Suru
Manufacturing Engineer
Job Description We are seeking a Manufacturing Engineer to support the industrialization, optimization, and continuous improvement of products and processes in a regulated manufacturing environment. This person will work cross-functionally with Operations, Quality, and Customer Service to drive new product introduction (NPI), process optimization, and cost reduction initiatives. The ideal candidate will bring strong technical problem-solving skills, hands-on manufacturing experience, and the ability to manage multiple projects with minimal supervision.
Day-to-Day Partner with Operations, Quality, and Design Engineering to support commercialization, process improvements, and cost reduction initiatives. Lead root cause investigations, corrective/preventative actions, and process optimization efforts for internal and external product or process issues. Specify, source, and qualify capital equipment to support manufacturing needs. Author and maintain technical and process documentation, including IQ/OQ/PQ, control plans, process flows, and PFMEAs. Analyze mechanical designs, drawings, and measurement systems to ensure manufacturability and alignment with design intent. Integrate DFM/DFA and Design-to-Cost principles during verification and validation activities. Conduct labor and process studies, analyze data against standards, and drive yield improvements and cost reductions. Collaborate with internal teams and external partners to implement and sustain product and process enhancements.
Requirements / Qualifications Bachelors degree in Engineering. 5+ years of manufacturing engineering experience. Proficiency with 2D/3D drawings, Bill of Materials, process flow diagrams, control plans, PFMEAs, and process documentation. Strong project management, organizational, and time management skills. Hands-on experience with root cause analysis, process optimization, and equipment qualification. Excellent communication and interpersonal skills with the ability to collaborate across functions. Preferred: Single-use consumable or biotech device development experience. Process characterization using DOE. Statistical Process Control (SPC) experience.
Job Description We are seeking a Manufacturing Engineer to support the industrialization, optimization, and continuous improvement of products and processes in a regulated manufacturing environment. This person will work cross-functionally with Operations, Quality, and Customer Service to drive new product introduction (NPI), process optimization, and cost reduction initiatives. The ideal candidate will bring strong technical problem-solving skills, hands-on manufacturing experience, and the ability to manage multiple projects with minimal supervision.
Day-to-Day Partner with Operations, Quality, and Design Engineering to support commercialization, process improvements, and cost reduction initiatives. Lead root cause investigations, corrective/preventative actions, and process optimization efforts for internal and external product or process issues. Specify, source, and qualify capital equipment to support manufacturing needs. Author and maintain technical and process documentation, including IQ/OQ/PQ, control plans, process flows, and PFMEAs. Analyze mechanical designs, drawings, and measurement systems to ensure manufacturability and alignment with design intent. Integrate DFM/DFA and Design-to-Cost principles during verification and validation activities. Conduct labor and process studies, analyze data against standards, and drive yield improvements and cost reductions. Collaborate with internal teams and external partners to implement and sustain product and process enhancements.
Requirements / Qualifications Bachelors degree in Engineering. 5+ years of manufacturing engineering experience. Proficiency with 2D/3D drawings, Bill of Materials, process flow diagrams, control plans, PFMEAs, and process documentation. Strong project management, organizational, and time management skills. Hands-on experience with root cause analysis, process optimization, and equipment qualification. Excellent communication and interpersonal skills with the ability to collaborate across functions. Preferred: Single-use consumable or biotech device development experience. Process characterization using DOE. Statistical Process Control (SPC) experience.