Senior Process Engineer

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

The Senior Manufacturing Engineer plays a critical role in improving and developing manufacturing processes to produce high-quality medical devices efficiently. This role focuses on process optimization, waste reduction, and improving First Pass Yield (FPY) while minimizing scrap. The engineer will drive continuous improvement initiatives, support operations and shop floor teams, and implement cost-effective solutions to enhance production efficiency and quality.

What will you be doing?

Process Optimization & Scrap Reduction:

• Analyze and refine manufacturing processes to improve efficiency, reduce defects, and lower scrap rates.
• Implement Lean Manufacturing and Six Sigma methodologies to drive waste reduction and process control.
• Develop and execute strategies to enhance First Pass Yield (FPY) and ensure consistent product quality.
• Conduct root cause analysis on production issues and implement corrective and preventive actions (CAPA).

Production Support & Operational Efficiency:

• Provide daily technical support to shop floor teams to resolve manufacturing challenges.
• Work closely with Operations to optimize workflows, reduce downtime, and improve resource allocation.
• Develop, implement, and maintain manufacturing methods, operation sequences, and process documentation.
• Lead equipment installation and validation activities, including:
  • User Requirement Specifications (URS)
  • Factory Acceptance Testing (FAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation Report Approval (VRA)

Continuous Improvement & Cost Reduction:

• Drive continuous improvement projects to enhance production efficiency and reduce costs.
• Estimate manufacturing costs, establish time standards, and recommend tooling and process requirements.
• Develop and implement strategies to improve material utilization and reduce rework/scrap.
• Support the transfer of manufacturing processes and products between internal and external sites.

Layout Improvement & Space Planning:

• Evaluate and optimize facility layouts to improve material flow, equipment placement, and workspace efficiency.
• Create space for future growth, ensuring production scalability and technology integration.
• Collaborate with cross-functional teams to redesign workspaces and implement lean layouts.

Collaboration & Leadership:

• Work with Design Engineering to coordinate new product releases and ensure design for manufacturability (DFM).
• Lead cross-functional teams to support quality, production, and engineering initiatives.
• Mentor and guide junior engineers and manufacturing personnel to strengthen technical skills and process knowledge.

Compliance & Documentation:

• Ensure compliance with regulatory requirements and quality standards (ISO, FDA, etc.).
• Develop Process Maps, PFMEA, MSA, and other risk analysis tools.
• Participate in internal and external audits, providing documentation and process validation support.

What will you need to be successful?

• Bachelor's degree in Engineering (Mechanical, Manufacturing, Industrial, or related field).
• Experience: Minimum 5 years of experience in manufacturing engineering, process improvement, and scrap reduction.
• Proven track record of reducing scrap, improving FPY, and driving cost savings initiatives.
• Strong background in Lean Manufacturing, Six Sigma (Green/Black Belt preferred), and process validation.
• Experience with root cause analysis, CAPA, and statistical process control (SPC).
• Familiarity with Geometric Dimensioning and Tolerancing (GD&T) and process characterization.
• Proficiency in AutoCAD, SolidWorks, or similar CAD software for facility and process layout improvements.

Preferred Skills

• Experience in CNC machining, metal finishing, and passivation systems.
• Strong understanding of process control methodologies and continuous improvement strategies.
• Leadership in cross-functional teams and manufacturing projects.
• Medical device industry experience is a plus.

Work Environment & Physical Demands

• Works in a manufacturing setting, requiring occasional exposure to machinery, noise, and production areas.
• Requires standing, walking, and occasional lifting of up to 25 pounds.
• May require flexible work hours to support production schedules and urgent process issues.

You. Unlimited!

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.