Manufacturing Engineer IV
Location: Bethlehem, PA | Onsite
Salary: $105,000-$135,000 DOE
Travel: Minimal - approximately once per quarter or less
About the OpportunityOur client, a growing and highly regulated medical device manufacturer, is seeking an experienced Manufacturing Engineer IV to join their engineering team in Bethlehem, PA.
This senior-level position offers the opportunity to take ownership of manufacturing processes, engineering documentation, change controls, and continuous improvement initiatives while helping strengthen and advance engineering processes within a growing organization.
The ideal candidate will bring strong experience in FDA-regulated manufacturing, particularly within medical devices or other highly regulated manufacturing environments. This individual will work closely with Production, Quality, Engineering, and Product Development to improve manufacturing processes, resolve production challenges, and support new product initiatives.
Key Responsibilities- Lead manufacturing process improvements and continuous improvement initiatives
- Manage engineering change controls and related documentation
- Develop and maintain SOPs, work instructions, procedures, and other engineering documentation
- Support production with troubleshooting, root cause analysis, and process optimization
- Lead capital equipment and semi-automated manufacturing projects
- Partner with Product Development on new product introductions (NPI)
- Support quality, safety, cost reduction, and efficiency initiatives
- Drive Lean Manufacturing and continuous improvement projects
- Support CAPA activities and corrective/preventive actions
- Evaluate and improve manufacturing processes, equipment, tooling, and fixtures
- Collaborate cross-functionally with Engineering, Quality, Operations, and Product Development
- Provide project leadership and take ownership of engineering initiatives from concept through implementation
- Occasionally travel to machine builders and participate in Factory Acceptance Testing (FAT)
Required Qualifications- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Materials Engineering, or a related engineering discipline
- 5+ years of Manufacturing Engineering experience; 8+ years preferred
- Proven experience working in an FDA-regulated manufacturing environment
- Strong experience with engineering change control
- Experience writing and maintaining SOPs, procedures, work instructions, and technical documentation
- Demonstrated manufacturing process improvement experience
- Experience with root cause analysis and CAPA
- Lean Manufacturing experience
- Strong production support and troubleshooting experience
- Excellent communication, organizational, project management, and problem-solving skills
- Ability to work independently and manage multiple engineering projects
Preferred Qualifications- Medical device manufacturing experience
- Orthopedic device manufacturing experience
- ISO 13485 experience
- CNC machining knowledge, including milling and/or lathe operations
- Metal fabrication or metal products manufacturing experience
- Tooling and fixture design experience
- SolidWorks experience
- Semi-automated manufacturing systems experience
- Capital equipment project management experience
- Six Sigma certification
