Design Control Engineer/Specialist

Job Description Summary

Job Description Summary
This position is in GE Healthcare's MIM Software business which makes vendor-neutral imaging software to standardize your workflow and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM® to give patients more precise, personalized care.

https://www.mimsoftware.com/

The Design Control Specialist is a detail-oriented and collaborative member of the Quality team. The primary responsibility is to ensure an effective design, development, and transfer process that adheres to applicable FDA, EU regulations, ISO 13485:2016, and other governing regulations applicable to MIM Software. Provide quality support for new product introductions and ongoing projects throughout the product development lifecycle. Provide Design Quality expertise in early to late-stage product development. The Design Control Specialist is responsible for adherence to the MIM software Quality Management System.

As a critical member of the NPI core team, you will ensure adherence to the MIM/GE HealthCare Quality Management System and regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. By employing strong critical thinking and influencing skills, you will work cross-functionally to ensure robust quality decisions. In this role, you will have a direct impact on ensuring patient safety, audit readiness, and the commercial delivery of MIM Software/ GE HealthCare systems.

**Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.**

Job Description

What You'll Do:

• Be a subject matter expert in Design Control regulations and applicable standards.

• Develop and manage design and development quality systems, and provide direction, support, and oversight of the program.

• Ensures building compliant new product development processes with adherence to FDA Design Control requirements and Risk Management ISO standards. 

• Perform a review of design projects and design control procedural deliverable requirements.

• Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed.

• Provide design control lifecycle, procedure, and policy training.

• Support product design related investigation of quality events such as nonconformities, CAPAs, customer complaints, etc.

• Serves as Quality lead on design change control submissions.

• Author and review Design Control documentation to support regulatory filings

• Determine compliance of processes and regulations. Supports efforts to ensure the organization operates within established policies/procedures and complies with all applicable governmental regulations, both domestic and foreign.

• Assist during audits in the room (supplier, critical supplier, notified body, or otherwise)

• Proficient knowledge of MIM’s product portfolios and Primary Products and classifications. 

• Stay current with the latest guidance documents, regulatory requirements, and industry best practices. 

• Assist in other areas of the QMS as directed by the manager.

What You'll Need:

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of relevant work experience).

• At least 5 years of relevant experience in Quality Assurance in a regulated industry, either Medical Devices or Pharmaceuticals, preferably with Software as a Medical Device (SaMD)  Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including but not limited to FDA CFR 21 820, ISO 13485, and MDSAP.

Desired Characteristics

• Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design Engineering in the Software as a Medical Device field (SaMD). 

• Demonstrated expertise in Medical Device Design Controls, Production and Process Controls, and Installation and Servicing.

• Strong influencing skills and ability to clearly communicate the requirements of Design Controls, Design Verification and Validation, Production and Process Controls, Corrective & Preventive Action (CAPA), and Risk Management across functions.

• Demonstrated ability to collaborate effectively and resolve conflicts.

• Capability to lead, develop, communicate, and implement compliance goals during crises.

• Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills.

• Proficiency in managing multiple priorities effectively.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.