Mechanical Engineer, Senior

Forj Medical•Saint Paul, MN

19d

About The Position

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.

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
Must be authorized to work in the United States.

Nice To Haves

Medical device industry experience preferred but not required

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