Senior Manufacturing Engineer

Pay Range: $52.77hr - $57.77hr

Job Overview:

Applies advanced engineering knowledge, technical leadership, and manufacturing expertise to improve and sustain manufacturing processes within a highly regulated medical device environment. This role serves as a technical leader supporting critical implantable component manufacturing operations and is responsible for driving yield improvement, capacity expansion, process robustness, and compliance excellence through structured problem-solving, statistical analysis, and cross-functional collaboration. The Senior Manufacturing Engineer will lead complex manufacturing initiatives, provide technical direction to engineers and technicians, and support both existing commercial product lines as well as integration of next-generation products, equipment, and manufacturing technologies. Success in this role requires demonstrated experience delivering measurable manufacturing improvements, resolving complex technical challenges, and influencing change without direct authority. This position supports second-shift manufacturing operations and requires a high degree of independence, technical ownership, and decision-making capability in an environment with limited on-shift engineering support.

Key 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.
• Collaborable 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.

Education and Experience:

• 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.

Additional Skills & Qualifications:

• 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.
• 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.