Sustaining Engineer R&D Software
The R&D Engineer in our Sustaining Engineering department is responsible for providing medical device design engineering support in the sustaining of commercially released medical device products, specifically neuro-technology products utilized at the initial point of care. This is a unique opportunity to work cross-functionally on projects of varying scope across the various stages of the product life cycle.
As a Sustaining R&D Engineer, your primary responsibility is design ownership of commercially released products. The design owner uses design control and risk management process along with engineering first principals associated with the design change process to ensure that proposed changes to launched product are systematically and thoroughly analyzed. Additional responsibilities include proposing changes or enhancements to improve overall product design and performance.
- Located in Bethesda, MD
- Competitive salary, excellent stock option package and strong benefits
- The sustaining function has the primary responsibility for protecting the design intent of launched product to meet all safety, efficacy, regulatory, and business performance requirements.
- Researching, planning, evaluating/testing and drawing conclusions to support recommendations for or against changes that assure design and performance intent are preserved. Typical sources of design evaluations are: improved product safety, quality, and/or regulatory compliance
- Ensure manufacturing continuity
- Provides technical and project support for portfolio expansion (line extension) or sustaining-focused projects.
- Develops and controls prototypes throughout software testing, analysis, design refinement and associated documentation.
- Critically review the device software to identify usability and sustainability enhancements. Design and implement approved updates.
- Participates in the remediation of product Design History Files to ensure compliance to standards.
- Learns/understands clinical application of products to aid in failure investigation for fielded and returned products.
- Bachelor's or Master's Degree in Computer Engineering or equivalent required
- Minimum 5-7 years of experience in the development of software for medical devices including experience in sustaining or manufacturing engineering
- Design Control/Design Change process experience, including working knowledge of the SDLC conforming to the IEC 62304 medical device software standard, utilizing CMMI and common software development models
- Experience with software development and testing employing the following technologies: Android OS, Android SDK and NDK, Linux, Java, C/C++, SQL, Python, and RESTful interfaces
- Design, development, and troubleshooting of embedded computer systems, data acquisition platforms, digital systems and circuits
- Strong statistical analysis and data analysis skills and experience
- Some travel to contract manufacturer to support production build may be required
- Strong technical leadership skills with a track record of identifying, evaluating and solving complex technical problems
- Ability to communicate in a clear and concise manner, whether verbally or in writing
- Operate effectively in a multi-disciplinary, team-oriented culture that emphasizes professional development.
- Comfortable working in a fast-paced start up environment
- Strong problem solving skills
- Familiarity with embedded software stacks and ARM processors
- Experience creating and scripting automated software tests to investigate and evaluate software related failures
- Experience working on cross-functional, cross-site, and cross-cultural teams
- Ability to manage multiple tasks/projects
- Familiarity with the failure analysis process and experience utilizing systematic tools such as Is / Is not and Fishbone
- Documentation management
- Working knowledge and familiarity with the IS0-14971 Risk management process
- US and International Regulatory Standards Requirements
- Strong communication skills with experience communicating to several layers of management
- A track record of accomplishment and innovation in driving multiple manufacturing programs or processes
Quality System Requirements
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
Qualified applicants are encouraged to send their resume and a cover letter including availability to firstname.lastname@example.org.
The Office of Federal Contract Compliance Programs (OFCCP) has released a Voluntary Self-Identification Form CC-305. All federal contractors are required to use this form in inviting all applicants and employees to provide information regarding their disability status. Completing this form is voluntary and any answer you give will be kept private and will not be used against you in any way. If you choose to complete the form, please attach it with your job application. The form can be found at https://www.dol.gov/ofccp/regs/compliance/sec503/Self_ID_Forms/VoluntarySelf-ID_CC-305_ENG_JRF_QA_508c.pdf