Senior Manufacturing Engineer - Medical Devices

Senior Manufacturing Engineer – Medical Device (Carlsbad, CA – fully onsite)

The Senior Manufacturing Engineer will lead new product introduction (NPI) and sustaining manufacturing activities for electro‑mechanical durable medical devices. The role involves designing, developing, implementing, and controlling robust manufacturing processes that meet quality, regulatory, and business requirements while providing hands‑on technical leadership across suppliers, internal stakeholders, and manufacturing teams.

• Lead the development, implementation, and optimization of manufacturing processes for 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 and realization for new console systems.
• Industrialization of design into manufacturing, including:
• Taking R&D design outputs.
• Creating robust, scalable, compliant manufacturing processes.
• Develop and release assembly drawings, manufacturing procedures, work instructions, forms, routers, and test methods.
• Develop Device Master Record (DMR) documentation and 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 the medical device industry.
• Hands‑on experience supporting both 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;
  Solid Works or equivalent preferred.

We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off; hourly employees are not eligible for paid time off unless required by law.

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.