Senior Engineer - Embedded SW

Working Location: COLORADO, GOLDEN; MASSACHUSETTS, WESTBOROUGH 

Workplace Flexibility: Onsite

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Senior Embedded SW Engineer is responsible for performing all aspects of SW development for medical devices at Olympus including; technical planning, development of design inputs, code implementation, unit testing, code reviews, 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. It will be the responsibility of the Sr Embedded 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 Sr SW Engineer will serve as a core or extended team member on development projects.

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 Qualifications

Required:

• Bachelor’s degree in Computer Science or other electrical engineering degree with relevant job experience.
• Minimum years of related experience: 5 years with BS or 4 years with MS or 0-2 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.)
• Successful track record of developing quality software for embedded devices in an Agile development environment.
• 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.).
• 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.
• Ability to effectively work