Senior Manufacturing Engineer

Job Title

Job Overview:

Pay Range: $47.51hr - $52.51hr

Requirement/Must Have:

• Bachelor’s Degree in Engineering or Scientific field and 4+ years of industry or industry/education experience required.
• Master’s Degree or equivalent in Engineering or Scientific field and 3+ years of industry or industry/education experience required.
• Ph.D. or equivalent in Engineering or Scientific field with industry or industry/education experience required.
• Ability to manage multiple priorities and deliver results in a fast-paced manufacturing environment.
• Proven ability to work independently and exercise sound engineering judgment.
• Proficiency with Microsoft Office Suite, including Excel, PowerPoint, and Project.
• Knowledge of applicable FDA regulations and quality system requirements.

Responsibilities:

• Lead complex manufacturing improvement initiatives focused on yield stabilization, process capability improvement, capacity expansion, cost reduction, and operational risk mitigation.
• Identify, prioritize, and implement opportunities to optimize manufacturing processes using structured problem-solving methodologies, statistical analysis, Lean Manufacturing, and continuous improvement principles.
• Serve as a technical leader and subject matter expert for manufacturing processes, equipment, and associated technologies.
• Collaborate with Operations, Quality, Supply Chain, Maintenance, and other cross-functional teams to improve manufacturing performance and achieve business objectives.
• Lead investigations and resolution of complex manufacturing, quality, and compliance issues, including CAPAs, nonconformances, audit observations, process deviations, and customer-impacting events.
• Apply data-driven decision making and statistical techniques to evaluate process performance, identify root causes, and implement effective corrective and preventive actions.
• Support regulatory inspections, internal audits, and compliance initiatives as a technical expert within the manufacturing organization.
• Design and execute rigorous engineering studies, experiments, process validations, and equipment qualifications.
• Develop and execute protocols, analyze results, prepare technical reports, and recommend implementation strategies based on data and risk assessment.
• Support introduction and integration of new products, equipment, manufacturing technologies, and process improvements while ensuring compliance, manufacturability, and operational readiness.
• Ensure manufacturing equipment, tooling, fixtures, and processes meet safety, quality, performance, and regulatory requirements.
• Lead cross-functional projects from concept through implementation using project management tools, risk assessments, and structured execution plans.
• Influence engineers, technicians, operations personnel, and business partners to achieve project objectives without direct authority.
• Mentor engineers and technicians in engineering best practices, manufacturing process control, data analysis, and structured problem solving.
• Provide technical direction and training to technicians supporting manufacturing operations and engineering studies.
• Develop and maintain manufacturing documentation, work instructions, procedures, training materials, and engineering records to support operational excellence and knowledge transfer.
• Perform other incidental duties as assigned by Leadership.

Nice to Have:

• Experience in FDA-regulated manufacturing environments, preferably medical device manufacturing.
• Experience with CAPA systems, nonconformance investigations, audit support, change control, and risk management processes.
• Experience applying Design of Experiments (DOE), statistical process control (SPC), process capability analysis, and hypothesis testing.
• Experience supporting process validation and equipment qualification activities.
• Experience leading cross-functional manufacturing improvement projects with measurable business impact.
• Experience supporting new product transfers, equipment implementation, or manufacturing technology integration.
• Experience working with complex manufacturing equipment and automated production systems.

Skills:

• Technical Leadership.
• Manufacturing Expertise.
• Statistical Analysis.
• Lean Manufacturing.
• Continuous Improvement.
• CAPA.
• Process Validation.
• Equipment Qualification.
• Project Management.
• Microsoft Office Suite.
• FDA Regulations.

Qualification And Education:

• Bachelor’s Degree in Engineering or Scientific field.
• Advanced degree (Master’s or Ph.D.) in Engineering or Scientific field preferred.