Senior Manufacturing Engineer

Smith & Nephew; Pittsburgh (Allegheny County); Hybrid; USD 70,000 - 110,000; Full time

Job summary

An innovative manufacturing engineering team seeks a Senior Manufacturing Engineer to drive new product development. This role involves collaborating with R&D and manufacturing teams to ensure high-quality deliverables while embracing the company's vision of 'Life Unlimited.' The successful candidate will lead efforts in process validation, design transfer, and automation, contributing to the future of medical technology. Join a forward-thinking company that values diversity, inclusion, and employee well-being, offering a hybrid work model and numerous benefits to support work-life balance.

Benefits

401k Matching Program

Tuition Reimbursement

Flexible Personal/Vacation Time Off

Medical, Dental, and Vision Insurance

Health Savings Account

Employee Assistance Program

Parental Leave

Fertility and Adoption Assistance

Discounts on Fitness Clubs

Discounted Stock Options

Qualifications

• 5+ years of experience in manufacturing engineering.
• Strong background in medical device industry and robotics.

Responsibilities

• Lead New Product Development projects and coordinate with R&D.
• Implement design transfer processes and validate manufacturing.

Skills

Engineering

Manufacturing Process Validation

Design for Manufacturability

Lean/Six Sigma

Problem Solving

Collaboration with R&D

Education

Bachelor's in Engineering

Master's in Engineering

Tools

Minitab

MS Project

Job description

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

We are a fast-paced, innovative manufacturing engineering team within Smith+Nephew Robotics working to launch new product development products to our partner manufacturing sites. We are seeking a Senior Manufacturing Engineer to help further our company’s vision – “Life Unlimited”. The successful candidate will be passionate about delivering high-quality work on schedule to meet our commitments to the business with the goal of furthering the future of medical technology. This position will be involved in a wide array of activities and projects and interact daily with our Quality, R&D, and Manufacturing teams located in Pittsburgh's growing Strip District.

**This position does not offer visa transfer or sponsorship now or in the future**

What you will be doing?

1. Act as the Manufacturing Engineering lead for New Product Development projects.
2. Coordinate activities between the NPD R&D team and the downstream manufacturing sites.
3. Build and revise work instructions, BOMs, and routers.
4. Design, develop, construct, and implement tools, fixtures, and gauges.
5. Implement design transfer process deliverables; collect the voice of the factory in design for manufacturability reviews and design transfer meetings.
6. Lead process validation efforts along with quality team support, including authoring and implementing protocols as required.
7. Implement automation as appropriate for site.
8. Lead efforts to submit Capital Expenditure requests for new equipment, tooling, and gauging.
9. Select and qualify equipment and build calibration/preventative maintenance specifications.
10. Lead production risk analysis via PFMEA; build process maps and control plans.
11. Analyze highly sophisticated technical manufacturing problems and provide innovative solutions.
12. Own and respond to CAPA investigations.
13. Support engineering and prototype builds, create schedules action items for release of new designs to production.
14. Support development and implementation of functional test solutions for manufacturing.

What you need to be successful?

1. BS (MS preferred) in Engineering or related field and 5+ relevant years of experience.
2. 3 years’ experience in the medical device industry or relevant related industry.
3. 3 years’ experience working in a manufacturing environment releasing and/or updating products.
4. Experience releasing new product development projects while meeting schedule commitments.
5. Experience in the medical device industry; experience with robotics and/or electromechanical products preferred.
6. Experience solving complex technical issues in manufacturing and driving resolution via collaboration with R&D.
7. Experience with qualification of plastic, metal, and electronic assembly processes.
8. In-depth understanding of process validation and the associated regulations (IQ/OQ/PQ).
9. Detailed understanding of Design for Manufacturability and a proven history of using DFM tools to drive design change.
10. Ability to lead and report on change in a structured way, including ability to build and share project plans using MS Project.
11. Ability to collect data and use Minitab (or similar) to calculate process capability and perform Design of Experiments, Measurement Systems Analysis, and other statistical studies.
12. Ability to craft and fabricate simple production fixtures and tools.
13. Understanding of Lean/Six Sigma methodologies and tools.
14. Proven knowledge and understanding of GD&T.
15. Travel Requirement – 10%.

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.

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