Sr. Engineer, Systems - Defined Term
GetingeAbout the role
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
We are seeking a highly detail-oriented and systems-minded engineer to serve as the final check for all Systems Engineering deliverables. This role ensures that documentation, traceability, and technical content meet the highest standards of quality, consistency, and compliance with design control requirements. The ideal candidate will thrive in a collaborative environment, bring precision and speed to their work, and maintain a growth mindset—even when not all feedback is implemented.
Job Responsibilities and Essential Duties
- 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.
Minimum Requirements
- 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.
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Required Knowledge, Skills, and Abilities
- 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.
This is a “Defined Term” assignment that will last approximately 12 months or until project is complete. Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.
Salary Range: $115,000 - $125,000 Annually
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