisition systems development

• Strength in written and verbal communication, judgment, decision making, and critical thinking
• Ability to grow productive, trusting, and open relationships with functional partners
• Strong interpersonal and communication skills
• High degree of organizational skills and high attention to detail
• Ability to handle multiple tasks and prioritize effectively
• Ability to work both independently and as part of a team
• Ability to develop protocols, conduct system tests and write reports
• Strong initiative, high energy, and passion about new technologies

Preferred:

• Graduate degree in Engineering (EE, ME or Systems Engineering) or another scientific discipline.
• 8+ years of manufacturing test experience
• Experience in the Medical Device or other regulated industry and knowledge of FDA QSR
• Good understanding of production test equipment design issues such as user friendliness, serviceability, ruggedness and has implemented and transferred equipment to external suppliers for high-volume manufacturing
• Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical, human factors and software

Other:

• Adheres to all company policies, procedures and business ethics codes and ensures that they are communicated and implemented with the team.

• Ability to travel up to 10% of the time