Staff R&D Engineer
In this role, you have the opportunity to:
This is an exciting opportunity to work on New Product Development initiatives as an innovator for next generation diagnostic disposable devices (Imaging Catheters), used in coronary vascular and/or peripheral vascular applications. The Staff Engineer will design & develop primarily in the area of mechanical engineering, but will also engage in transducer design & development, manufacturing engineering, test method development & execution, Verification & Validation documentation & execution, customer interaction, and cross-functional interaction & cooperation (Collaborating with Quality Engineering, Marketing, Clinical Affairs, Regulatory Affairs, etc.)
You are responsible for:
- Lead and support R&D development projects for diagnostic disposable devices
- Design devices via user requirements, biocompatible materials, safety requirements and performance standards
- Create SolidWorks 3D models and generate part and assembly 2D drawings
- Develop fixtures and early-stage manufacturing and assembly processes
- Build physical prototypes of new designs
- Develop fixtures and write protocols/reports for in vitro bench testing
- Perform data analysis on results generated from engineering studies and utilize this analysis to draw meaningful conclusions
- Identify and analyze root causes for failure modes based on test results
- Develop and perform action plans to address CAPA, complaint reduction and other internal projects
- Lead, generate and conduct formal verification and validation plans for completed designs, interacting with Quality and Regulatory staff
- Actively participate in the transfer of designs from R&D to Manufacturing.
- Conduct technical design reviews with the project team(s) and independent subject matter experts across the company
- Follow good practices to document and protect company intellectual property.
- Share best practices across the organization and coach / mentor other engineers and technicians
- Assume full responsibility for assigned designs and effectively supervise work of technicians and operators who contribute to the design
- May have 1-2 direct reports at the technician/operator level (though not primary responsibility)
- Perform as a core team member on cross-functional teams and collaborate with external entities for development
You are a part of:
You will be an integral part of a talented R&D team striving to create the next generation of IVUS Imaging catheter devices that are capable of achieving high levels of performance and provide meaningful value to the customer.
To succeed in this role, you should have the following skills and experience
- Minimum of Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or other relevant field.
- Minimum of 8 years of relevant work experience with a BS or a minimum of 6 years of relevant work experience with an MS
- Ability to read and interpret engineering specifications, drawings, manufacturing instructions and technical analyses
- Ability to design, prescribe, and perform testing of disposable devices involving measurement, tensile strength, simulated use and other methodologies
- Ability to understand and use electro-mechanical machinery and test equipment
- Understanding of clinical relevance and importance of customer requirements with devices used in interventional procedures
- Ability to lead initiatives with regards to technological improvements
- Experience with design control requirements and DHF management
- Strong ability to write technical documents such as manufacturing instructions, mechanical drawings, policy manuals, safety rules, operating and maintenance instructions, and procedure manuals; ability to write routine reports and correspondence
- Strong computer skills with knowledge of Microsoft Windows, Office, Excel, Word, PowerPoint and a statistical package such as Minitab
- Proficiency with 3D modeling and CAD software such as SolidWorks
- Knowledge of descriptive statistical data analysis techniques
- Strong rational and analytical approach to troubleshooting complex systems
- Ability to communicate effectively both orally and in writing
- Ability to establish and maintain working relationships with persons contacted in the course of performing assigned duties including company management and external business associates
- Ability to work in a team environment and prioritizes fostering of cooperative & productive working relationships with colleagues
- Ability to organize and prioritize workflow in order to meet project timelines
- Ability to manage multiple tasks simultaneously
- Self-motivated with ability to work independently or with minimal supervision
- Would not be expected to travel often, could be up to 25% as-needed
- Experience with cardiovascular catheter development and manufacturing
- Experience with IVUS technology
- Experience with transducer development and manufacturing
- Knowledge of inferential statistical data analysis techniques
- Experience with FDA and ISO standards for medical device design controls and manufacturing
- Familiar with improvement methodologies such as Lean, Six Sigma, Design for Excellence, etc.
- Experience with technical presentations to large groups of people
- Previous mentorship and/or team-leadership for junior technical colleagues
In return, we offer you:
An opportunity to drive technically challenging/ engaging projects within our dynamic organization. As a market-driven company, we are accustomed to listening to our customers & apply the same thinking to our employees. We offer a competitive salary, outstanding benefits and flexibility in a career with a positive and supportive atmosphere in which to develop your talents further.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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