Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing medical professionals the most valuable and complete solutions to enhance patient care.
As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostic products, IL is supported by significant resources, outstanding scientific expertise and a tremendous knowledge base. IL is headquartered in Bedford, MA, USA.
The R&D Staff Mechanical Engineer applies intensive and diversified knowledge of engineering principles and practices in the areas of mechanical design. The R&D Staff Mechanical Engineer is responsible for complex assignments requiring the development of new or improved techniques and procedures, as well as for the modification and extension of theories, precepts and practices. The R&D Staff Mechanical Engineer uses advanced techniques to complete projects that are expected to result in the development of new or refined equipment, processes, products and methods.
- Use 3D Solidworks to design and analyze medical products and test fixtures and conduct tolerance analysis.
- Perform model optimization using tools like ANSYS.
- Analyzes requirements, specifications, and design documentation.
- Creates and executes test plans and procedures and assist with hardware debugging as needed.
- Participates in hardware development activities, such as performing hazard and risk analysis, assisting with requirements and design, and conduct design reviews, etc.
- Generates high-quality work products (documents, test plans, test reports, manufacturing drawings).
- Interfacing with the Company's SAP and CAD PLM systems to manage projects in our design control environment.
- Develops test strategy and procedures based on product and/or hardware requirements.
- Creates verification reports and overall verification summary reports.
- Plan and schedule work in relation to general program schedule.
- Provide technical leadership to project teams.
- Prepare and/or assist in the preparation of technical reports and documentation.
- Provide recommendations for new product development.
- Contribute to scientific discussions pertinent to the company's products and developmental goals.
- Bachelor's degree or higher in Mechanical Engineering preferred, plus a minimum of eight (8) years previous experience, preferably within a regulated medical device environment.
- Experience with Solidworks data management, 3D modeling, design and tolerance stack-up analysis.
- Experience with tooling for injection molded and sheet metal parts.
- Experience with robotics, opto-electrical, microfluidic dynamics, and/or heat transfer is required.
- Excellent interpersonal, communication, presentation and cross functional influencing skills.
- Demonstrated experience with implementing product changes through a structured, phase-gated, product development process. Good understanding of medical device product development risk management highly desirable.
- Ability to make practical assumptions with engineering justifications, where needed.
- Six Sigma and proficiency with basic statistical techniques including familiarity with FMEA and design of experiment (DOE) methodologies is desirable.
- Ability to analyze, organize and present large amounts of data in a clear and concise manner.
- Disciplined and well organized in documentation in a regulated environment.
- Ability to execute concurrently multiple projects and manage priorities.
- Ability to work independently as well as delegate appropriately.
- Strong sense of accountability and action-oriented self-starter attitude.
- Ability to set direction, align goals, lead and influence others in a matrix organization.
- Ability to mentor and coach junior members in the organization.
- Experience with computational fluid dynamics.
- Experience with high volume consumable production industry.