Associate Manager - Systems Engineering & Algorithms

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Associate Manager, Systems Engineering & Algorithms leads a multidisciplinary team of Systems Engineers responsible for system modeling and simulation, algorithm development, hardware-software integration, and proof-of-design activities. The role owns system hardware requirements, algorithm requirements, integration strategies, and validation of algorithmic performance throughout the product development lifecycle. The Associate Manager drives adoption of modern systems engineering methodologies, model-based and data-driven engineering practices, and AI-enabled development tools while fostering cross-functional collaboration. As Agile Product Owner, this individual ensures alignment between product requirements, technical solutions, regulatory expectations, and business objectives.

RESPONSIBILITIES

1.      Systems Engineering & Algorithms Management

·       Lead the definition, development, and maintenance of system and hardware requirements.

·       Establish and drive algorithms development methodologies, processes, and best practices.

·       Establish and maintain HW requirements, including reviews, approvals, change management, and traceability.

·       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.

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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.