Systems Engineer (Medical Device, DHF)
Location: Warsaw, IN
Job Type: Contract
Company: IDR
Category: All Other
Job Description Apply Now
Are you a detail-oriented professional with a passion for regulated medical device development? We are seeking a Systems Engineer (Medical Device, DHF) to join our dynamic team in a full-time, remote capacity. This role plays a critical part in supporting Design History File (DHF) remediation and driving product development within a strict medical device regulatory environment. The Systems Engineer (Medical Device, DHF) will focus on maintaining high standards for documentation, ensure compliance with industry regulations, and collaborate closely with cross-functional teams across Quality, Regulatory, and Engineering departments.
In this position, you will work on integrating legacy documentation into an enterprise Quality Management System (QMS) and design control processes following company acquisition. By leveraging your expertise in system requirements drafting, verification and validation (V&V), and risk management, you will help ensure the safe and effective transfer of design authority and alignment with best practices such as FMEA and ISO 14971.
As a Systems Engineer (Medical Device, DHF), you will be pivotal in ensuring that all system requirements are well-defined, documented, and validated, supporting the continuous improvement of medical devices. This opportunity offers the chance to build your career with a leading organization recognized for its commitment to excellence, employee support, and industry leadership. If you are driven to excel in regulated environments and passionate about making an impact in healthcare technology, we encourage you to apply by clicking the job application button below.
Systems Engineer (Medical Device, DHF) - Summary- Full-time, remote role supporting documentation and compliance in medical device development.
- Key focus on DHF remediation, QMS integration, and design control systems post-acquisition.
- Critical involvement in drafting system requirements and supporting V&V activities.
- Collaborative environment working with Quality, Regulatory, and Engineering teams.
- Support DHF remediation efforts, including integration of legacy documentation into enterprise QMS and design control systems.
- Draft, define, and maintain system requirements based on user needs, ensuring robust support for verification and validation.
- Collaborate with cross-functional teams to ensure seamless documentation updates and regulatory compliance.
- Participate in risk management activities, including FMEA and alignment with ISO 14971 standards.
- Assist in transferring design authority, balancing technical execution with precise documentation.
- Write and revise requirements, test protocols, and technical documentation to support product lifecycle processes.
- Competitive compensation package tailored to experience and expertise.
- Comprehensive benefits including Medical, Dental, Vision, and Life Insurance.
- Employee Stock Ownership Program for long-term financial growth.
- Opportunity to work with an industry leader recognized for employee satisfaction and innovation.
- Minimum 5 years of hands-on experience with Design History File (DHF) processes.
- Prior experience in a Systems Engineer, Systems Designer, or similar design controls role within a regulated environment.
- Strong understanding of design controls, regulated product development, and compliance standards.
- Demonstrated experience in writing requirements, test protocols, and technical documentation.
- Proficiency in verification and validation (V&V) activities.
- Familiarity with risk management tools such as FMEA and knowledge of ISO 14971 is highly desirable.
- Detail-oriented and methodical, with a strong commitment to regulatory compliance and documentation accuracy.
- Collaborative team player who communicates effectively across functional teams.
- Self-motivated and adaptable, comfortable working remotely and managing multiple priorities.
- Keen interest in continuous learning and contributing to the advancement of medical device technology.
- Work remotely while supporting a talented, mission-driven team that values innovation and compliance.
- Join a company with over 25 years of experience and a proven track record in the medical device industry.
- Benefit from a dedicated Engagement Manager committed to your professional success and growth.
- Be part of an organization consistently recognized with industry awards for excellence and employee engagement.
- Experience personal and professional growth as you help shape the quality and safety of life-changing medical devices.
Ready to take the next step in your career as a Systems Engineer (Medical Device, DHF)? Apply today by clicking the job application button and become part of a forward-thinking team dedicated to making a difference in healthcare technology.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. IDR is subject to certain governmental recordkeeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, we invite employees to voluntarily self-identify their race or ethnicity, gender, and veteran status (if applicable). Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information obtained will be kept confidential and may only be used in accordance with the provisions of applicable laws, executive orders, and regulations, including those that require the information to be summarized and reported to the federal government for civil rights enforcement. You may access this form here.