Senior Manufacturing Engineer

About the role

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.
• Aid 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.
• Experience 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.
• Meticulous documentation of manufacturing processes and maintenance of 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 leading or actively participating in CAPA activities and implementing permanent corrective actions.
• Experience participating in DMR disposition decisions as part of a cross-functional value stream team.
• Experience developing and implementing strategies that improve operational efficiency and overall business performance.
• Strong analytical skills and the ability to use data and observation to identify process improvement opportunities.
• Experience in human factors considerations to enhance productivity and reduce scrap.
• Interest in and commitment to fostering a culture of continuous improvement.
• Eligibility for participation in a bonus program, reflecting performance and company results (as applicable to this role).