Senior Mechancal Design Engineer

agiliti; Milwaukee (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

agiliti seeks a Senior Mechanical Engineer to lead cross-functional medical product development, managing scope, goals, and deliverables from kickoff to implementation.

The role emphasizes robust design using SolidWorks or Inventor, DFMEA, and adherence to ISO/AAMI/FDA standards, with prototype creation, testing, and collaboration with Quality/Regulatory teams.

Qualifications

• BS in Engineering required.
• 10+ years of product design in medical/industrial sectors.
• Experience with ISO/IEC AAMI UL CE and FDA certifications.
• Experience leading collaborative cross-functional teams.

Responsibilities

• Act as technical lead on multiple complex, integrated projects.
• Develop and drive an innovative design process for quality, cost, and delivery.
• Create electro-mechanical designs using 3D CAD with regulatory compliance.
• Support product risk analysis, verification, and certification efforts.

Skills

Analytical thinking

Interpersonal communication

Presentation skills

Project coordination

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Autodesk Inventor

FEA tools

Job description

SUMMARY

The Senior Mechanical Engineer will work in collaboration with all stakeholders, manage overall project scope, goals, and produce deliverables that support business objectives. This position will lead multiple parallel initiatives from kickoff through successful implementation. They will partner with Strategic Corporate leaders, Engineering, Quality/Regulatory, and Certification teams to drive project design, facilitate best practices, and ensure cost, financial, schedule and performance goals are met.

PRIMARY OBJECTIVES AND RESPONSIBILITIES

• Act as technical lead on multiple complex, integrated projects utilizing advanced engineering design methods.
• Ensure systems integration and continuity of system architecture roadmap across multiple discrete projects.
• Develop and drive an innovative design process to ensure development activities meet standards for quality, cost, and delivery.
• Create electro-mechanical part and assembly designs using parametric 3D CAD tools, with emphasis on mechanical function, structural analysis, aesthetic design, intent implementation, and compliance with relevant regulatory requirements.
• Contribute to product risk analysis, usability, verification, and certification test efforts in pursuit of medical product certifications.
• Oversee development of prototype mockups and fabrication of working prototypes.
• Incorporate requirements of Leadership, Product Development, Clinical Verification, Quality/Regulatory, and Certification teams to understand and communicate project challenges and develop innovative solutions.
• Review tooling designs to verify the quality of fit and finish implementation as well as supporting manufacturing partners to resolve issues during design transfer and transition to mass production.
• Design and review manufacturing test fixtures and procedures, review and approving initial production samples, analyze and test field returns to determine root cause of failure and proposing and implementing corrective actions.
• Guide team leaders throughout the project by delegating tasks and providing coaching as needed.
• Identify and elevate issues/risks facing Product Development Teams and work with cross functional management teams to develop solutions.
• Organize and lead project update presentations and design reviews, preparing visual materials for describing complex engineering concepts (such as screenshots, photos and videos) for internal team, supplier and sales/marketing communication.
• Continuously improve the process by researching and proposing innovative technology enablers (e.g. materials, components, and processes)
• Recognize and target potential areas for IP protection and work with legal team develop patent applications. .
• Participate in ISO and AAMI standards development.
• Maintain consistent messaging throughout including professional communication deliverables.
• This job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department.

QUALIFICATIONS

• Bachelor's degree (BS) Engineering required.
• 10+ years of experience designing products in the medical, consumer, automotive, or aerospace industry.
• Proven versatility in both large and small entrepreneurial organizations as demonstrated by succession in responsibilities and willingness to scale abilities to complete objectives.
• Experience in creating and leading collaborative teams through complex projects.
• Familiarity with other technical disciplines such as EE and Software preferred.
• Understanding of and familiarity with mass production manufacturing processes for consumer products, including injection molding, blow molding, welded steel structures, sheet metal stamping and forming, die casting, and CNC technologies.
• Experience in DFM, DFA, DFMEA, or other risk based design strategies.
• Experience designing for agency certifications (e.g. ISO, IEC, AAMI, UL, CE, CISPR, FCC, FDA) required. Prior experience with the 60601 family or other FDA related standards a significant plus.
• Prior experience interfacing with Certification bodies (Intertek, UL, TUV) preferred.
• Prior experience working with project management software and Scrum type environments (Jira, Monday, Todoist, etc.).
• Demonstrated financial acumen.
• Strong interpersonal communication and presentation skills.
• Experience in Healthcare product development or similarly Federally regulated field.

KNOWLEDGE, SKILLS AND ABILITIES

• Exceptional 3D CAD skills (Inventor or SolidWorks) for creating robust parametric models; top-down "master model"-driven assemblies.
• Experience using computational tools for structural analysis (FEA) and dynamic mechanical performance a significant plus.
• Analytical Thinking - Capable of understanding a technical problem or situation