Ensure HW requirements and algorithms definitions are complete, testable, traceable, and aligned with product and regulatory needs.
Own HW requirements and algorithms requirements traceability throughout the product development lifecycle.
Support architecture, design, and risk management activities through requirements-based engineering.
2. Algorithms Verification & Validation
Own algorithm requirements, performance specifications, acceptance criteria, and traceability throughout the product lifecycle.
Lead development of proprietary algorithms supporting product functionality and differentiation.
Establish methodologies for algorithm verification, validation, and performance characterization.
Oversee Proof-of-Design activities demonstrating technical feasibility and performance.
Support intellectual property generation and innovation initiatives.
3. Systems Modeling & Simulation
Lead development of system models and simulations supporting design decisions and proof-of-concept evaluations.
Establish methodologies for predictive analysis and system performance assessment.
Leverage simulation results to support requirements development, risk analyses, and design optimization.
Support architecture trade-off analyses through data-driven modeling approaches.
Incorporate best practices and AI as appropriate
4. Hardware-Software Integration
Define system integration strategies for hardware and software subsystems.
Lead integration planning, execution, and issue resolution activities.
Ensure subsystem interfaces are clearly defined and verified.
Support early identification and mitigation of integration risks.
Drive resolution of cross-functional integration issues and interface-related risks.
5. Team Leadership & Cross-Functional Collaboration
Lead, develop, and mentor a team of Systems Engineers.
Build organizational capability through coaching, mentoring, performance management, and career development of team members.
Serve as Agile Product Owner, managing team priorities, backlog, and sprint objectives.
Collaborate closely with R&D, Quality, Regulatory Affairs, Clinical, and Program Management teams.
Ensure alignment between requirements, design outputs, verification activities, and project goals.
Drive a culture of technical excellence, accountability, innovation, and continuous improvement.
6. General
Communicates business related issues and opportunities with management
Follows all applicable procedures and guidelines
Ensure that direct reports follow all applicable procedures and guidelines
Performs other duties assigned as needed by management.
QUALIFICATIONS
Advanced degree (M.Sc. or Ph.D.) in Engineering, Physics, Applied Mathematics, Computer Science, or related field preferred.
Experience developing signal-processing, control, imaging, data-analysis, or optimization algorithms.
Experience with modelling and simulation environments.
Strong statistical and analytical skills.
Experience translating clinical or user needs into quantitative performance requirements..
Strong understanding of Design Controls, IEC 62304, IEC 60601, ISO 14971 and applicable medical device regulations.
Experience working in Agile and hybrid product development environments.
Minimum of 8 years of experience as Systems, Integration, Hardware, Software, Mechanical or Biomedical engineer
Minimum of 3 years of Systems Engineering experience in a medical device company
Previous leadership, project leadership, or people management experience (including military experience) – advantage
Development in Agile environments – advantage
Proven ability to develop timely and effective solutions for challenging design problems
Experience with requirements management and traceability tools and methodologies.
Familiarity with Quality Management System, design controls and risk management in regulated environments and medical devices.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
