Manufacturing Engineer

Pay: $75000.00 - $100000.00 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.
• Bachelors 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

Requirements: Must-haves: 2 yrs medical manufacturing exp. Exp working in an FDA-regulated environment. Exp in production or manufacturing engineering.

• Nice to haves:

• Additional context: Relocation- yesno. Packages - yesno

• Salary Bands:

  • 3 to 4 years directly relevant experience: $75k to $80k

  • 5 to 7 years directly relevant experience: $80k to $90k

  • 8 years directly relevant experience with strong medical device manufacturing experience: $90k to $100k

Submission Email: Glenn - ;

Quick Recruiter Reference

Medical device company in Carrollton TX hiring an on-site Manufacturing Engineer to support production of an FDA-cleared portable ventilator. Must have FDA-regulated environment experience engineering background and production/manufacturing experience. Ideal candidate has 3 years in medical device manufacturing with BOM ECO/ECR supplier documentation and quality/process improvement experience.

Recruiters Submission: To submit cancel - Manufacturing Engineer - Ventis Medical - JPC 1089 - Source

**New Job Order Alert**

• Client job title: Manufacturing Engineer

• Location: Carrollton TX

• On-site hybrid remote: On-site

• Experience: 2

• Good fit job titles/keywords for candidates: Manufacturing Engineer Medical Device Manufacturing Engineer Production Engineer Process Engineer Quality Manufacturing Engineer NPI Engineer Supplier Quality Engineer Mechanical Engineer Industrial Engineer FDA ISO 13485 GMP BOM ECO ECR design controls contract manufacturer.

• # of hires needed: 1

• Open or not to recruiters on TE: NO

• Job posting strategy (bottom of package details): idk role dallas medical manufacturing engineer. 2 yrs