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.