
Sr. Engineer, Systems - Defined Term
- Wayne, NJ
- $115,000-125,000 per year
- Permanent
- Full-time
- Deliverable Review: Serve as the final reviewer for all Systems Engineering outputs, including requirements documents, trace matrices, risk files, and verification protocols.
- Design Control Compliance: Ensure all documentation aligns with 21 CFR 820.30, ISO 13485, and internal design control procedures.
- Traceability & Consistency: Validate that system-level requirements are clearly defined and consistently linked across the design history file (DHF).
- Quality Gatekeeping: Identify gaps, inconsistencies, or ambiguities in technical content and work with authors to resolve them prior to release.
- Documentation Standards: Maintain and apply document standards, templates, and best practices to ensure clarity, completeness, and usability.
- QMS Submission Support: Prepare and finalize documentation as needed to support Quality Management System submissions, ensuring readiness for audits and regulatory reviews.
- Education: Bachelor's degree in Systems Engineering, Biomedical Engineering, or a related technical field.
- Advanced degree preferred.
- Strong desire to learn design control processes and documentation requirements.
- Excellent written and verbal communication skills.
- Strong organizational and time management abilities.
- Collaborative mindset with the ability to work independently and cross-functionally.
- Precision & Speed: You are quick and meticulous, with a sharp eye for detail and a commitment to getting things right the first time.
- Collaborative Spirit: You work well with others, offering constructive feedback and supporting team goals.
- Resilient Contributor: You understand that not all feedback will be implemented, and you remain engaged and solution-focused regardless.
- Growth-Oriented: You seek opportunities to improve your own understanding of systems engineering and design controls, and you value learning through dialogue and iteration.
- Ownership & Clarity: You take pride in maintaining solid, well-reasoned rationale for every decision and recommendation you make.
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits