About This Role

Responsible for ensuring translation of user, caregiver, and other various stakeholders’ needs in clearly defined, verifiable design inputs. Leads and collaborate across multi-disciplinary project team to define system solutions, architectures, and interfaces, assess business and technical tradeoffs and risks, and provide technical leadership to ensure system and subsystems adequately meet the design inputs.

What You Will Do

• Lead technical direction of projects through execution and delegation of systems engineering tasks.
• Guide project teams to identify and develop design input requirements.
• Provide technical oversight and independent review for cross-functional development teams.
• Collaborate with user research specialists to gather and prioritize stakeholder needs.
• Mentor and train systems engineering staff, supporting team-building activities.
• Investigate and implement tools to improve quality and efficiency.
• Support business development by participating in client meetings and contributing to proposals.
• Lead multi-disciplinary teams and programs through system definition and associated product development processes and activities.
• Lead systems engineering efforts and drives execution of development strategy related to systems engineering deliverables.
• Communicate and collaborate with internal and external subject matter experts (SMEs) to facilitate technically sound execution of programmatic deliverables.
• Translate early research findings, business and user needs, and regulatory requirements into functional requirements with documented rationales, intended to be measurable and verifiable or validated at later stages.
• Capture and facilitate the evolution and ultimate systems design output, rationales, and lower-level requirements associated with final design.
• Work with clients to gather and prioritize business needs, assumptions, requirements, and pre-defined design constraints.

Required Qualifications

• 5-8 years of relevant work experience
• Bachelor’s degree in engineering or related discipline
• Medical Device Experience required
• Strong knowledge of systems engineering principles and medical device product development lifecycle, including verification and validation
• Familiarity with regulatory requirements (FDA, IEC 60601, ISO 14971) and design control processes.
• Excellent written and oral communication skills.