Job Description
Engineering Manager
I’m currently partnered with a progressive medical device company based in Houston that is looking to bring on board a talented and driven Engineering Manager. This is a fantastic opportunity to join a company at the forefront of medical technology innovation, with a robust product pipeline and strong investment in R&D.
As Engineering Manager, you’ll play a key leadership role in guiding a multidisciplinary team of mechanical, electrical, and test engineers. With six direct reports, this position is ideal for someone who enjoys both strategic leadership and technical oversight, and who thrives in a hands-on, fast-paced development environment.
Key Responsibilities :
- Lead and manage a team of engineers working on the design, development, and validation of Class II and III medical devices.
- Provide technical direction and mentorship across mechanical, electrical, and test disciplines.
- Oversee engineering activities throughout the full product development lifecycle—from concept through to manufacturing support.
- Ensure adherence to all regulatory and quality requirements, including FDA, ISO 13485, and 21 CFR Part 820.
- Collaborate with cross-functional teams including R&D, Quality, Regulatory Affairs, and Operations to drive timely and compliant product delivery.
- Contribute to strategic decision-making regarding design controls, risk management, and continuous improvement initiatives.
- Participate in design reviews, verification / validation planning, and resolution of technical challenges in development and production.
Key Requirements :
Bachelor’s or Master’s degree in Engineering (Electrical, Mechanical, or related discipline).A minimum of 10 years of engineering experience, ideally within the medical deviceAt least 2 years of direct leadership or managerial experience, with a proven track record of building and developing high-performing teams.Working knowledge of regulatory standards including ISO 13485, 21 CFR Part 820, and IEC 60601.Excellent communication, project planning, and problem-solving skills.Ability to thrive in a collaborative, hands-on environment.This is a high-impact role offering the opportunity to lead engineering efforts on life-changing medical technologies, within a company that values innovation, technical excellence, and professional growth.
If you are interested in learning more, or know someone who might be a great fit, please reach out to me at o.archer@x4lifesciences.com .