Manufacturing Engineer

• Provide Design for Manufacturability (DFM) & Design for Assembly (DFA) input to R+D teams during design reviews, and prototype iterations to optimize manufacturability, reliability, and cost.

• Participate in design risk management activities including dfMEA and pfMEA to identify and mitigate manufacturing-related risks.
• Evaluate design concepts for manufacturability, assembly feasibility, and cost-effectiveness.
• Support design transfer activities from R+D to manufacturing for new products.
• Develop and execute project plans for technology transfer, including timelines, equipment needs, and resource requirements.
• Create manufacturing workflow processes and detailed work instructions for new product.
• Develop and validate manufacturing processes (IQ/OQ/PQ) for new product lines.
• Design, build, and qualify custom equipment, fixtures, jigs, and manufacturing processes for prototype.
• Develop and validate custom equipment, fixtures, jigs, and manufacturing processes.
• Specify, document, procure, qualify, implement, and improve fixtures, hand tools, an equipment used in manufacturing.
• Design and build prototypes, fixtures, tools, and test systems that support product development and manufacturing.
• Determine, incorporate, and validate critical tests used in manufacturing to ensure product quality and performance.
• Develop test methods, simulation models, and reliability strategies to reduce design and manufacturing risk.
• Author and maintain design documentation for a regulatory controlled environment including process FMEAs, control plans, work instructions, and validation reports.
• Contribute to documentation for regulatory submissions (510(k), CE Mark Technical File) and maintain audit-ready records.
• Collaborate with R+D teams (mechanical, electrical, systems) to characterize new hardware designs and emerging technologies.
• Work with Quality, Regulatory, Supply Chain, and Operations teams to ensure compliance with medical device standards (ISO 13485, ISO 14971, FDA 21 CFR 820).
• Define equipment specifications, lead procurement, installation, and commissioning of manufacturing equipment.
• Ensure all manufacturing process development activities comply with FDA 21CFR 820, ISO 13485 design controls and production controls, and global regulatory standards.
• Perform all work in compliance with the company Quality Management System (QMS), including creation, review, and maintenance of required documentation.
• Provide technical guidance and training to operators and technicians on manufacturing processes and best practices.
• Follow Design Control for medical devices to ensure compliance to company's Quality Management System and ISO 13485.
• Perform other ad-hoc duties as assigned by immediate supervisor.

Education

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Mechatronics, or related field.

Experience

• 3-5 years of experience as a manufacturing engineer, process engineer, or advanced manufacturing engineer supporting product development with significant mechanical/electromechanical content.
• Direct experience with surgical, endoscopic, urological, or minimally invasive devices is highly desirable.

Skills

• Understanding of FDA 21 CFR 820, ISO 13485 design controls and production controls, and risk management (ISO 14971).
• Hands-on experience with manufacturing process development, test fixture design, CAD tools (e.g., SolidWorks), and electro-mechanical assembly processes.
• Proficiency in statistical analysis tools (e.g., Minitab, JMP) for process capability analysis, DOE, and validation data interpretation.
• Experience with Lean, Six Sigma, and continuous improvement methodologies.
• Hands-on experience with FDA 510(k), EU MDR, and global regulatory pathways for Class II/III devices.
• Understanding of design transfer, process validation, and manufacturing expectations in regulatory filings.
• Excellent written and verbal communication for protocol authoring, report writing, and cross-functional collaboration.
• Problem-solving mindset with ability to drive root-cause investigations and process improvements.