Position: R&D Sustaining Engineer

Overview
The R&D Sustaining Engineer will lead projects and provide technical expertise to ensure the continued reliability, compliance, and cost-effectiveness of existing medical device products. This role plays a vital part in supporting products throughout their lifecycle by resolving manufacturing challenges, implementing design improvements, and driving continuous improvement initiatives. The engineer will work collaboratively with cross-functional teams—including Manufacturing, Quality, Supply Chain, and Regulatory Affairs—to maintain product quality and ensure compliance with all applicable standards.

Key Responsibilities

Project Leadership

• Lead small to mid-sized sustaining engineering projects focused on product and process improvements, cost reduction, and component obsolescence management.

• Develop and manage project plans, schedules, and deliverables to ensure timely and successful completion.

Manufacturing Support

• Serve as the primary R&D liaison for manufacturing and production support.

• Partner with Manufacturing Engineering to troubleshoot product and process issues, perform root cause analyses, and implement effective corrective and preventive actions (CAPAs).

Design & Process Changes

• Plan, coordinate, and execute sustaining engineering activities, including:

• Project scheduling and documentation updates

• Quality and regulatory documentation

• Labeling and Instructions for Use (IFU) updates

• Design requirements and specification trace matrices

• Real-time aging retention and testing

• Verification and Validation (V&V) testing, including protocol and report generation

• Returned product evaluations and competitive product benchmarking

• Change orders, technical reviews, and implementation support

Qualifications

Education

• Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering, or a related technical discipline.

Experience

• Minimum 4 years of experience in a regulated industry, with a focus on medical device product development or sustaining engineering.

• Experience with Class II or Class III medical devices preferred.

• Strong background in medical device component design, material processing, and manufacturing.

• Comprehensive understanding of ISO, GMP, and FDA regulations related to medical device design and development.

Skills & Competencies

• Strong analytical and problem-solving skills, with a solid understanding of design control processes, risk management, and process/design validation.

• Demonstrated project management expertise.

• Experience with lean manufacturing and continuous improvement methodologies.

• Excellent verbal, written, and presentation communication skills.

• Proficient in Microsoft Office and MS Project.

• Hands-on experience with SolidWorks.

• Working knowledge of medical device sterilization techniques and regulatory requirements.

• Ability to adapt and take on additional responsibilities to support evolving business objectives.