Principal Systems Engineer

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Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on Med Tech, we take clients’
Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

Responsible for ensuring translation of user, caregiver, and other various stakeholders’ needs into clearly defined, verifiable design inputs. Leads and collaborates across multi-disciplinary project teams 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.

• 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 drive execution of the 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.

• 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.

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.

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Full-time

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