Principal R&D Software Engineer

Job Description

The Principal SW Engineer is responsible for performing and/or leading all aspects of SW development for medical devices at Olympus including; technical planning, development of design inputs, code implementation, configuration management, working with 3rd party developers to ensure their designs meet the Olympus quality standards, ensuring that SW development aligns to internal SOPs and IEC 62304, and working across departments to resolve issues. In particular, it will be the responsibility of the Principal SW Engineer to ensure well defined product and performance specifications for the SW are defined and mapped to applicable and appropriate test cases and ensure all efforts are completed on schedule, while proactively mitigating potential issues, to enable the timely launch of high quality / reliable products. He or she must fully understand medical device design control requirements and be able to provide effective technical leadership to product development efforts and team members, negotiate strategies with cross-functional leaders, and work collaboratively across the organization. The Principal SW Engineer will serve as a core or extended team member on development projects. As the Principal SW Engineer will heavily contribute to Design History Files, maintaining detailed documentation throughout all phases of research and development is essential.

Job Duties

* Provides SW leadership on product development projects and/or technology development efforts.

* Accountable for all aspects of SW development activities and associated Design History Files, such as; requirements creation and documentation, architecture and design documents, code generation, configuration management, compliance with coding standards, sw verification and validation strategies, code reviews, etc..

* Capable of leading & developing all SW deliverables required to document a product design and establish compliance with Design Inputs with appropriate specificity and quality.

* Develops engineering solutions and innovations, collaborates with Olympus IP Attorneys as needed.

* Ideates, evaluates, and directs team towards preferred design options which will meet product/performance requirements, cost targets, and manufacturability requirements.

* Maintains a deep understanding of IEC 62304.

* Partners with the electrical engineers to define processor and memory requirements.

* Works closely with the SW test engineering team to ensure testability of the code/product.

* Ensures user requirements are thoroughly traced to test cases where applicable.

* Consults with the Sales, Marketing, and clinicians to define and specify product user requirements and ensures product and performance specifications are appropriate and accurate.

* Manages / directs internal and external design partners, suppliers and manufacturers as needed.

* Leads / plans testing to support marketing collateral, training programs, and launch activities.

* Provides regular updates to engineering and marketing leadership on product status and advancement.

* Supports engineering leadership as required.

* All additional duties as directed.

Job Requirements

REQUIRED QUALIFICATIONS:

* Bachelor’s degree in Computer Science. Electrical Engineering (Electrical or Biomedical / Mechanical with electrical experience preferred), or Mechanical Engineering will be acceptable if worked as a SW engineer for a minimum of 9 years.

* Minimum years of related experience: 9 years with BS or 8 years with MS or 5 with PhD of experience as a SW Engineer.

* Established track record of leading SW development for Medical using Agile Scrum Methodology.

* Experience with C, C++, python, java, or other SW programming languages.

* Knowledge of Atlassian tools (Bitbucket, Confluence, etc.)

* Extensive knowledge of different processor families including experience developing software on ARM processors.

* Extensive working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.).

PREFERRED QUALIFICATIONS:

* Capable of leading & developing all Design Control deliverables required to document a software design and establish compliance with Design Inputs with appropriate specificity and quality.

* Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc.; schematics, selection of components, and current knowledge of developments in the electronics industry.

* Capable of identifying design / performance issues or concerns early in a program and proactively implementing contingency plans and/or planning for mitigations (e.g., electromagnetic compatibility).

* Ability to effectively work within a requirements management system, such as Doors, JAMA, etc and perform hardware risk analyses and hardware DFMEAs. Ability to effectively work within a requirements management system (e.g., JAMA, Doors) and ensure all requirements are appropriately translated into concise / articulate requirements and mapped to test cases.

* Experienced in software risk management efforts; Risk Analyses, DFMEA’s, etc. Experienced in solving challenging and/or ambiguous engineering problems with scientific logic and problem-solving skills. Ability to communicate complex technical concepts clearly and concisely.

* Experienced in applying good judgement and making timely decisions while considerate of technical/business risks in a variety of situations.

* Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.

* Must have a positive attitude and capable of motivating teams / team members to accomplish efforts in a timely manner and with high quality.

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