Senior Mechancal Design Engineer

Agiliti; Wauwatosa (WI); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health insurance

401K matching

Paid Time Off

Tuition Reimbursement

Employee discounts

Job summary

Agiliti is seeking a Senior Mechanical Engineer to lead multiple complex projects in collaboration with stakeholders across Engineering, Quality/Regulatory, and Certification teams. You will drive design from kickoff to implementation, ensuring cost, schedule, and performance goals are met with robust 3D CAD models and rigorous design review processes.

You will oversee prototype fabrication, tooling reviews, and production transfer while maintaining high standards for regulatory compliance and

Qualifications

• Proven track record leading complex medical device projects
• Experience with ISO/IEC/FDA standards for certifications
• Ability to travel up to 50% (Domestic and International)
• Experience with mass production processes (injection molding, etc.)
• Proven collaboration across multiple disciplines and teams

Responsibilities

• Act as technical lead on multiple complex, integrated projects
• Ensure system integration across projects
• Develop innovative design processes meeting quality, cost and delivery goals
• Create electro-mechanical designs using 3D CAD tools
• Contribute to risk analysis, usability, verification and certification
• Oversee prototype development and fabrication of working models
• Communicate project challenges to cross-functional teams and leadership
• Review tooling designs and support transfer to mass production
• Design and review fixtures and production samples; analyze field returns for root cause
• Guide team leaders and raise issues/risks with cross-functional management
• Lead project update presentations and design reviews with visuals

Skills

3D CAD

Inventor

SolidWorks

FEA

DFMEA

Regulatory standards

Communication

Travel up to 50%

Education

BS Engineering

Tools

Jira

Monday.com

Todoist

Job description

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 raise 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 and developing effective solutions.
• Strategic Perspective – Needs to keep overall objectives and strategies in mind, and not be deflected by matters of detail.
• Applying standards – Effective in the application of relevant industry and process standards to all tasks undertaken.
• Industry Developments – Must take initiative to ensure skills and specializations are kept up to date in line with industry developments and ensure that all relevant skill sets are current.
• Ability to manage client needs and relations effectively.
• Ability to travel up to 50% (Domestic and International)

It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws. In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities. Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agiliti’s investigation of such reports. Affidatory Action Policy Statements

You may be required to obtain certain vaccinations, or provide proof of current vaccination status, based on customer and/or company requirements. If vaccination is required, Agiliti will provide specific directions and cover the expense at a participating clinic. Please note, this includes the COVID-19 vaccination.

Agiliti offers a robust suite of benefits for regular, full-time, non-union employees including: health insurance options for Medical, Dental & Vision plans, Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs.

Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law.

Primary Job Location

Milwaukee Design Center

Job Title

Sr Mechanical Engineer

Company

Agiliti

Location City

Wauwatosa

Location State

Wisconsin