Mechanical Engineering Manager

Forj Medical; Northern (KY); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Forj Medical seeks a Mechanical Engineering Manager to lead a high-performing team focused on design, development, and commercialization of innovative medical devices. You will guide Mechanical Engineers, Process Engineers, Technicians, and Designers across capital equipment, surgical navigation, and future portfolios.

You will drive technical excellence, regulatory compliance, and continuous improvement while ensuring successful product development and lifecycle support across cross-functional

Qualifications

• Bachelor's degree in Mechanical/ Manufacturing/ Industrial Engineering or related field.
• 10+ years engineering experience with at least 2 years in leadership of medical device development.

Responsibilities

• Lead a multidisciplinary team of Mechanical Engineers, Process Engineers, Industrial Designers, Technicians, and Designers.
• Drive technical excellence, regulatory compliance, and continuous improvement in product development.

Skills

Leadership

Mechanical design

Regulatory compliance

Prototyping

Project management

Cross-functional collaboration

DFX/DFM/ DFA/ DFR

Education

Bachelor of Science in Mechanical Engineering

Master's degree in Engineering (preferred)

Tools

CAD (SolidWorks/AutoCAD)

Job description

Job Summary:

The Mechanical Engineering Manager is responsible for building, developing, and leading a high-performing mechanical engineering organization focused on the design, development, and commercialization of innovative medical devices. This role provides technical and people leadership for Mechanical Engineers, Process Engineers, Technicians, and Designers supporting Capital Equipment, Surgical Navigation, and future product portfolios.

As a key member of the Development & Engineering team, the Mechanical Engineering Manager drives technical excellence, operational effectiveness, and continuous improvement while ensuring successful product development, regulatory compliance, customer satisfaction, and business performance. The ideal candidate combines strong engineering expertise with demonstrated leadership experience in regulated medical device environments.

Job Duties and Responsibilities:

Engineering Leadership & Team Development

• Lead, mentor, and develop a multidisciplinary team of Mechanical Engineers, Process Engineers, Industrial Designers, Technicians, and Designers supporting cross-functional product development programs.
• Foster a culture of innovation, accountability, collaboration, and continuous improvement.
• Establish individual and team performance objectives and provide ongoing coaching, performance feedback, and career development opportunities.
• Develop workforce planning, resource forecasts, and organizational strategies to support annual operating plans and long-term business objectives.
• Partner closely with Program Management and Operations teams to effectively allocate resources and ensure program success.
• Oversee mechanical engineering laboratories, equipment, and development support services.

Technical Leadership

• Provide expert-level guidance in mechanical system design, component and assembly development, engineering documentation, prototyping, manufacturing processes, testing, and product support.
• Lead the development of complex electromechanical medical devices, including technologies related to instrumentation, fluid management, motion control, pneumatics, optics, wearables, and power transmission systems.
• Establish and maintain engineering standards, design practices, and technical review processes.
• Ensure designs meet requirements for quality, reliability, manufacturability, serviceability, and cost-effectiveness.
• Drive Design for Excellence (DFX) methodologies, including Design for Manufacturability (DFM), Design for Assembly (DFA), and Design for Reliability (DFR).

Strategic Planning & Continuous Improvement

• Develop and execute strategies to advance mechanical engineering capabilities and support organizational growth objectives.
• Evaluate and recommend investments in engineering tools, laboratory equipment, manufacturing technologies, additive manufacturing systems, fixtures, testing capabilities, and facility improvements.
• Identify opportunities to improve engineering processes, operational efficiency, and product performance.
• Promote innovation and continuous improvement to create competitive advantages and differentiated value for customers.

Stakeholder & Customer Engagement

• Support business development activities by participating in customer meetings, technical discussions, proposal development, quotations, and Statements of Work (SOWs).
• Communicate complex technical information effectively to customers, leadership, and non-technical stakeholders.
• Collaborate with Human Factors, Software, Electrical, Industrial Design, Systems. Usability Engineering, Manufacturing, Quality, Regulatory Affairs, and Supply Chain teams throughout product development.
• Anticipate customer, manufacturing, supplier, and service needs to ensure successful product implementation and lifecycle support.
• Support supplier development initiatives and technical partnerships as required.

Product Development & Program Execution

• Ensure engineering deliverables are completed on time, within budget, and in accordance with quality and regulatory requirements.
• Support project planning, estimation, budgeting, risk management, and resource allocation activities.
• Drive cost reduction and Cost of Goods Sold (COGS) improvement initiatives.
• Apply statistical methods and engineering principles to assess manufacturability, process capability, reliability, and product performance.
• Support process qualification and validation activities, including IQ/OQ/PQ protocols.
• Ensure compliance with company policies, quality systems, and regulatory standards.

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 medical device development.
• Demonstrated success leading technical teams in a regulated environment.
• Strong knowledge of mechanical design, product development, prototyping, manufacturing processes, and product testing.
• 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 development programs.
• Knowledge of IEC 60601 and IEC 60529 standards and associated compliance testing requirements.
• Experience leading products through the full product development lifecycle from concept through commercialization.
• Experience with supplier development, process validation, and manufacturing transfer activities.
• Experience working in a highly regulated industry such as Medical, Aerospace, Semi-Conductor or similar.

Key Competencies

• Process Development Knowledge
• Strategic Leadership
• Team Development & Coaching
• Product Development
• Cross-Functional Collaboration
• Program & Resource Management
• Regulatory Compliance
• Design for Manufacturability (DFM/DFX)
• Process Validation (IQ/OQ/PQ)
• Customer Engagement
• Continuous Improvement
• Cost Reduction & Operational Excellence

Working Conditions

• Office environment
• Manufacturing floor
• Engineering development laboratory
• Machine shop environment
• Occasional travel as required to support customers, suppliers, and development activities