Job SummaryMechanical 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 - Office environment
- Manufacturing environment
Compensation- The expected starting salary for this position is $100,000 to $135,000 depending on qualifications. As part of your overall rewards, we offer a comprehensive benefits program.
