Mechanical Engineering Manager

Forj Medical; Saint Paul (MN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401K plan

Paid time off

Job summary

Forj Medical in Minnesota seeks a Mechanical Engineering Manager to build and lead a high‑performing team focused on design, development, and commercialization of medical devices.

You will guide engineers and designers, ensure regulatory compliance (FDA QSR, ISO 13485), and drive continuous improvement across programs from concept to launch.

This role requires a strong technical leader with 10+ years in regulated environments, plus mentoring, budgeting, and cross‑functional collaboration.

Qualifications

• Bachelor of Science in Mechanical Engineering or related field.
• Minimum 10 years of engineering experience including at least 2 years in engineering leadership 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 QSR, ISO 13485, and/or ISO 9001 standards.

Responsibilities

• Lead, mentor, and develop a multidisciplinary team supporting cross-functional product development programs.
• Foster a culture of innovation, accountability, collaboration, and continuous improvement.
• Develop workforce planning, resource forecasts, and organizational strategies to support business objectives.
• Partner with Program Management and Operations to allocate resources and ensure program success.
• Oversee laboratories, equipment, and development support services.

Skills

Engineering leadership

Team development

Regulatory knowledge

Mechanical design

Project management

Communication

Prototyping

Education

Bachelor of Science in Mechanical Engineering

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 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 environmentOccasional travel as required to support customers, suppliers, and development activities

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.