Senior Manufacturing Engineer

Summary of the Position

The Senior Manufacturing Engineer provides technical leadership for manufacturing processes, equipment, and product transfers to support development, commercialization, and sustaining operations. This role is responsible for developing, implementing, and continuously improving manufacturing processes that ensure product quality, regulatory compliance, operational efficiency, and scalability. The Senior Manufacturing Engineer serves as a subject matter expert for complex manufacturing challenges, leads cross-functional improvement initiatives, and provides technical guidance to manufacturing, quality, supply chain, and product development teams.

Manufacturing Process Leadership

• Lead the development, qualification, optimization, and continuous improvement of manufacturing processes.
• Establish and maintain process controls, tooling strategies, operating parameters, and validation approaches to ensure consistent product quality and performance.
• Provide technical leadership and support to manufacturing operations for process capability, efficiency, and compliance initiatives.
• Support manufacturing planning and process improvements across development, transfer, launch, and sustaining activities.

Product and Process Development

• Lead development and optimization of manufacturing processes to meet quality, cost, delivery, and regulatory requirements.
• Define and execute process characterization studies, DOE activities, and process capability assessments.
• Provide manufacturing expertise during product development to support design-for-manufacturability, scalability, and robust process performance.
• Collaborate with cross-functional teams to ensure manufacturing requirements are incorporated into product and process designs.

Manufacturing Transfer and Scale-Up

• Lead manufacturing transfer activities from development to production and between manufacturing sites or contract manufacturers.
• Develop and execute qualification plans, readiness assessments, and production ramp-up activities.
• Support technical engagement with contract manufacturing partners to ensure alignment with manufacturing and quality requirements.
• Establish transfer criteria and manufacturing readiness requirements for new products and processes.

Sustaining Engineering and Continuous Improvement

• Lead investigations and resolution of complex manufacturing issues, non-conformances, and process deviations.
• Define corrective actions and risk mitigation strategies for recurring or systemic manufacturing issues.
• Develop and implement improvements that enhance yield, reliability, throughput, and process robustness.
• Utilize data-driven approaches to identify and execute continuous improvement opportunities.

Tooling, Equipment, and Validation

• Define requirements and specifications for manufacturing equipment, tooling, fixtures, and automation systems.
• Lead equipment and process qualification activities, including IQ, OQ, and PQ protocols and execution.
• Ensure manufacturing processes and systems remain in a validated and compliant state.
• Support capital equipment selection, implementation, and lifecycle management activities.

Cross-Functional Leadership

• Lead technical alignment activities across Manufacturing, Quality, Regulatory, Supply Chain, Operations, and R&D.
• Represent Manufacturing Engineering in design reviews, program reviews, change control reviews, and leadership discussions.
• Mentor Manufacturing Engineers, Technicians, and cross-functional team members in manufacturing best practices and problem-solving methodologies.
• Coordinate cross-functional efforts required to achieve project and operational objectives.

Documentation and Compliance

• Develop and maintain manufacturing documentation, including procedures, work instructions, validation protocols, reports, and technical assessments.
• Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and internal quality system procedures.
• Support change control, risk management, process validation, and audit readiness activities.
• Drive consistent application of engineering, validation, and quality system practices.

Supervisory Responsibilities

Provide technical leadership, mentorship, and direction to Manufacturing Engineers, Process Technicians, and Manufacturing Technicians. May lead project teams or coordinate technical activities across multiple functional groups. Serves as a technical resource and mentor for less experienced engineering staff. Does not typically have direct people-management responsibility but may provide project leadership and technical oversight.

Qualifications

• BS in an Engineering discipline such as Industrial or Mechanical.
• Minimum of 6 years of medical device manufacturing experience required.
• Advanced degrees in engineering, biomedical sciences, or related fields will be considered for reduced experience requirements.
• SolidWorks experience required.
• Experience with equipment, tooling, and fixture design.
• Experience with root cause analysis and problem-solving tools for both technical and process issues.
• Knowledge of Lean and Six Sigma tools.
• Working knowledge of cGMP requirements for medical device manufacturing per FDA QSR and ISO 13485.