Process Engineer

Smith & Nephew - Columbia, MD

Full-time - Mid Level

Columbia, MD

Merchant Wholesalers, Durable Goods

About the position

At Smith+Nephew, we design and manufacture technology that takes the limits off living. The Process Engineer will lead oversight on manufacturing processes including implementation of continuous improvements to optimize current manufacturing processes and providing support during new product development. This role will also provide qualification and validation support for manufacturing equipment. The Process Engineer will be responsible for leading the development of process improvements, methods, and production controls. This includes conducting risk assessments and addressing gap assessments in manufacturing, both for current and future processes. The engineer will coordinate manufacturing process and equipment qualifications, authoring, executing, and reviewing Manufacturing Change Controls, Validation protocols, and CAPAs. Additionally, the role involves qualifying new equipment for manufacturing processes and identifying areas for improvement in manufacturing efficiencies and compliance. The Process Engineer will compile user needs documents to drive a solution-based approach to manufacturing and business transformation, and lead multi-functional teams to find opportunities for Cost Saving Initiatives. Research and development activities will also be undertaken to confirm the feasibility of ideas ahead of case generation.

Responsibilities

• Lead the development of process improvements, methods, and production controls.
• Conduct risk assessments and address gap assessments in manufacturing processes.
• Coordinate manufacturing process and equipment qualifications.
• Author, execute, and review Manufacturing Change Controls, Validation protocols, and CAPAs.
• Qualify new equipment for manufacturing processes.
• Identify areas for improvement in manufacturing efficiencies and compliance.
• Compile user needs documents to drive a solution-based approach to manufacturing and business transformation.
• Lead multi-functional teams to find opportunities for Cost Saving Initiatives.
• Undertake research and development activities to confirm feasibility of ideas ahead of case generation.

Requirements

• Bachelor's degree in Engineering or Life Sciences required.
• 2+ years of relevant manufacturing process engineering experience in an FDA controlled environment.
• Proficient in MS Office software.
• Ability to work in a professional, multi-disciplinary, multi-cultural team as a group leader, facilitator, or participant.
• Open collaborative style with the ability to engage others and work autonomously with minimal supervision or direction.
• Comfortable in environments with shifting priorities and unfazed by ambiguity.
• Strong verbal and written communication skills, including interpersonal skills.
• Proven time management and organizational skills.
• Ability to establish relationships across organizational departments and reporting structures.

Benefits

• 401k Matching Program
• 401k Plus Program
• Discounted Stock Options
• Tuition Reimbursement
• Flexible Personal/Vacation Time Off
• Paid Holidays
• Flex Holidays
• Paid Community Service Day
• Medical, Dental, Vision Insurance
• Health Savings Account (Employer Contribution of $500+ annually)
• Employee Assistance Program
• Parental Leave
• Fertility and Adoption Assistance Program
• Hybrid Work Model
• Discounts on fitness clubs, travel and more!