Senior Manufacturing Engineer

This is a fully remote position, open to applicants in Nevada.

📋 Description

• Strategically oversee and prioritize multiple simultaneous projects and objectives, ensuring optimal resource allocation and alignment with the organization’s goals.

• Lead and facilitate design reviews, offering expert guidance across cross-functional teams (R&D, QA, OPS) to foster innovation and ensure adherence to regulatory standards.

• Identify, advocate for, and implement enhancements to processes and procedures to boost manufacturing efficiency, product quality, and compliance with regulations.

• Promote and integrate lean manufacturing principles across the organization, fostering a culture of continuous improvement and operational excellence.

• Supervise the creation and upkeep of thorough product documentation, which includes component specifications, BOMs, CAD models and drawings, manufacturing instructions, and lot history records.

• Direct the development, maintenance, and enhancement of manufacturing equipment, tooling, and fixtures, ensuring their reliability and scalability.

• Author, execute, and oversee test protocols, analyze test data, and prepare comprehensive test reports to support validation and verification processes.

• Lead efforts in process validation and equipment qualification, ensuring that all manufacturing processes comply with regulatory and quality standards.

• Develop and manage detailed project schedules to guarantee the timely achievement of milestones and deliverables.

• Monitor manufacturing production yield and throughput; proactively identify challenges and implement solutions to enhance performance and reduce disruptions.

• Establish, monitor, and assess key performance indicators for manufacturing processes to drive data-informed decision-making and continuous improvement.

• Provide leadership and guidance to the assembly team, nurturing a culture of quality, consistent manufacturing output, and high yields.

• Travel periodically as necessary to support project deliverables, conduct supplier audits, and fulfill organizational needs.

• Initiate and supervise Document Change Orders and Nonconformance Material Reports activities; actively engage in Corrective and Preventive Actions as required.

⛳️ Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering preferred; certifications in leadership or medical device design are highly regarded.

• A minimum of 7 years of engineering experience, preferably in regulated industries, with a proven track record of leadership in cross-functional teams and projects.

• Strong interpersonal and collaborative abilities; capable of mentoring teams and communicating effectively; an expert problem solver.

• Proficient in SolidWorks CAD for intricate fixture and tooling design, overseeing reviews and implementation across projects.

• Extensive knowledge of materials and processing methods; skilled at optimizing for performance, manufacturability, and compliance.

• Advanced training in GMP and ISO 13485; experienced in sustaining quality systems and driving improvements.

• Lean Six Sigma expert with a history of successfully leading process improvements and team training.

• Proactive in identifying and addressing technical and operational challenges, ensuring effective corrective actions across departments.

• Significant experience in clean room (CER) operations, including staff training and compliance leadership.

• Capable of performing basic movements and tasks; comfortable with exposure to manufacturing materials.

🏝️ Benefits

• Medical

• Vision

• Dental

• 401k Matching

• Employee Assistance Programs

• Paid time off