Principal Manufacturing Engineer

Position Description

As a Principal Manufacturing Engineer, you will play a critical role in the design, validation, implementation, and continuous improvement of production processes for personalized aprevo devices. You will be responsible for owning manufacturing processes, leading process development projects, and driving cross-functional design collaboration. In addition to optimizing production processes, you will collaborate closely with Surgical, Quality, and Regulatory teams to ensure the highest level of quality and compliance in the development of personalized devices. To be successful in this role, you must be a team player, self-motivated, and committed to improving patient outcomes.

Responsibilities

• Lead and support manufacturing engineering activities to ensure efficient, high-quality production processes.

• Transfer new or improved processes from engineering to manufacturing to ensure seamless production scaling.

• Own gauge designs for both instrumentation and implants.

• Conduct DFM (Design for Manufacturability) analysis for NPI (New Product Introduction) and modifications to existing products.

• Own and drive pFMEA (Process Failure Mode and Effects Analysis) and associated validation strategies for NPI products.

• Draft, review, release, and execute process validation protocols (IQ/OQ/PQ) and test reports, collaborating with cross-functional teams and subcontractors.

• Support cleaning, packaging, and sterilization processes to ensure compliance with regulatory standards.

• Manage vendor relationships, including new vendor onboarding and sustaining support for equipment and processes.

• Conduct root-cause analysis and investigations for process failures, nonconformances, and identified quality issues.

• Create and maintain documentation relevant to design control, process validation, and regulatory requirements (ISO 13485, FDA).

• Ensure adherence to project timelines and compliance with FDA regulations, ISO standards, and internal quality systems.

Skills

• Expertise in interpreting engineering drawings, GD&T, and technical documentation.

• Proficiency in manufacturing process validations for machining, welding, heat treatment, etc.

• Familiarity with gauge design, fabrication, and maintenance.

• Strong problem-solving skills with the ability to work autonomously and in cross-functional teams.

• Ability to manage multiple projects in a fast-paced, regulated environment.

• Experience with CAD software (e.g., SolidWorks, Creo) and mechanical test methods.

• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) with strong report-writing skills.

• Willingness to take on multiple roles to support excellent patient outcomes.

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Mechatronic Engineering, Biomedical Engineering, or a related field required.

• 8+ years of experience in manufacturing engineering within a regulated environment (medical device, aerospace, or other highly regulated industry).

• Medical device industry experience (spine or orthopedics preferred).

• Strong understanding of ISO 13485, FDA 21 CFR Part 820, and other regulatory requirements for quality systems and medical devices.

• Experience in process validations (IQ/OQ/PQ), risk management, and regulatory compliance.

• Expertise in machining processes, GD&T (Geometric Dimensioning & Tolerancing), and design for manufacturing (DFM).

• Experience with novel process validation techniques (e.g., automation, additive manufacturing) is highly desired.

• Hands-on experience with cleaning, packaging, and sterilization for medical devices is a plus.

• Strong background in process development, root-cause analysis, and CAPA (Corrective and Preventive Actions).

Equal Opportunity Employer

Carlsmed is an equal-opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Carlsmed is committed to providing reasonable accommodation for candidates with disabilities in our recruitment process. If you need any assistance or accommodation due to a disability, please let us know.