Process Engineer 3

Smith & Nephew; Columbia (MD); Hybrid; USD 97,000 - 145,000; Full time

Benefits offered by this job

Hybrid Work Model

Medical, Dental, Vision

401k Matching Program

Tuition Reimbursement

Paid Holidays

PTO and Vacation

Volunteer Time

Job summary

Smith+Nephew is seeking a Process Engineer 3 in Maryland to lead manufacturing process improvements and drive continuous improvement initiatives across production controls, equipment qualifications, and CAPA documentation.

You will support new product transfers from development to manufacturing, collaborate with cross-functional teams, and help ensure regulatory compliance while seeking cost-saving opportunities and manufacturing excellence.

Qualifications

• Bachelor's degree in Engineering or Life Sciences.
• 3+ years of manufacturing or process engineering experience in an FDA-regulated environment.
• Proficient in MS Office (Word, Excel, PowerPoint).
• Demonstrated ability to work in a professional, multi-disciplinary team as leader, facilitator, or participant.
• Effective verbal and written communication skills.
• Open, collaborative style; ability to work in team and autonomously with minimal supervision.

Responsibilities

• Lead the development and implementation of manufacturing process improvements, production controls, and efficiency initiatives.
• Drive risk assessments and gap analyses to strengthen current and future manufacturing processes.
• Oversee equipment and manufacturing process qualifications to support regulatory and operational requirements.
• Author, execute, and review change controls, validation protocols, CAPAs, and other quality system documentation.
• Support new product transfers from development into manufacturing and help ensure successful commercialization.
• Qualify new manufacturing equipment and support validation activities.
• Partner with cross-functional teams to identify and deliver cost-saving and business transformation opportunities.
• Develop user needs documentation and contribute to solution-driven manufacturing improvements.
• Conduct research and development activities to evaluate the feasibility of new ideas and technologies.
• Provide technical support and leadership across manufacturing operations as needed.

Skills

Verbal communication

Written communication

Cross-functional collaboration

Team leadership

Time management

Problem solving

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MS Office

Job description

Life. Unlimited.

At Smith+Naphew we design and manufacture technology that takes the limits off living.

Join a team where your engineering expertise will directly impact manufacturing excellence, product quality, and patient outcomes. As a Process Engineer 3, you will play a key role in driving continuous improvement initiatives, supporting new product introductions, and ensuring manufacturing processes and equipment meet the highest standards of compliance and performance.

What will you be doing?

• Lead the development and implementation of manufacturing process improvements, production controls, and efficiency initiatives

• Drive risk assessments and gap assessments to strengthen current and future manufacturing processes

• Oversee equipment and manufacturing process qualifications to support regulatory and operational requirements

• Author, execute, and review change controls, validation protocols, CAPAs, and other quality system documentation

• Support new product transfers from development into manufacturing and help ensure successful commercialization

• Qualify new manufacturing equipment and support validation activities

• Partner with cross functional teams to identify and deliver cost saving and business transformation opportunities

• Develop user needs documentation and contribute to solution driven manufacturing improvements

• Conduct research and development activities to evaluate the feasibility of new ideas and technologies

• Provide technical support and leadership across manufacturing operations as needed

What will you need to be successful?

• Bachelor's degree in Engineering or Life Sciences

• 3+ years of manufacturing or process engineering experience within an FDA regulated environment

• Proficient in MS Office software (Word, Excel, PowerPoint)

• Demonstrated ability to work in a professional, multi-disciplinary, multi-cultural team as a group leader, facilitator, or participant.

• Effective verbal and written communication skills.

• Open collaborative style; ability to work both in a team environment and autonomously with minimal supervision or direction

• Unfazed by ambiguity and comfortable in environments with shifting priorities

• Strong verbal and written communication skills, including solid interpersonal skills

• Proven time management and organizational skills

• Proven ability to build relationships across organizational departments and reporting structures.

Travel Requirements: 0-5%

You. Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more about Employee Inclusion Groups on our website.
Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, 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!

The anticipated base compensation range for this position is $96,750 - $145,000 USD anually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.

Smith+Naphew 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.