Mechanical EngineerMorrisville, North Carolina
SUMMARY The Mechanical Engineer works alongside other hardware engineers on all activities relating to Spencer mechanical engineering efforts. The Mechanical Engineer will assist in design, development, and related activities across various projects. Ensure excellence and compliance in project execution by following effective project management and inter-departmental collaboration. Help in change management, project planning, and actively participate in continuous process improvement.
RESPONSIBILITIES - Drafting and modeling of hardware components.
- Work closely with other engineers to define new products and ensure products meet or exceed customer requirements.
- Performs hardware qualification testing of POC's
- Analyze designs, perform testing, and do feasibility studies of subsystems, assemblies, and their components to identify opportunities for design, cost, or time-to-market improvements.
- Qualifies vendors as per Spencer's specifications.
- Participates in process improvement activities.
- Creates manufacturing instructions and specifications.
- Ensures all hardware design activities are accomplished within Spencer's Quality Management System.
Requirements
REQUIREMENTS- Degree in mechanical engineering.
- 4 to 10 years' experience design and development of commercial or consumer products.
- Experience in drafting and modeling in parametric CAD software tools, SolidWorks preferred.
- Experience in Prototyping & Mockups with Plastics. (Injection Molding)
- Strong knowledge of hardware qualification testing of POC's.
- Strong interpersonal skills and innovative problem-solving skills.
- Experience working in a regulated environment
- Ability to read, understand, and execute job functions in accordance with Standard Operating Procedures
PREFERRED- Medical Device Background: Direct experience working under FDA/EMA regulatory frameworks and medical-grade quality management systems.
- ISO Standards: Familiarity with ISO 14971 (Risk Management), IEC 62366 (Medical Device), and IEC 60601 (Safety/Essential Performance).
