Senior Manufacturing Engineer

Location: Delano

Job Description

The lead Manufacturing Engineer leads the development, optimization, and support of manufacturing processes to ensure high-quality, reliable, and cost-effective production in a regulated, clean-room environment. This role focuses on translating product specifications into robust manufacturing methods, driving continuous improvement, supporting cross-functional teams, and mentoring other engineers and technicians while managing multiple high-profile projects.

Responsibilities

+ Analyze product specifications and translate them into efficient manufacturing processes that establish production rates, achieve expected quality levels, and ensure the reliability of finished products.

+ Identify tooling-related issues and collaborate closely with tool makers to resolve problems and improve tool performance.

+ Develop manufacturing methods for new and existing products, including establishing labor standards and generating accurate product cost information.

+ Meticulously document all manufacturing process information, sequences, and changes within the document control system to maintain full traceability and compliance.

+ Identify opportunities for improvement in existing processes and methods using data analysis and direct observation, then develop and implement improvements as quickly as practical.

+ Increase production rates and reduce scrap by identifying, evaluating, and implementing new or improved equipment, processes, or human factors methods.

+ Assist production teams in troubleshooting issues with individual components and processes, and implement solutions that support on-time customer deliveries and superior product quality.

+ Review production schedules and engineering specifications to resolve production problems and ensure alignment between design intent and manufacturing capabilities.

+ Act as an active member of the CAPA team, implementing permanent corrective actions to address root causes of quality and process issues.

+ Participate in determining product DMR disposition plans, collaborating with the value stream team to define and approve appropriate actions.

+ Follow ISO standards, 21 CFR Part 11 and Part 820, and internal protocols to ensure regulatory compliance and robust quality systems.

+ Plan and execute Design of Experiments (DOEs), perform structured problem solving, conduct FMEAs, support validations, and develop control plans for manufacturing processes.

+ Provide continuation engineering support for products to maintain and improve performance, quality, and manufacturability over the product lifecycle.

+ Actively support Production, Engineering, and Quality departments by providing technical guidance, process expertise, and hands-on support.

+ Mentor Manufacturing Engineers and Technicians, sharing knowledge, experience, and best practices to develop their skills and capabilities.

+ Develop ideas and strategies to improve operational efficiency, add value, enhance business performance, and foster a culture of continuous improvement.

+ Successfully manage multiple high-profile projects simultaneously, ensuring clear priorities, effective communication, and timely completion.

+ Apply Lean manufacturing and Lean Sigma tools to optimize value streams and eliminate waste in manufacturing operations.

+ Adhere to and promote Good Manufacturing Practices (GMP) and principles in all engineering and production support activities.

Essential Skills

+ Strong experience in manufacturing engineering with responsibility for developing and supporting robust manufacturing processes.

+ Proven ability to apply Lean manufacturing principles and Lean Sigma tools to optimize value streams and drive continuous improvement.

+ Hands-on experience working in a clean-room manufacturing environment.

+ Deep understanding and practical application of Good Manufacturing Practices (GMP) in a regulated setting.

+ Experience in medical device manufacturing or similarly regulated industries.

+ Demonstrated capability in process development, including establishing production rates, labor standards, and product cost information.

+ Proficiency in identifying and resolving tooling-related issues in collaboration with tool makers.

+ Strong skills in structured problem solving, including execution of DOEs, FMEAs, validations, and development of control plans.

+ Ability to meticulously document manufacturing processes and maintain accurate records within a controlled document system.

+ Familiarity with ISO standards and regulatory requirements, including 21 CFR Part 11 and Part 820.

+ Proven track record of supporting production, engineering, and quality teams in troubleshooting and resolving manufacturing issues.

+ Ability to manage multiple high-profile projects simultaneously with strong organizational and prioritization skills.

+ Effective communication and collaboration skills for working with cross-functional teams.

+ Demonstrated ability to mentor and guide engineers and technicians.

Additional

Skills & Qualifications

+ Experience…