Halyard Health is seeking a highly motivated and experienced R&D Engineer to fulfill a technical leadership role on an emerging R&D team responsible for building a new growth platform within Halyard’s Core Devices franchise. This role is essential in successfully executing product development strategies on a platform of medical electrical devices leveraging newly acquired technology assets.
The role requires a deep knowledge of scientific principles spanning various engineering disciplines in addition to a deep system understanding for supporting the concept, development, and operational lifecycles of legacy and new products. Specifically, this role will oversee the technical aspects in the design and development of embedded medical devices containing custom and off-the-shelf hardware and software components, and having related disposables. The role will provide technical guidance for an interdisciplinary team comprising internal and external developers of various disciplines (Systems, Electronics, Software, Hardware, Mechanical). The preferred candidate possesses strong technical leadership traits and will drive key product development initiatives that result in improving clinical and hospital outcomes. This role requires a passion for detail, a broad technical knowledge of system integrations, and a desire to contribute as a hands-on developer within a growing team.
- Technical leadership role on assignments, supporting program leadership in coordinating and completing technical activities of all engineering disciplines within a project.
- Develop product system designs balancing customer requirements, available technologies and integration constraints, resulting in high-quality, cost-appropriate products.
- Perform analyses of requirements, design, function, integration constraints, risks, hazards, and timelines to translate requirements into consumable, hardware, and software designs.
- Define and guide decision makers, stakeholders, product managers, and engineering organization to capture system requirements, risks, and technical, financial, timeline trade-offs.
- Produce documentation for each development phase of sufficient scope and depth to describe the operational theory of systems and the critical-to-quality design elements.
- Provide multifaceted technical expertise in reviewing product innovation roadmap strategies
- Identify strengths/weaknesses of various approaches for addressing market opportunities
- Establish technical domain knowledge relevant to the business and industry
- Generate & document system, sub-system, and interface requirements based on design inputs
- Manage functional and physical decomposition and traceability of requirements to promote design optimization by engineering teams across several disciplines
- Drive technical design decisions while factoring input and perspectives from team
- Write invention disclosures to protect new designs that provide proprietary advantages
- Drive the development of detailed design specifications and system integrations
- Support development of System and Software Hazard Analyses and Design FMECAs
- Develop and author test plans, test protocols, test methods, and test reports
- Execute product changes through design controls and support creation of Manufacturing/QC procedures for components and sub/systems
- Mentor engineers in engineering activities/methodologies and domain knowledge
- Provide technical support for regulatory product submissions and quality audits
Qualifications & Skills:
- Academic degree (BS/MS) and a minimum of 5 years’ experience in relevant Engineering field (CE, EE, CS, Systems, Physics, etc.)
- Relevant engineeringexperience in the development of safety critical device designs, medical device highly preferred
- Ability to handle a wide range of technical fields (electrical, software, physics)
- Strong understanding of system design and HW/SW integration
- Entrepreneurial spirit that can operate both independently and as part of a team
- Self-motivated with a passion for solving problems employing a hands-on approach
Experiences and Knowledge:
- Leading functional teams on a medical device development project or platform initiative
- cGMPs and applicable medical industry standards
- Integrating software and hardware in an embedded context
- Analog and/or digitalcircuit design preferred
- Microcontroller system design and programming, preferably 8051 & AVR RISC architectures
- Requirements Traceability Management tools and/or relational database management systems preferred
- C/C++ programming skills preferred
- Laboratory test equipment and supplies
- Hospital Information Systems (HIS) connectivity knowledge preferred (HL7, MDIL); (via wireless technology)