Description

JOB DESCRIPTION

The Software Validation Engineering Intern will contribute to ensuring the safety, effectiveness, and compliance of our medical device software throughout the design and development lifecycle. This position will be involved with maintaining robust quality management systems, participating in software design control activities, and collaborating with internal and external cross-functional teams to deliver cutting-edge medical solutions.

RESPONSIBILITIES

The Software Validation Engineering Intern will be an in-person role with a reporting structure into Trumbull, Connecticut and will be responsible for providing software design and implementation support for Quality Engineering in New Product Development and Sustaining projects. This position will provide support in generating quality engineering deliverables to support software development and validation. This individual will be expected to apply his/her knowledge of software and medical devices to positively influence software development efforts as needed.

Essential Functions & Accountabilities:

• Be a representative to the Quality function on product/process/software development teams.
• Review and understand software systems in order to participate in Risk Analysis activities.
• Lead or participate in investigating and documenting possible failure modes of software systems and propose requirements or testing as controls.
• Develop knowledge of current regulatory requirements and standards as they pertain to the software development and release of medical devices & software.
• Lead or Participate in the investigation of complex product & software problems. Identify and manage corrective actions resulting from problem investigations.
• Participate in reviews for System, Software, and cybersecurity requirements, Software and Firmware design, and code inspection
• Identifies and documents risk throughout the development process with the use of FMEAs and/or other risk management tools. This includes leading the Risk management efforts of the software design process and working with design team and management team on managing product, process, and cybersecurity risks.
• Creation, evaluation, and validation of software, product and process test methods.
• Contributes to software design input requirements from experience with previously reported problems, Cooper's products, competitive devices and/or other similar products.
• Comply with applicable FDA and international regulatory laws/standards and the Cooper's Code of Conduct.
• Other duties as assigned or required.

QUALIFICATIONS

Knowledge, Skills and Abilities:

• Medical Devices Experience, including Software in a Medical Device and/or Software as a Medical Device. Experience with embedded systems is preferred.
• Ability to read and understand highly technical material.
• Intermediate skill in the use of Excel, Word and PowerPoint. Advanced preferred.
• Proficient in reading and writing in English
• Self-motivated and committed to a team approach
• Strong interpersonal, organizational and project management skills
• Strong oral, presentation and technical writing skills
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving skills with acute attention to detail.

Experience:

• Preferred experience working with embedded systems.
• Preferred experience in medical devices, with knowledge in women's health is preferred.

Education:

• Current college student entering their Senior year.
• Computer Engineering, Biomedical Engineering, or Computer Science Engineering majors
• Minimum 3.0 GPA

CooperSurgical is an equal employment opportunity employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran

ABOUT US

The Software Validation Engineering Intern will contribute to ensuring the safety, effectiveness, and compliance of our medical device software throughout the design and development lifecycle. This position will be involved with maintaining robust quality management systems, participating in software design control activities, and collaborating with internal and external cross-functional teams to deliver cutting-edge medical solutions.