Manufacturing Engineer

Job Description

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