Job Summary
Experienced engineering position, under minimal supervision participates in designing, building and maintaining software used in medical devices and engineering projects related to medical technology. Applies standard engineering practices to resolve problems of mid to high complexity. May assist and mentor less experienced engineers.
Salary Range: $115,000 - $131,000 per year
Position is eligible to participate in a bonus plan with a target of 8% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.
Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.
Responsibilities
This Engineer plans, designs, executes, documents, and analyzes software engineering process automation and/or processes within established medical product design controls. Investigates and recommends new technologies, processes and best practices. Displays a solid understanding of theories/practices utilized by own discipline and other disciplines outside the primary area of expertise to identifies coverage of risks, requirements, architectural components, functions and performance.
Works with senior leadership to improve software engineering process efficiency. Resolves as well as leads others to resolve software automation defects. Performs and reviews root cause and failure analysis activities, as well as identifying causes and mechanisms of system issues identified during testing, and convene design reviews where needed. Defines, supports and administers Linux and Windows based systems that support the needs of the Fresenius-Kabi development and test team. Provides operational support to corporate IT. Develops tools and test automation software used in the verification and/or validation of Fresenius-Kabi products. Assists with Project timing, tracking progress to program schedule. Mentors and guides junior staff. Validates tools used in the development of Fresenius-Kabi products. Organize technical records and files, and ensure that records are indexed, archived, and can be retrieved. Collaborates with software development on the resolution of cybersecurity vulnerabilities Uses computer-based tools to trace tests to requirements, uses cases, or other design documents; updates test documents as design documents change. - Understands regulations, to apply guidance and standards on design verification and design validation to test activities and work products; prepares documentation for compliance with standard operating procedures
Requirements The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Bachelor's degree in Engineering, Information Technology or related field is preferred. * 5+ years of experience in software engineering, troubleshooting and solving problems. * Experience working in the Agile environment a plus. * Experience with cloud based environments such as Azure, AWS and GCP are a plus. * Experience in the software development life-cycle methodology and verification of software product implementation. Experience of medical device development processes and FDA regulations a plus * Ability to work as a collaborative team member. * Strong problem solving and analytical skills * Analysis, troubleshooting, and debugging skills. * Experience working in the virtual environments. Experience with VMWare is desired. * Knowledgeable in source control management and configuration. Experience with Git/Bitbucket desired. * Attention to details, natural inclination to be methodical. * Strong problem solving and analytical skills * Excellent written and verbal 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 contribution, andwellness 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.
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