Mechanical Design Engineer II – Medical Device
Location: Lafayette, Colorado (Fully onsite)
Employment type: W2 contract
Duration: 12 months
Technical Skills
- Working knowledge of regulatory requirements for medical product development, including FDA QSR, IEC 60601, ISO 13485, 14971, 62304, MEDDEV and other regulatory agencies.
- Experience with 3‑D modeling software (CREO and/or SolidWorks).
- Experience designing and developing mechanical and electromechanical assemblies.
- Design skills including drafting standards, design progression, GD&T per ASTM Y14.5, DFSS/DFMA, tolerance analysis, and DFMEA methodologies.
Education & Experience
Education required: Bachelor of Science in Mechanical Engineering.
Years of experience required: 2 years.
Responsibilities
- Research, plan, design, verify, validate, and develop mechanical and/or electromechanical products and systems (metals, instruments, controls, plastics, robots, engines, machines, resonant, hydraulic, heat transfer systems).
- Recommend technology options or approaches to improve safety, performance, efficiency, or cost.
- Transfer designs from R&D to manufacturing as needed.
- Deliver and/or manage projects from design to implementation, working with stakeholders.
Required Knowledge and Experience
Practical knowledge and demonstrated competence within the job area, typically obtained through a university degree and at least 2 years of relevant experience.
Seniority Level
Mid‑Senior level
Job Function
Engineering, Design, and Manufacturing
Industries: Engineering Services, Medical Equipment Manufacturing, Medical Practices