In this exciting role as a Principal Systems Engineer you will be responsible for leading the development of our new tibial neurostimulator system solutions. You will act as a technical leader working within a matrix organization to support the Systems Engineering organization in the definition design development and testing of complex medical device systems within the Pelvic Health Operating Unit. System designs typically include a mix of consumer and medical technologies involving electronic circuits batteries software wireless communication and supporting network services. Next-generation systems are developed with a user-centered design approach ensuring innovative solutions that meet marketplace needs.

PELVIC HEALTH therapies treat patients suffering from overactive bladder non-obstructive urinary retention and fecal incontinence with sacral neuromodulation and percutaneous tibial neuromodulation devices.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Perform technical planning system design and architecture evaluates alternatives including cost and risk supportability and analyses for total systems.

• Analyses are performed at all levels of total system product to include: concept design fabrication test installation operation maintenance and disposal.

• Define and/or review requirements for implantable medical device systems that meet the expectations and uses of the customer regulatory agencies and the business.

• Ensure the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical schedule and cost constraints.

• Perform functional analysis timeline analysis detail trade studies requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

• Lead technical architecture activities to drive complete system definition establish performance metrics and define system interfaces.

• Perform/participate in Risk Analysis activities such as FMEAs and Hazard Analyses for systems features and implementations with the intent to eliminate or mitigate the risks in the identified scenarios.

• Provide support to customers and clients for Pelvic Health systems during and after launch.

• Identify and resolve product issues both internally during product development and post launch if field issues arise.

• Act as a team leader to manage major / moderately complex projects involving delegation of work and review of work products.

• Provide guidance coaching and training to other employees within job area.

• Establish and advocate for best practices and continuous improvement to mature Systems Engineering knowledge and processes.

• Champion consistent implementation of the Quality System across projects.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies using specialized knowledge and skills.

DIFFERENTIATING FACTORS

• Autonomy:

• Recognized expert managing large projects or processes.

• Exercises considerable latitude in determining deliverables of assignments with limited oversight from manager.

• Coaches reviews and delegates work to lower level specialists.

• Organizational Impact:

• Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group results.

• May manage large projects or processes that span outside of immediate job area.

• Innovation and Complexity:

• Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and investigation.

• Develops solutions to moderately complex problems and/or makes moderate to significant improvements of processes systems or products independently to enhance performance of job area.

• Implements solutions to problems.

• Communication and Influence:

• Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.

• May negotiate with others to reach understanding or agreement and influence decision-making.

• Leadership and Talent Management:

• Typically provides guidance coaching and training to other employees within job area.

• Typically manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.

• Required Knowledge and Experience:

• Requires mastery of a specialty area and full knowledge of industry practices typically obtained through advanced education combined with experience.

• May have broad knowledge of project management.

Must Have: Minimum Requirements

• Requires a Baccalaureate degree

• Minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.

To be considered for this role please ensure the minimum requirements are evident on your resume.

Nice to Have

• Bachelors degree in Computer Science Computer Engineering Biomedical Engineering Electrical Engineering or similar discipline

• Experience in Systems Engineering discipline or use of Systems Engineering methodologies including Systems Modeling Language (SysML)

• Previous medical device experience with a history of developing products from technology to market release in an FDA regulated environment

• Experience with designing for the hardware/software/communication interfaces of electronic devices

• Strong software background with understanding of database structure and using APIs to interface with databases

• Experience working with and designing systems to meet ISO and Quality System Regulation requirements including IECIEC-62304 ISO-14971 FDA 21CFR820.30 for Class I II and III medical systems

• Experience with data privacy (e.g. EU GDPR) regulations

• Demonstrated strong verbal/written communication skills

• Demonstrated ability to make decisions quickly and guide a team through complex problems