8 jobs found in Detroit, MI

JOB SUMMARY Lead contract manufacturing projects from concept through production, ensuring robust process design, manufacturability, and ongoing improvement. Support production teams, drive continuous improvement, maintain compliant documentation, and collaborate directly with customers and cross-functional teams. Ensure all processes and specifications meet QMS, FDA 21 CFR Part 820, and ISO 13485 requirements. PRINCIPLE RESPONSIBILITIES AND RESULTS Contract Design & Development Lead design and development for OEM/contract manufacturing projects. Manage prototypes, first articles, design risk mitigation, and product testing. Apply DFM principles and create/maintain design documentation (DHF, DMR, V&V, FMEAs). Verify design outputs vs. inputs and support quality planning. Lead project timelines, milestones, and cross-functional meetings. Contract Manufacturing Lead (OEM projects) Evaluate new or revised product designs for manufacturability and...

JOB SUMMARY Drive continuous improvement efforts to increase efficiency and lower potential for scrap. Ensure manufacturing processes are accurate and appropriate for converting engineering design specifications to a product that achieves customer requirements; coordinate cross functionally as appropriate. Support personnel on any production related issues such as processing problems or document non-conformances. Develop, document and utilize proven manufacturing processes; conduct and document process capabilities as appropriate. Support and or engage in direct communication with customers to understand product to improve design for manufacturability and align process capability. Control product and process specifications to comply with quality management system ("QMS"), FDA 21 CFR Part 820, and ISO 13485 requirements. PRINCIPLE RESPONSIBILITIES AND RESULTS Continuous Improvement Use LEAN Manufacturing principles and other methods to identify and implement cost savings...

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day. We all have the power to help, heal and change lives - beginning with our own. That's the power of the Cleveland Clinic Health System team, and The Power of Every One. Job Title Facilities Engineer II Location Cleveland Facility Cleveland Clinic Main Campus Department Engineering-Operations Job Code T98302 Shift Days Schedule 8:00am-5:00am Job Summary Job Details Join Cleveland Clinic's Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world-class, and caregivers are family. Cleveland Clinic is recognized as one of the top hospitals in the country. You will work alongside passionate and dedicated caregivers, receive endless support and appreciation, and build a...

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. JOB SUMMARY The Manufacturing Mechanical Engineer II is responsible for developing, implementing, and continuously improving manufacturing processes for mechanical and electromechanical products, with a focus on quality, efficiency, cost, and repeatability. This role applies mechanical engineering expertise and DFO principles to develop tooling, fixtures, equipment, automation, documentation, and process controls that support sustainable low-cost production. The Manufacturing Engineer works closely with Engineering, Quality, Operations, Supply Chain, and suppliers to support new product introduction, resolve manufacturing issues, and implement process improvement and new equipment. ESSENTIAL DUTIES AND RESPONSIBILITIES Lead continuous improvement and cost-reduction initiatives using structured problem-solving, documentation...

Position Summary The Process Engineer will continuously improve the safety, quality, and efficiency of the plant's manufacturing processes in order to meet or exceed customer expectations. Responsible for leadership and to ensure priorities and performance are aligned with the company's strategic direction. A technical and hands-on position requiring work in individual and team settings, contributing to all aspects of corporate efficiency and continuity. Project management, needs analysis, design review, testing, implementation, validation, and ongoing support of systems solutions. Primary Responsibilities / Essential Function Safety Ensure that new and existing manufacturing equipment modifications are designed to minimize safety hazards. Ensure that all manufacturing equipment is operated in the safest possible manner. Ensure that manufacturing and converting processes incorporate safe work practice and limit the risk of ergonomic injury. Quality Design new...

Job Description Position Summary The Sustaining Engineer is responsible for leading cross-functional projects and engineering initiatives that support the continued manufacture, regulatory compliance, and supply of commercialized medical devices. This role serves as a key liaison between Engineering, Quality, Regulatory Affairs, Supply Chain, Manufacturing, and external suppliers to evaluate, implement, and document product, component, material, and packaging changes. The Sustaining Engineer drives timely resolution of technical and supply-related challenges affecting on-market products by developing risk-based solutions, coordinating design and validation activities, and executing change management processes. This position plays a critical role in ensuring continuity of supply, product quality, and compliance with applicable regulatory requirements. Essential Duties and Responsibilities: Sustaining Engineering & Product Lifecycle Management Lead...

Job Summary: The Utilities Engineer plays a critical role in maintaining the reliability and efficiency of our utility systems that support pharmaceutical manufacturing. This includes managing and ensuring the smooth operation of systems such as HVAC, compressed air, chilled water, steam, purified water, electrical, and waste systems. The position is essential for minimizing downtime, meeting regulatory requirements, and maintaining a safe and compliant environment for production. Duties/Responsibilities: Oversee and maintain the operation of all utility systems including HVAC, water systems (pure water, potable water), steam generation, compressed air, and electrical systems in a cGMP environment. Perform preventive maintenance, calibration, and troubleshooting of utilities equipment to ensure operational reliability and compliance with cGMP and safety standards. Collaborate with cross-functional teams (e.g., Production, Quality, Engineering) to ensure utility systems...

Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins. Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen - you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases. What sets Forge apart is our culture of H.O.P.E. We are hardworking , showing up each day with determination and grit. We are open ,...