Manufacturing Manager

Come join a growing Medical Device Company in your area!This Jobot Job is hosted by: Chris GormanAre you a fit? Easy Apply now by clicking the "Apply" buttonand sending us your resume.Salary: $175,000 - $185,000 per yearA bit about us:We are a Medical Device Manufacturing company that was founded with patient comfort in mind. Over 500 Million men worldwide suffer from enlarged prostate issues leading to urinary obstruction and many of them do not see effective relief from drugs, yet decline to undergo an invasive surgical procedure. Working in collaboration with the best urologists in the world, we made it our mission to come up with a new approach that is safer and more effective than any other option available. Our device is designed for a simple, atraumatic procedure in the urologist's office and ongoing clinical trials have shown positive results up to four years after treatment.Why join us?What We Offer: Competitive base salary plus equity Full benefits: Medical, Dental, Vision Generous PTO, vacation, sick, and holidays Life Insurance coverageJob DetailsJob Details: We are currently seeking a dynamic and innovative Manufacturing Manager to join our team. The ideal candidate will have a strong medical equipment background and a deep understanding of 13485, FDA, QSR, CAD, and Solidworks. You will scale up development/clinical-stage disposable medical devices with a primary focus on design for manufacturability, cost, yield improvement, and reducing assembly time/labor content. This permanent role offers the opportunity to work with a team of dedicated professionals in a fast-paced, high-tech environment.Responsibilities:1. Design and improve implant delivery and CMOS-based imaging systems for manufacturability by reducing parts and improving assembly techniques to increase yields and reduce labor content.2. Collaborate with R&D engineers and vendors to implement product changes that streamline manufacturing and assembly processes.3. Ensure compliance with QSR systems, including quality assurance, pre-clinical testing, and post-production procedures, while coordinating with the Document Control, Clinical, and Quality Assurance teams.4. Maintain detailed documentation of designs, materials, processes, and results, including lab notebooks and technical drawings using Solidworks.5. Develop and conduct testing protocols, complete experiments, and generate written reports, while providing feedback on product revisions or new designs.6. Manage vendors to secure parts and assemblies efficiently and cost-effectively, ensuring timely completion of projects aligned with corporate goals.7. Train production assemblers on new processes, support product safety and complaint resolution, and maintain a clean, organized, and safe work environment.Qualifications:1. Bachelor’s degree in Mechanical Engineering or a related field.2. Minimum of 10 years of experience in an engineering role, with a focus on medical equipment.3. Proven experience in managing manufacturing processes in compliance with FDA, QSR, and ISO 13485 regulations.4. Proficiency in CAD and Solidworks is essential.5. Extensive experience with injection molding, including tool design, material selection, and process optimization is a plus.6. Demonstrated experience in catheter assembly and production is a plus.7. Excellent leadership and team management skills.Interested in hearing more? Easy Apply now by clicking the "Apply" button.