Description for Principal Systems Engineer:
Principal Systems Engineerwill be part of a small, agile team responsible for medical device development projects starting from technology exploration, product definition, to guiding integration with software-controlled electro-mechanical systems ending with product and release testing.
Will contribute to the development of a broad spectrum of products from sterile disposables to complex capital equipment using a customer-centric, collaborative, innovation-driven approach. We value ownership, calculated risk and tolerance for ambiguity as we build future devices and improve existing products.
Responsibilities for Principal Systems Engineer:
- Create innovative solutions to address user needs in products that differentiate the company in the market.
- Translate customer needs into requirements and engineering specifications. Document design input & output.
- Meld technical contributors into a unified team and collaborate to determine the best technologies for the product.
- Develop, manage, and maintain design history files and related deliverables.
- Develop, maintain, and execute to plans, milestones, schedules, and task lists.
- Manage and logically organize data to identify and describe problems and assess the suitability and quality of technical solutions.
- Maintain up-to-date knowledge of medical devices, technologies, and regulatory landscape related to the company’s products.
- Perform complaint, failure, and risk management activities, develop mitigation and risk control strategies and generate supporting documentation.
- Perform engineering, integration, verification, and validation testing, including protocol development, report generation, and regression analysis.
- Develop and document processes, methods, and tools for product testing and evaluation.
- Support cross-functional Design Transfer process to ensure product designs manufacturable & serviceable.
- Support product sustaining activities including value engineering, reliability improvements, manufacturability improvements, field issues with technical and impact analysis.
- Share and provide technical expertise and guidance to other engineers and designers.
- More senior-level engineers may lead projects and teams as assigned.
- Manage, prioritize, and align work activities with project schedules.
- Understand, follow and support company Quality System policies, procedures, and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).
Requirements for Principal Systems Engineer:
- Bachelor's Degree with 8- 12 years of relevant experience, or a master’s degree and 6 years of relevant experience.
- Strong analytical skills and ability to apply engineering principles using logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to comprehend an extensive variety of technical instructions in mathematical and/or diagrammatic form and translate that into design requirement and/or performance.
- Ability to find creative or innovative solutions for design of products.
- Solid understanding of systems engineering principles and methods, system modeling and transformation applications.
- Ability to make and communicate decisions in a timely fashion; to formulate and execute a course of action.
- Ability to independently manage and prioritize work based on goals and objectives and provide deliverables in alignment with timelines and deadlines.
- Ability to adjust to changing timelines and priorities in a fast-paced environment.
- Ability to collaborate cross-functionally and cross-organizationally and respond to the needs of internal customers.
- Strong interpersonal and communication skills and ability to effectively work in a team.
- Excellent written & verbal English communication skills and strong presentation skills.
- Adept use of Office Applications like MS Outlook, Excel, Word, PowerPoint, Visio and Project.
- Familiarity with Engineering Applications like MatLab, LabView or EA.