Manufacturing Engineer

Job Description

Manufacturing Engineer

Direct Hire

$90,000-$120,000 + Bonus & Profit Sharing

30%-40% Travel (This reduces to 20% after approx. 1.5 years)

(Onsite Dallas Facility – Bay Area Candidates would Relo. to Dallas after one year)

Company Overview:

The organization is a pioneering life sciences company based in Dallas, Texas, specializing in developing and commercializing innovative medical devices. With a commitment to improving patient care and outcomes, the company operates at the forefront of medical technology, integrating cutting-edge research and development with high-quality manufacturing processes. As an industry leader, the company fosters a culture of excellence, collaboration, and continuous improvement.

Position Summary:

Join a dynamic team in the life sciences sector as a Manufacturing Engineer. You'll report to the Director of R&D and play a crucial role in scaling up production and commercializing Class II medical devices. Your focus will be on developing and validating manufacturing processes, and closely collaborating with production, R&D, and RA/QA teams to advance product initiatives.

Key Responsibilities:

• Manage Contract Manufacturing Activities, addressing production, quality, and yield issues.
• Lead product development from clinical stages through to launch and commercialization.
• Oversee supply chain management and handle equipment maintenance and calibration.
• Implement strategies for cost reduction, reliability enhancement, and design for manufacturability (DFM) improvements.
• Conduct process improvements, validations, and ongoing test development.
• Maintain and improve technical documents, including BOMs, MPIs, and inspection procedures, through change order processes.
• Design tools to optimize manufacturing lines.
• Contribute to the R&D team in manufacturing strategy for future products.
• Assist Regulatory Affairs with documentation of manufacturing processes and materials.
• Develop FDA and ISO-compliant design history files, focusing on risk management.
• Uphold company standards for Good Manufacturing Practices.
• Support Quality Assurance in regulatory compliance tasks.

Required Qualifications:

• B.S. degree in Mechanical, Electrical, or Biomedical Engineering.
• At least 5 years of experience in life science manufacturing.
• Proficiency in injection molding and PCBA manufacturing.
• Strong technical troubleshooting and root cause analysis skills.
• Proven experience in supplier development and management.
• Familiarity with sterile disposable devices is an advantage.
• Knowledge of FDA QS regulations, ISO 13485, and Good Laboratory Practices.
• Self-motivated with excellent organizational and communication skills.
• Willingness to travel (15-20%, up to 40-60% if not located in California).

Required Technical Proficiencies:

• Proficiency in CAD (e.g., Solidworks).
• Skilled in MS Office, MS Project, and general business applications.
• Knowledge of statistical analysis systems (e.g., MATLAB, SAS) is preferred.

About the recruiter: My name is Kevin Walczak and I am a Talent Lead at CalTek Staffing, a boutique engineering search firm in San Diego, California. Interested candidates are encouraged to reach out to me via LinkedIn ( https://www.linkedin.com/in/nititalent/ ) and I'll be sure to respond within a few hours.