System Engineer, Staff

Siemens - Greater Boston Area

Posted 616 days ago
  • Experience
    Mid-Senior level
  • Job function
  • Employment type
  • Industry
    Medical Devices
  • Job ID
  • Committed to hiring veterans

This is a preview of the System Engineer, Staff job at Siemens. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

About this job

Job description

The Systems / Sustaining Engineer develops and supports systems for in vitro diagnostic (IVD) instruments and accompanying laboratory automation. These medical devices provide rapid diagnostic testing for clinical laboratories for a wide range of diseases and other clinical applications

Responsibilities of the position may include:

• Lead cross-functional engineering teams (mechanical, electrical, chemical, software) utilizing project management skills.

• Translate customers’ and business needs into engineering requirements.
• Interpret and allocate System level requirements into Subsystem level requirements, ensuring complete traceability.

• Perform system modeling and analysis

Risk Analysis
• Perform safety risk analysis to assure the safety and efficacy of the device.
• Perform technical/functional risk analysis to uncover engineering and project risks.

Problem Solving
• Design, plan and execute laboratory experiments to evaluate feasibility of concepts.
• Solve complex technical issues by troubleshooting, determining root cause, and then proposing design modifications.

Verification and Validation
• Write verification and validation plans and protocols to effectively test designs against requirements and customer needs.
• Perform or oversee the execution of verification and validation testing.
• Review test data against established pass criteria.
• Write clear, data-driven technical summaries and test reports.

Manufacturing and Customer Support
• Transfer designs to manufacturing facilities and support scale up.
• Provide engineering support for product launches and continued customer usage.
• Resolve escalated manufacturing support projects
• Interface with vendors to resolve incoming quality issues.
• Lead global product support teams
• Represent CPE on Core Teams to plan for transition from Development to post launch support.
Desired Skills & Experience
Required Skills:
• Strong verbal and written communication skills
• Analyze complex multi-variable situations; develop, implement and verify solutions
• Bias towards hands on troubleshooting
• Operate flexibly in an environment with competing priorities
• Excellent problem identification and innovative thinking skills to design experiments, assess risks, develop solutions and determine verification and validation requirements.
• Able to lead and influence small focused development or problem-solving teams
• Able to lead, team with, and influence cross-functional and cross-site teams.
• Strong Project Management skills
• Strong Process Engineering, Process Design, and Process Control skills
• Decision making using basic statistical techniques and DOE – Six Sigma Certification preferred
• Exhibits a bias toward action, balanced by strong analytical decision-making skills

• BS/MS in Engineering or Science w/ 10+ years experience
• Experienced in Manufacturing Engineering, Sustaining Engineering, or Product Development
• Problem solving and change management in a regulated environment (desired)

The successful candidate will have a strong understanding of engineering fundamentals and how they can be applied across engineering, chemistry, and software disciplines, as well as an appreciation for the regulated medical device industry. He/she will be able to perform systems thinking (big picture view). An understanding of electro-mechanical, precision fluidic handling, and software-controlled systems is critical, and experience with assay/method development is a plus. The individual must function well both independently and as part of an integrated team. Effective verbal and written communication skills are essential. Familiarity with instrument manufacturing processes is helpful. Experience with requirements management tools is preferred, as is prior work with prototyping software and data collection tools, and system modeling tools such as finite element analysis.

The ideal background is in systems, biomedical, mechanical, chemical, or electrical engineering, with related experience in requirements, verification and validation. Work experience in the medical device industry or other regulated industry preferred.

About this company

Siemens AG (Berlin and Munich) is a global powerhouse in electronics and electrical engineering, operating in the industry, energy and healthcare sectors.<br>The company has around 430,000 employees (in continuing operations) working to develop and manufacture products, design and install complex systems and projects, and tailor a wide range of solutions for individual requirements.<br>For over 160 years, Siemens has stood for technical achievements, innovation, quality, reliability and internationality.

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