Manufacturing Engineering Manager

Forj Medical; Saint Paul (MN); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plans

Time off programs

Annual bonus program

Job summary

Forj Medical in Saint Paul, MN is seeking a Manufacturing Engineering Manager to lead and continually improve the Manufacturing Engineering organization in support of operational excellence, product quality, customer satisfaction, and business objectives.

This role provides leadership and technical direction to Manufacturing Engineers and Technicians responsible for sustaining manufacturing operations, process optimization, equipment and automation systems, and capital projects.

Qualifications

• Bachelor of Science degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline.
• Minimum of 10 years of engineering experience, including at least 2 years of engineering leadership experience in manufacturing, process engineering, or operations support environments
• Demonstrated success leading technical teams in a regulated environment
• Strong knowledge of manufacturing processes, process improvement methodologies, and production equipment
• Experience with FDA Quality System Regulations (QSR), ISO 13485, and/or ISO 9001 standards
• Excellent communication, problem-solving, decision-making, coaching, and leadership skills

Responsibilities

• Lead, mentor, and develop a team of Manufacturing Engineers and Manufacturing Technicians to support manufacturing operations
• Establish goals aligned with operational and strategic objectives and provide coaching and career development
• Develop workforce planning and resource strategies to meet production demands
• Foster accountability and continuous improvement across the department
• Partner with Operations leadership to prioritize resources and execute objectives
• Oversee MRB activities and support corrective actions and improvements
• Provide technical leadership for processes, equipment, tooling, and automation
• Lead Lean/Six Sigma and data-driven problem solving
• Support equipment selection, qualification, maintenance, and lifecycle management
• Establish manufacturing engineering standards and documentation requirements
• Drive productivity, waste reduction, and cost reduction initiatives
• Monitor equipment utilization, process capability, and capacity for performance
• Develop and monitor manufacturing metrics and roadmaps
• Ensure compliance with regulatory requirements and quality systems
• Support validations, qualifications, and audits
• Collaborate on capital projects and budget planning

Skills

Engineering leadership

Regulated environment

Process improvement

Communication skills

Education

B.S. in Mechanical/Manufacturing/Industrial Engineering

10+ years engineering experience

2+ years leadership experience

Job description

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

Job Summary

The Manufacturing Engineering Manager is responsible for developing, leading, and continuously improving the Manufacturing Engineering organization in support of operational excellence, product quality, customer satisfaction, and business objectives. This role provides leadership and technical direction to Manufacturing Engineers and Manufacturing Technicians responsible for sustaining manufacturing operations, process optimization, equipment and automation systems, new technology implementation, capital projects, and continuous improvement initiatives. The role operates within the Operations organization and serves as a key leader in driving manufacturing performance, nonconformance timeliness, productivity improvements, and cost reduction efforts. The Manufacturing Engineering Manager partners closely with Production, Quality, Supply Chain, and Continuous Improvement to ensure manufacturing systems are safe, reliable, scalable, and capable of meeting current and future business needs.

Job Duties And Responsibilities

Manufacturing Engineering Leadership & Team Development

• Lead, mentor, and develop a team of Manufacturing Engineers and Manufacturing Technicians supporting manufacturing operations.
• Establish individual and team goals aligned with operational and strategic objectives.
• Provide ongoing coaching, performance management, training and career development opportunities.
• Develop workforce planning and resource strategies to support production demands and long-term growth objectives.
• Foster a culture of accountability, continuous improvement, collaboration, and operational excellence.
• Partner with Operations leadership to effectively prioritize resources and execute department objectives.
• Oversee activities associated with the Material Review Board (MRB) area and support disposition processes, corrective actions, and continuous improvement initiatives.

Manufacturing Process & Equipment Leadership

• Provide technical leadership for manufacturing processes, equipment, automation systems, tooling, fixtures, and production technologies.
• Lead process optimization efforts using Lean Manufacturing, Six Sigma, and data-driven problem-solving methodologies.
• Support equipment selection, implementation, qualification, validation, maintenance strategies, and lifecycle management.
• Establish and maintain manufacturing engineering standards, best practices, and documentation requirements.

Operational Excellence & Continuous Improvement

• Lead initiatives focused on productivity improvement, waste reduction, labor optimization, and cost reduction.
• Drive continuous improvement activities across manufacturing processes and supporting systems.
• Identify opportunities to improve equipment utilization, process capability, capacity, and overall operational performance.
• Support development and execution of strategic manufacturing technology roadmaps.
• Participate in value stream improvement initiatives and operational performance reviews.
• Develop and monitor key manufacturing engineering metrics and performance indicators.

Regulatory Compliance & Quality Systems

• Ensure compliance with applicable regulatory requirements, company policies, and quality management systems.
• Support manufacturing validations, process qualifications, and equipment qualifications as required.
• Participate in internal and external audits and support remediation activities when necessary.
• Promote a culture of quality and compliance throughout manufacturing operations.
• Ensure manufacturing engineering activities adhere to established documentation and change control requirements.

Financial & Business Performance

• Support annual operating plans, budget development, and resource forecasting activities.
• Drive cost reduction and operational efficiency initiatives.
• Monitor and manage departmental spending associated with equipment, tooling, automation, and capital projects.
• Support achievement of operational and financial objectives through effective manufacturing engineering leadership.

Qualifications

Required

• Bachelor of Science degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline.
• Minimum of 10 years of engineering experience, including at least 2 years of engineering leadership experience in manufacturing, process engineering, or operations support environments
• Demonstrated success leading technical teams in a regulated environment.
• Strong knowledge of manufacturing processes, process improvement methodologies, and production equipment
• Experience with FDA Quality System Regulations (QSR), ISO 13485, and/or ISO 9001 standards.
• Excellent communication, problem-solving, decision-making, coaching, and leadership skills.

Preferred

• Master of Science degree in Engineering or related technical field.
• Previous mechanical or manufacturing engineering management experience.
• Experience leading Class II and/or Class III medical device operations.
• Lean Manufacturing and/or Six Sigma certification.
• Experience working in a highly regulated industry such as Medical, Aerospace, Semi-Conductor or similar.

Working Conditions

• Office environment
• Manufacturing floor
• Engineering laboratory
• Machine shop environment

EEO Statement

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Employment Requirement

Must be authorized to work in the United States.

Compensation And Total Rewards Package

The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package.

• We offer health, dental, vision, 401K plans, and time off programs.
• You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.