<p>RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients - faster, safer, better.</p> <p>We don't make MedTech. We make MedTech happen.</p> <p>Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.</p> <p>Position Summary</p> <p>The R&D Engineer will support the design, maintenance, and continuous improvement of Intravascular Lithotripsy (IVL) and related accessories, with a primary focus on sustaining engineering activities for the manufacturing line. This role requires a senior-level engineer who can work independently, collaborate cross-functionally, and effectively support manufacturing, quality, and design stakeholders along with a 2nd resource a little more Jr. that can work in support of related tasks.</p> <p>Key Responsibilities</p> <ul> <li>Provide engineering support to the manufacturing line for the Intravascular Lithotripsy (IVL) and associated accessories. </li><li>Update and maintain engineering drawings and prints to support manufacturing, quality improvements, and design changes. </li><li>Serve as an engineering liaison with contract manufacturers and internal operations and design teams. </li><li>Support CAPAs, nonconformance investigations, and root cause analyses as needed. </li><li>Contribute to manufacturing issue resolution, process improvements, and product sustainment activities. </li><li>Ensure engineering documentation complies with applicable quality system and regulatory requirements. </li></ul> <p>Required Qualifications</p> <ul> <li>Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a related discipline. </li><li>3-5 years of experience in the medical device industry. </li><li>Senior-level engineer with the ability to take direction while also working independently and proactively. </li><li>Demonstrated experience creating, updating, and interpreting engineering drawings/prints (required). </li><li>Experience supporting manufacturing operations and working with contract manufacturers. </li><li>Strong communication skills and ability to collaborate effectively across engineering, quality, and operations teams. </li><li>Experience supporting Class II or Class III medical devices. </li><li>Familiarity with CAPA processes, investigations, and quality systems in a regulated environment. </li><li>Hands-on experience in sustaining engineering or manufacturing support roles. </li></ul> <p>Work Environment/Physical Demands: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.</p> <p>Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!</p> <p>We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.</p> <p>Job Opportunity Verification</p> <p>At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:</p> <p>All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers</p> <p>Every candidate going through the interview process will participate in a voice and/or video interview.</p> <p>Exercise caution with unsolicited job offers or requests for sensitive information.</p>