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Key Responsibilities:

• Design and develop equipment, processes, and control systems for production and assembly.
• Manage evaluation and selection of new equipment/technologies.
• Support ongoing optimization and improvement in equipment/systems/processes.
• Establish operating specifications, define process windows, and improve manufacturing techniques/processes.
• Provide support to non-engineering Staff for successful technology transfer.
• Write and report Protocols, Reports, SOP's, and Work Instructions.
• Statistically characterize processes and implement controls for consistency.
• Design 3D CAD models, create drawings, and collaborate with vendors.
• Provide troubleshooting, process, and manufacturing assistance.
• Comply with regulatory, corporate, and Quality System policies.
• Support Deviation Management, CAPA, and Change Control activities.
• Perform other duties as assigned.

Qualifications:

• BS or MS in engineering or relevant discipline.
• 5+ years of experience (3+ with Masters) in process development within medical device or GMP regulated industry.
• Experience leading and managing new process development initiatives.
• Understanding of cGxP principles and practices, ISO standards, and 21CFR820.
• Proficiency with 3D CAD software, preferably Solidworks.
• Strong statistical knowledge, technical writing, and presentation skills.
• Hands-on problem-solving approach, Six-sigma Green Belt/DMAIC experience preferred.
• Ability to work independently, multitask, and support multiple projects.
• Strong interpersonal, presentation, and teamwork skills.

Desired Skills:

• Familiarity with ISO 13485, ISO 14971.
• Knowledge of global cGMP requirements.
• Six-sigma Green Belt or DMAIC problem-solving experience.
• Proficiency in Solidworks or similar 3D CAD software.