Systems Engineer I

Quick Facts

Systems Engineer I role focused on systems engineering and requirements management for medical technology.

Description

Translate customer and clinical needs into clear, actionable product requirements and system architectures. Lead requirements management to ensure traceability from requirements through verification and validation, while collaborating with cross-functional engineering, marketing, and clinical teams. Support verification and validation planning, participate in design validation, and assist with pre-clinical and clinical evaluations for effectiveness and safety.

Responsibilities

• Translate customer and clinical needs into product requirements and system architectures
• Lead requirements management with traceability from requirements to verification and validation
• Collaborate cross-functionally to drive technical excellence
• Contribute to system architecture and design decisions balancing clinical benefit and technical feasibility
• Support verification and validation planning and participate in design validation activities
• Assist with pre-clinical and clinical evaluations to ensure product effectiveness and safety
• Continuously develop systems engineering expertise and contribute to process improvements

Requirements

• Bachelor’s degree in Biomedical, Electrical, Mechanical, Computer Engineering, or a related scientific field
• 0–2 years systems engineering and requirements management experience with a bachelor’s degree, or 1 year with a master’s degree
• Understanding of design control within a regulated medical device environment
• Experience or exposure to hardware/software systems and requirements management tools such as DOORS or JAMA
• Strong collaboration skills in a matrixed environment
• Excellent communication skills with stakeholders at multiple levels
• Self-motivated and driven to make a meaningful impact
• This position does not offer visa sponsorship now or in the future

Benefits

• 401k Matching Program and 401k Plus Program
• Discounted Stock Options
• Tuition Reimbursement
• Flexible personal/vacation time off, paid holidays, flex holidays, paid community service day
• Medical, Dental, Vision, Health Savings Account (employer contribution of $500+ annually)
• Employee Assistance Program
• Parental leave
• Fertility and adoption assistance
• Hands-on, team-customized training and mentorship
• Fitness club and travel discounts