Sr. Manufacturing Engineer - Additive

Responsibilities

• Lead development and implementation of advanced metal additive manufacturing processes for orthopedic and medical device applications.
• Design, validate, and optimize production-ready AM workflows including build strategy, support design, post-processing, inspection, and quality controls.
• Develop Design for Additive Manufacturing (DFAM) strategies for complex implant geometries and lattice structures.
• Establish and improve additive manufacturing capabilities including equipment selection, lab setup, process validation, and manufacturing scale-up.
• Support material characterization activities including mechanical testing, microstructural analysis, chemistry analysis, and process capability studies.
• Drive continuous improvement initiatives focused on throughput, quality, scrap reduction, cycle time, and manufacturability.
• Lead cross-functional engineering projects from concept through commercialization.
• Develop and execute engineering studies, validation protocols, and testing plans in compliance with FDA, ISO 13485 and internal quality requirements.
• Translate R&D concepts into manufacturable and scalable production solutions.
• Participate in customer-facing technical discussions, DFM reviews, and project milestone meetings.
• Understand and comply with the Cretex professional competencies, company policies, and the employee manual.
• Collaborate with Quality Engineering to develop validated and capable manufacturing processes.
• Support root cause investigations, CAPA activities, and non-conformance resolution.
• Ensure appropriate documentation practices for protocols, work instructions, validation reports, and engineering records.
• Adhere to all safety policies; including wearing personal protective equipment when required.
• Support and comply with the company's QMS (Quality Management System), ISO 9001 and 13485 standards, GMP's (Good Manufacturing Practices), and GDP's (Good Documentation Practi

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Metallurgical Engineering, Manufacturing Engineering, or related field. Advanced degree preferred.
• 7+ years of engineering experience in additive manufacturing and medical device manufacturing environments.
• Strong, hands-on experience with metal additive manufacturing technologies including L-PBF and EB-PBF powder bed fusion systems.
• Experience developing manufacturing processes for orthopedic implants or regulated medical devices.
• Strong understanding of AM materials, microstructures, and production workflows.
• Experience with process validation, manufacturing scale-up, and production support.
• Knowledge of ASTM standards related to additive manufacturing and implant materials including ASTM F3001 preferred.
• Proficiency with CAD software such as SolidWorks, Creo, NX, or equivalent.
• Proficiency with Additive Manufacturing software such as 3DXpert or Materialise MAGICS.