Sr Systems Engineer

Responsible for delivering consulting services across a range of programs, including safety risk management, verification/validation, and regulatory support.

Job Requirements:

• Bachelor's degree in electrical, mechanical, biomedical, or computer science engineering (or related field).
• 7+ years of relevant experience in an interdisciplinary product development environment.
• Willingness to travel up to 25%, project-dependent.
• Candidates located in or willing to relocate to the Columbus area preferred.

Preferred Skills:

• Experience with regulatory strategies and submissions.
• Knowledge of compliance engineering standards (e.g., IEC 60601-1, IEC 62304).
• Experience with third-party testing coordination (e.g., biocompatibility, environmental testing).
• Familiarity with software and cybersecurity efforts, including planning, risk management, and issue tracking.
• Experience in manufacturing process development and validation.
• Expertise in Computer Software Assurance/Validation.

Job Responsibilities:

• Lead programs of varying sizes and complexities across different sectors.
• Develop and review project requirements with stakeholders.
• Plan and lead safety risk management discussions and assessments.
• Author and execute verification and validation plans, protocols, and reports.
• Participate in design review meetings to ensure project alignment.
• Manage program planning, task management, and ensure adherence to timelines and budgets.
• Provide training and mentoring for junior staff.
• Identify new areas of support for client projects and provide input on business development activities.
• Track project time and maintain compliance with internal processes and core values.

Pay Details: $40.00 to $60.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance