We are seeking a Manufacturing Process Engineer to lead and support new product development and ongoing enhancements for our console medical devices. This role involves designing, developing, implementing, and refining manufacturing processes to ensure high-quality production. You will collaborate with cross-functional teams in a fast-paced environment, providing essential support for products, processes, materials, and equipment.

Responsibilities

• Design and implement innovative manufacturing processes for both new and existing console medical devices.
• Collaborate with global suppliers to assess and optimize their manufacturing processes, equipment, and tools to ensure product quality.
• Conduct characterization studies, Design of Experiments (DoE), and validation/verification of manufacturing processes and inspection methods (IQ, OQ, PQ).
• Develop comprehensive manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
• Lead and mentor a team of engineers and technicians on manufacturing-related activities.
• Drive innovation in processes, procedures, tooling, and automation.
• Train manufacturing personnel and provide ongoing guidance.
• Implement functional excellence initiatives for product/process improvement and technical development.
• Monitor progress against KPIs/metrics and initiate improvement projects as needed.
• Assist in the development of departmental budgets, schedules, and resource planning.
• Other duties as assigned.

Qualifications

• Bachelor's Degree in Engineering (Mechanical, Electrical, or related field preferred).
• Minimum of 4 years of experience as a process/manufacturing engineer in a regulated environment, ideally within the medical device industry.
• Strong background in Design for Manufacturing, Assembly, and Test (DFMAT), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer, and FMEA.
• Familiarity with medical device Quality Management Systems, design controls, and product development processes.
• In-depth understanding of FDA regulations, guidelines, and policies relevant to medical devices.
• Excellent verbal and written communication skills, along with strong organizational abilities.
• Six Sigma Certification preferred.
• Proficient in CAD software, preferably SolidWorks.

Work Environment and Physical Requirements

This role is primarily office-based within a manufacturing environment, with no adverse conditions expected. Physical activities may include:

• Prolonged periods of standing or sitting.
• Repetitive motions, such as keyboarding, which may involve the wrists, hands, and fingers.
• Effective communication with team members.
• Lifting, moving, or adjusting objects weighing up to 50 pounds.