Manufacturing Engineer

Manufacturing Engineer at Orion Placement Manufacturing Engineer at Orion Placement in Addison, Texas Posted in 1 day ago.

Type:

full-time

Job Description:

Pay:

$75,000.00 - $100,000.00 per year Why This Is a Great Opportunity Join a mission-driven medical device company helping bring life-saving ventilator technology to market. Play a key role in full-scale production of an FDA-cleared medical device. Work hands-on across manufacturing, engineering, quality, suppliers, and contract manufacturing. Be part of a highly experienced leadership team with a strong track record in medical device innovation. Make a direct impact on product quality, manufacturability, production capacity, and patient care. Location This is an on-site role based in Carrollton, TX. Candidates should be local to the Carrollton area and comfortable working on-site the majority of the time. Note Candidates must have experience in an FDA-regulated environment, an engineering background, and hands-on production or manufacturing experience. Medical device manufacturing experience is strongly preferred. About Us We are a growing medical device company focused on developing practical, life-saving technology that improves access to critical respiratory care. Our team is led by experienced medical device entrepreneurs, engineers, and clinical specialists with a long history of bringing innovative healthcare products to market. Confidential Employer. Job Description Oversee manufacturing of an FDA-regulated medical device in partnership with our contract manufacturer. Serve as a technical bridge between electrical, mechanical, software, manufacturing, quality, and supplier teams. Support production, process improvement, quality, manufacturability, and capacity initiatives. Contribute to component design, design improvements, and production-ready engineering solutions. Create and maintain structured BOMs, work instructions, manufacturing specifications, and technical documentation. Generate and support ECRs and ECOs, including rationale, verification, validation, and documentation. Work with injection molders, machining vendors, PCB fabricators, EMS partners, and other suppliers. Translate engineering drawings, GD&T, cosmetic standards, and regulatory requirements into clear supplier expectations. Identify manufacturing issues related to design, process, or components and drive resolution with cross-functional teams. Support verification and validation activities to confirm design specifications and evaluate potential failure modes. Maintain documentation in accordance with FDA regulations, ISO standards, and internal design control processes. Coordinate project schedules with suppliers, internal teams, customers, and leadership. Qualifications 2+ years of directly relevant medical device manufacturing experience. Bachelor's degree or higher in Mechanical Engineering, Industrial Engineering, or a related engineering discipline. Experience working in an FDA-regulated environment. Experience with production, manufacturing processes, quality systems, and regulated documentation. Familiarity with FDA, ISO, GMP, and medical device manufacturing requirements. Experience with BOMs, ECOs, ECRs, work instructions, manufacturing specifications, and design controls. Strong communication skills with the ability to work across engineering, manufacturing, quality, and supplier teams. Ability to work independently, manage multiple projects, and drive issues to resolution. Willingness to travel up to 10%. Must be authorized to work in the United States without visa sponsorship. Why You Will Love Working Here You will help build technology that can make critical care more accessible and easier to deliver. You will have real ownership in a role that touches design, manufacturing, quality, suppliers, and production. You will work with a small, experienced team where your contributions will be visible and meaningful. You will be part of a company with strong medical device leadership and a product already cleared for production. You will have the opportunity to improve processes, solve technical problems, and help scale a life-saving product.

JPC-1089

Benefits:

Dental insurance Paid time off Retirement plan Vision insurance