Job Title: Senior Mechanical Engineer
Job Number: 25012
The Senior Mechanical Engineer position is responsible for the mechanical engineering activities associated with the development of medical devices. The Mechanical Engineer will design and develop new miniaturized portable and wearable products based on platform technology. The engineer will be responsible for developing, writing and executing test protocols, reports, specifications, procedures, and evaluations following FDA and other applicable medical device and combination product guidelines and standards.
- Design and develop medical devices for combination products following Design Control and Quality Management System procedures
- Select and evaluate components and materials for use in product designs
- Develop 3-D CAD models of parts and assemblies. Create drawings and component requirements.
- Review drawings and models from other engineers and designers
- Provide simulations, models, and engineering characterizations to ensure proper product performance and reliability
- Assist with systems integration and evaluation of products
- Perform and support initial and on-going design reviews
- Develop protocols and perform mechanical testing of the product
- Document development activities through schedules, lab notebook, patents, design history file, technical reports and other records in accordance with Design Control and other company procedures
- Optimize product for manufacturability and facilitate the transfer of the design to manufacturing
- Interact with and manage vendors, suppliers, and external consultants
- Support other departments as needed
- BSME degree required; MSME is a plus.
- 4+ years of related design work experience and mastery of core competencies should be consistent with the appropriate engineering job level.
- Advanced knowledge of mechanical components (molded, stamped, and machined parts) and sensors (pressure, and load sensors).
- Experience in molded thermoplastic material enclosure and joining design.
- Experience in mechanical actuating and latching mechanism design preferred.
- Experience with fluidics system design preferred
- Proficiency with CAD software required, SolidWorks strongly preferred
- Understanding of design rules for meeting industrial / electrical compliance standards such as UL and CE.
- Familiarity with Lean tools and their application to support Engineering processes (FMEA, HK, A3PS).
- System modeling and simulation experience required, fluidics and thermal experience preferred
- Ability to work under tight deadlines with measurable milestones
- Strong collaborative and communication skills
- Must be detail-oriented