Location: Warrendale,PA, USA
Job Summary
The Senior Engineer performs software development and software validation tasks of creating automated manufacturing test fixtures used in the assembly and testing of medical devices. This includes creating software requirements, software design documentation, performing code reviews, writing and executing test cases, investigating and resolving software bugs, and implementation. This position also requires the selection of appropriate techniques to solve problems and make design recommendations under the direction of a supervisor. Requires working in a team environment with cross-functional team members, such as manufacturing, quality, regulatory, and other R&D departments. This position reports to a Sr. Principal Engineer or above and has no supervisory responsibilities.
Responsibilities
* Performs software engineering tasks such as Design, Development, Integration Testing, Debugging and Root Cause Analysis as required to meet the product requirements and business objectives.
* Utilize engineering principles, technical analysis, computational analysis, and problem-solving tools to resolve technical problems and quality issues.
* Participates in the development, deployment, and life-cycle management of automation tools used in the manufacturing of medical devices.
* Support other departments with designing test fixtures and other requests.
This job position within the MedTech division of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).
REQUIREMENTS
* Bachelors degree in Computer Science and/or Engineering degree with 3-5 years of relevant experience in automated test fixtures.
* Experience with design and development of software-controled electromechanical systems using Python and other types of automated software.
* Familiar with appropriate FDA QSR and ISO regulations: design controls, document controls, design verification and validation.
* Proficiency in Python.
* Must possess a firm foundation in the basic principles of their respective engineering discipline.
* Able to manage projects, coordinate contractors, and direct the activities of a technician.
* Excellent verbal and written communication skills.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.