Manufacturing/Process Development Engineer

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.