Job Summary: The Manufacturing Engineer will be responsible for supporting Selux’s consumables manufacturing program, with oversight and management of the automated manufacturing line for Selux AST Panels located at Selux’s contract manufacturer in the northern California area. This effort includes installation, commissioning, validation, maintenance and repair of the system, as well as testing, data collection and review, optimization of product inputs to the system to align with Selux product requirements and specifications and documenting best practices of operating the manufacturing line through WIs and SOPs. Candidates will report to the Manufacturing Engineering Manager and work within the Selux Operations team. Candidates will collaborate cross-functionally within the Selux organization with regards to product development and optimization, process validations, and NPI to manufacturing as new products are introduced. A successful candidate will be a self-starter that possesses a mix of technical and operational skills to effectively collaborate across functions and organizations.

Key Responsibilities:

• Collaborate directly with contract manufacturing partners as part of scale-up efforts on Selux’s AST Panel manufacturing program, including system support during validation, maintenance, and optimization activities.
• Ability to travel and visit Contract Manufacturing partners as necessary. Significant onsite support is anticipated during initial system installation and first year of operation runs.
• Collaborate cross-functionally within the Selux organization alongside Engineering, Chemistry, and Microbiology teams during product development, Quality for product and process documentation, V&V and Regulatory teams during product validation, and Operations for continued product support and improvement.
• Manage PM, repair, and inventory of spare parts for the panel manufacturing line.
• Work with Planning lead and Supply Chain Management to understand forecasts and develop production schedules with Contract Manufacturers.
• Provide support as necessary to develop and perform validation and verification for activities.
• Develop and report on KPIs of the panel manufacturing program.
• Remain current on cGMP and FDA guidelines as related to medical devices.
• Position allows for part-time work from home when scheduling permits.
• Other duties as assigned.

Preferred Qualifications:

• Bachelor’s degree in chemical engineering or other technical discipline, with 5+ years’ experience.
• Experience working with and managing contract manufacturing partners.
• Knowledge of Good Manufacturing Processes.
• Familiarity with the NPI process and design for manufacturing principles.
• Self-motivated, excellent oral and written communicator, goal oriented, and a team player.
• Ability to travel >50%

Target Salary Range: $96K-$125K