Senior Manufacturing Engineer - Medical Devices

Kforce has a client that is seeking a Senior Manufacturing Engineer - Medical Device. We are working directly with the hiring manager on this search. The company offers a competitive compensation package including base salary, annual bonus, etc. This position is fully onsite in Carlsbad, CA.

Summary:The Senior Manufacturing Engineer will lead both new product introduction (NPI) and sustaining manufacturing activities for electro-mechanical based durable medical devices. This role is responsible for designing, developing, implementing, and controlling robust manufacturing processes that meet quality, regulatory, and business requirements. This position provides hands on technical leadership while influencing suppliers, internal stakeholders, and manufacturing teams.

Key Responsibilities:

• Lead the development, implementation, and optimization of manufacturing processes for both new and existing console medical devices
• Partner closely with global suppliers to define and evaluate manufacturing processes, equipment, tooling, and fixtures to ensure consistent product quality
• Plan and execute characterization studies, Design of Experiments (DoE), and process validations (IQ, OQ, PQ)
• Manufacturing Process Development & Realization for new console systems.
• Industrialization of design into manufacturing, meaning:
• Taking R&D design outputs
• Creating robust, scalable, compliant manufacturing processes
• Develop and release:
• Assembly drawings, Manufacturing procedures and work instructions, Forms, routers, and test methods
• Device Master Record (DMR) documentation, Manufacturing-focused risk management
• Support design transfer activities from R&D into production
• Heavy emphasis on documentation writing
• Design and introduce innovative processes, tooling, fixtures, and automation solutions* Bachelor's degree in Engineering (Mechanical, Electrical, or related discipline preferred)
• 6-8+ years of manufacturing or process engineering experience in a regulated environment; Specifically in medical device industry
• Hands-on experience supporting both New Product Introduction (NPI) and sustaining manufacturing for medical devices
• Experience with electronic and/or electromechanical medical devices or capital medical equipment
• Experience specifically with durable medical devices
• Strong background in DFM/DFA/DFMAT, Lean Manufacturing, DoE, process transfer, PFMEA, and structured problem-solving methodologies
• Familiarity and experience with all phases of Design Controls
• Strong experience and understanding of Risk Management processes.
• Solid understanding of medical device Quality Management Systems and FDA regulations
• Excellent written and verbal communication skills with strong organizational abilities
• Thrives in a fast paced, cross-functional environment
• Six Sigma certification preferred.
• Experience with tooling and fixture design
• Experience with CAD software; SolidWorks or equivalent preferred