PENTAX Medical · 1 week ago

Senior Embedded Software Engineer

Montvale, NJ

Full-time

Remote

Senior Level

5+ years exp

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Responsibilities

Embed programing of medical device products from concept to implementation while ensuring full documentation of the process.

Develop embedded, real-time software for Pentax Medical embedded products. Systemically design, develop and implement high-quality software in C, C++ and include implementation of various types of algorithms and GUI elements.

Analyze cases and document software requirements specifications and software design documents. Obtain feedback and cross-functional approval of documents.

Conduct code-review for individual and collaborative software.

Investigate new technologies for medical device utilization.

Define, plan, and conduct formal technical design and test reviews.

Lead and apply risk management tools including risk matrix, risk impact/probability charts, FMEA, PFMEA, to software.

Guide, develop, and review software verification strategies to test designs.

Effectively communicate and work with all levels of the organization.

Multi-task and prioritize work based on the shifting needs of the organization.

Leverage appropriate tools such as MS PowerPoint and Project to communicate, plan, implement, and track projects.

Qualification

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Embedded Code DevelopmentTechnical DocumentationRegulatory ComplianceElectro-Mechanical SystemsMedical Devices IndustryProject ManagementSoftware DevelopmentProblem-SolvingCommunicationWork Under PressureWith class II medical devicesWithin medical device space

Required

Bachelor’s degree in Electrical Engineering or Computer Science with at least 5 years of work experience, OR Master’s degree in Electrical and at least 3 years of technical engineering professional experience

Demonstrated experience writing, documenting, troubleshooting, and releasing embedded code. Experience developing code for mid-to-large embedded or real-time applications, with responsibility for designing and implementing solutions that are currently in commercial use

Demonstrated problem-solving skills – ability to analyze issues, design requirements and propose solid engineering solutions that meet business requirements

Ability to generate technical documentation such as product requirements, specifications, risk matrix, project schedules, engineering reports, test plans & procedures, validation plans, or validation reports

Experience developing products in a highly regulated industry such as medical devices. Experience within the medical device space highly desirable. Experience with a class II medical devices also highly desirable

Demonstrated experience with complex electro-mechanical systems

Good written and communication skills

Demonstrated ability of working on multiple simultaneous projects in a deadline-driven matrix environment

Ability to develop a plan, come up with realistic schedules and meet timelines for software development

Adheres to safety and regulatory policy and procedures