Union City, CA 94587 US
Position Title: Systems Engineer
Position Description: Protingent Staffing has an exciting direct-hire opportunity for a Systems Engineer with our client located in Union City, California.
- As Systems Engineer you will 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 electromechanical systems; ending with product and release testing.
- 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 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 relate 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.
- Manage, prioritize and align work activities with project schedules.
- Understand, follow and support Company’s internal 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).
- Bachelor's Degree and 2-5 years of experience in a technical role as a Mechanical or Systems Engineer in the development of an electro-mechanical products, from Conception, through Development, into Production, and then into Field Support
- Medical device experience preferred; autonomous vehicles, defense, or other complex electro-mechanical products.
- Good understanding of DFx (Design for Reliability, Manufacturability, Serviceability)
- Pluses: working directly with customers to operate the product; experience with mechatronic
- Experience in highly regulated industry: Medical device (i.e., experience with ISO 13485 and FDA 21 CFR 820 compliance) preferred; defense industry or other regulated industry (i.e., security products; aerospace; autonomous vehicles)
- Experience with intergration, verification and validation testing, including protocol development, report generation and regression analysis
- 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.
- Direct Hire
- Salary Range: $91k- 129k/yr
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.