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
- Bachelor’s 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.