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The Interventional Urology Principal Systems Engineer is responsible for leading, defining, and evaluating new product development and existing designs by using a systems approach to ensure all products meet the customer requirements, standards requirements, quality systems and global regulations. This role will support all project initiatives for implantable devices while leading efforts to create and/or modify Standard Operating Procedures. The Systems Engineer is a key member of our product development team.
Job Responsibility:
Drives the architecture, system design, system boundaries and all associated interfaces
Lead overall requirements hierarchy strategy while establishing performance metrics
Foster a culture of innovation, technical rigor, and quality compliance
Provide guidance, coaching, and training to other employees within job area
Ensure adherence to applicable standards such as IEC 60601, ISO 14708, ISO 14971, IEC 62304, and other related AIMD requirements
Provide input to integration planning and test execution across electrical, mechanical, and software
Support the product lifecycle from concept through verification, validation, transfer to manufacturing, and post-market support
Ensure rigorous risk management practices, including hazard analysis and FMEA, are applied to all designs
Establish and advocate for best practices and continuous improvement to mature Systems Engineering knowledge and processes
Collaborate with all functions within R&D, and across the organization to ensure the role of Systems Engineering is understood
Requirements:
Bachelor’s in Electrical Engineering, Software Engineering, or related field
7+ years of engineering experience
Active Implantable medical device system experience
Experience or knowledge of software, analog and digital systems
Systems level design experience with active implantable medical devices, including those that use external programmers
Nice to have:
Master’s degree in related field
What we offer:
Comprehensive medical, dental, and vision insurance plans
Access to company sponsored wellness programs and mental health resources
Paid leave of absence for qualifying events
Generous paid parental leave for both birthing and non-birthing parents
Competitive 401(k) plan with company match that vest immediately
Financial planning services
Corporate discount programs for goods and services
Generous paid time off
Flexible work hours
Flexible work arrangement options
Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events
A supportive work environment where everyone feels valued, and has a sense of belonging
Participate in team-building activities, volunteer opportunities, and company-sponsored events