Mechanical Engineer II

Position Summary

The Mechanical Engineer II 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 Duties 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.
• Design, analyze, prototype, test and troubleshoot mechanisms and cosmetic parts using a variety of digital design tools, with emphasis on design best practices and compliance with relevant regulatory requirements.
• Use equipment such as 3D printers, lasers, manual and CNC mills to prototype parts and instruments for test with strain gages, etc.
• Contribute to product risk analysis, usability, verification, and certification test efforts in pursuit of medical product certifications.
• Oversee development of prototypes and fabrication of working electromechanical mockups.
• Incorporate requirements of Leadership, Product Development, Clinical Verification, Quality/Regulatory, and Certification teams to understand and communicate project challenges and develop innovative solutions.
• Interface with 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 propose and implement corrective actions.
• Identify and escalate 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 systems control and mechanical 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, processors, com ic, etc.)
• Recognize and target potential areas for IP protection and work with legal team to develop patent applications.
• Participate in ISO and AAMI standards development.
• Maintain consistent messaging throughout including professional communication deliverables.

Required Experience

• Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related field required.
• 3 - 5 years of experience designing products in the medical, consumer, automotive, or aerospace industry.
• 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 with 3D design and analysis tools and prototype production technology.
• 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 embedded firmware preferred.
• 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 is 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.

Required Skills & Abilities

• Exceptional 3D CAD skills (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 the 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 25% (Domestic and International)