Mechanical Engineer, Senior

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:

Mechanical Engineers at Forj Medical apply standard operating procedures and in-depth knowledge of mechanical engineering best practices, standards, and technologies to design, develop, test, and support medical device systems. They collaborate cross-functionally to advance products from concept through development and into production.

Senior Mechanical Engineers operate with minimal technical supervision and are responsible for delivering milestones on projects of moderate to high complexity, as directed by the Program Manager. They are assigned substantial technical responsibilities, often requiring creativity, sound engineering judgment, and independent decision-making.

Senior Mechanical Engineers may serve as the technical authority in their area of expertise, lead projects or major subsystems, and provide guidance and mentorship to junior engineers and technicians.

Job Duties and Responsibilities:

• Design and evaluate a wide range of electromechanical medical devices, including systems involving instrumentation, fluid management, motion control, pneumatics, and power transmission
• Collaborate with human factors engineers, industrial designers, usability experts, clinicians, and external partners to develop innovative, clinically relevant products
• Design plastic, metal, and machined enclosures in compliance with applicable international standards and regulatory certification requirements
• Research, develop, and evaluate electromechanical components, assemblies, fixtures, and equipment; support supplier selection and qualification
• Participate in and lead design reviews, technical analyses, project definition, and cost and schedule estimating
• Apply statistical methods to assess manufacturability, reliability, and process capability
• Utilize tools such as hazard analysis, DFMEA, and other risk management methods to ensure product safety and regulatory compliance
• Define and perform feasibility, evaluation, verification, and validation testing
• Provide technical direction to internal and external engineering support personnel
• Collaborate with manufacturing and suppliers to define assembly processes and ensure design for manufacturability and scalability
• Design, build, and validate test and manufacturing fixtures
• Provide sustaining and consulting engineering support to manufacturing and post-market activities
• Develop task estimates to support project planning, proposals, and resourcing activities
• Lead and support continuous improvement and engineering process initiatives
• Lead the analysis, evaluation, and selection of design alternatives
• Prepare, review, and maintain design documentation, test plans, and reports
• Lead requirements definition, decomposition, allocation, and traceability activities
• Support and consult on test execution and data interpretation
• Mentor, train, and support the technical development of engineers and technicians
• Ensure compliance with internal design controls, quality system requirements, and applicable regulations
• Interface with customers and collaborate with business development as needed

Qualifications and Requirements:

• Bachelor's degree in Mechanical Engineering, Physics, or a related field (or equivalent experience)
• Minimum of 6-9 years of experience with a BS degree or 3-6 years with an MS degree
• Expert-level understanding of mechanical design, detailing, prototyping, design for manufacturability, production processes, and testing for Class II and/or Class III medical devices
• Demonstrated ability to solve complex mechanical problems efficiently and effectively
• Strong technical documentation and reporting skills
• Excellent written and verbal communication skills
• Proven project planning, organization, and technical leadership capabilities
• Medical device industry experience preferred but not required

Working Conditions and Requirements:

• Office Environment
• Manufacturing 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…