We are seeking a highly motivated and experienced Sr. Software Engineer to fill a Principal level technical role on an emerging R&D team. This R&D team will be responsible for building a new growth platform of Intelligent Enteral Feeding Technologies focused on improving clinical and hospital outcomes.
The Senior Principal Engineer will play a key technical leadership role in the development of new medical devices, working cross functionally to define software system architecture and ensuring that stakeholders are aligned, and needs are met. The preferred candidate should possess strong technical traits related to software development, implementation and integration, a deep technical knowledge of scientific principles related to medical devices, and a passion to contribute as a hands-on developer within a growing team.
How you will make an impact:
- As a senior member of the team, you will work with the program leader, cross-functional team leads, and external partners to translate customer and marketing requirements into well-defined product and system specifications which can be successfully verified, validated, and launched.
- Develop and document in coordination with internal and external development partners the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into software and hardware architectures, subsystem specifications, & interface specifications.
- Ensure the systems solutions account for technical, cost and schedule constraints.
- With minimal direction, generate technical documentation such as invention disclosures, formalized use cases, detailed design descriptions, implementation specifications, hazards analyses, engineering study reports, test plans & procedures, validation plans and reports, and related documentation supporting the development of electromechanical devices containing software.
- Perform software/hardware/system module requirement analysis, design, and test design.
- Establish and maintain working knowledge of technology trends and how they are or can be made relevant to our business.
- Generate meaningful metrics to ascertain status, stability, maturity of requirements.
- Perform or oversee system integration testing and troubleshoot technical issues.
- Perform or oversee verification testing against requirements and troubleshoot technical issues
- Develop a close working relationship with colleagues in the sales and marketing organizations to understand the market space and to translate that knowledge to well-crafted product requirements.
- Participate in design and execution of early clinical feasibility studies to better appreciate design / technical trade-offs and use case constraints.
- Develop and maintain strong working relationships with partners in the Quality and Operations organizations to ensure smooth and timely product introductions
- Identify, establish, and advocate for best practices to mature the Systems Engineering knowledge and processes at the company
What you bring to the table:
- BS or MS in Electrical & Computer Engineering, Computer Science, Systems Engineering, or Biomedical Engineering
- 10+ years of experience in systems and software related engineering, highly preferred experience working with regulated medical devices
- Experience analyzing design inputs (voice of the customer, contextual research, etc.) and transforming them into high quality use cases, stakeholder requirements, and system requirements
- Experience generating technical documentation (product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports) while ensuring traceability back to source documents and rationales.
- A demonstrated record of accomplishment in electromechanical product development and working in cross-functional teams.
- Demonstrated ability to get results through others not under direct supervision, including external vendors
- Outstanding communication and presentation skills (written and verbal) to all levels of an organization.
- Flexibility to work both in a Stage gate/Waterfall and an Agile development model environment.
- Detail-oriented with strong organizational, problem solving, and communication skills (both written and oral).
- Ability to be an individual contributor and have a team leader influencing skill set.
- Ability to travel up to 20-25% at times, some international
- Prior hands-on software implementation and integration experience strongly desired.
- Working knowledge of standards related to medical electrical equipment containing safety critical software strongly desired
- Ability to build out a broad working knowledge of multiple software systems including: firmware/embedded systems; SoC platforms; wireless connectivity; device drivers; cloud architectures and web services for collecting device telemetry; data security and encryption for confidential patient information; data analysis and visualization; among other relevant platforms to determine the most appropriate architecture build for multiple generations of new instrumentation and digital health systems.
- Experience leading risk management activities strongly desired (Hazards Analysis, UFMEA, DFMEA, etc.)
- Project management experience strongly desired (understanding cross-functional linkages, etc.)
What’s in it for you:
Our commitment to improving the health and wellbeing of others begins with our employees through a comprehensive and competitive range of benefits. We provide more than just a salary – our Total Rewards package encompasses everything you receive as an employee; your pay, bonus, health care benefits, retirement plans and work/life benefits.
Our perks include:
free onsite gym | onsite cafeteria | 401(k) + 6% match | immediate vesting | benefits on day 1 | uncapped sales commissions | HQ region voted ‘best place to live’ by USA Today
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.