Sr. Manufacturing Engineer

Job Responsibilities:

• Maintain mfg. floor equipment – evaluate processes & equipment to identify areas of improvement
• Partner with Mfg. team to resolve issues/concerns, etc.
• Ensure strong adherence to process efficiency, product quality, safety compliance, & cGMPs – create & implement processes/SOPs, etc.
• Manage mfg. engineering projects and ensure timelines are met – planning, executing, troubleshooting, etc.
• Mentor junior employees – foster a team oriented & collaborative environment
• Identify opportunities for efficiency & cost reduction
• Support NPD/NPI initiatives and provide guidance on DFMA
• Support production schedules & product delivery timelines
• Prepare KPIs reports for leadership
• Support & troubleshoot complex product performance issues
• Review engineering changes to meet spec requirements
• Promote Lean Mfg. initiatives & continuous improvement
• Delegate tasks as needed
• Ensure quality standards – ISO 13485
• Ensure compliance with industry regulations
• Partner cross-functionally to support organizational goals
• Maintain a safe & compliant work environment
• Other duties as needed

Job Requirements:

• Bachelor's degree in Mechanical, Mfg., Industrial Engineering, or similar
• 7+ years of relevant manufacturing engineering experience – lean mfg. environment experience required
• 3+ years of project management experience
• Hands-on experience with floor mfg. equipment (CNC, Mills, Automation, Robotics, 3D, etc.)
• Experience with Solidworks, MiniTab/JMP, etc.
• Strong knowledge of Lean Manufacturing, cGMP, & Med Device regulations - Familiarity with ISO 13485
• Strong project management skills
• Experience creating and implementing SOPs preferred
• Strong written & verbal communication skills