Independently conducts root cause investigation, design solution identification, and design solution implementation work as part of a major research and/or development project. Receives minimal technical direction/review on broad scope or complex projects.
Key Responsibilities Solve engineering problems by analyzing the situation and recommending corrective or alternative actions. Lead the design & execution of structured experimental plans to drive data-based decisions. Create and update drawings, BOM’s, and other design outputs. Support Design Change Assessments (DCA’s) for Capital Equipment. Develop and update test methods for evaluating product requirements and design specifications. Write and execute protocols/reports for Design Verification. Provide clear communication to stakeholders. Leverage internal/external partners to achieve project objectives. Work cooperatively with Process Development, Quality, Manufacturing, Regulatory, Clinical, and Marketing on complex projects to ensure project success. Create a strong team culture around high expectations & high performance. In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to all documented quality processes and procedures.
Quality Systems Duties and Responsibilities:Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Minimum Qualifications:
Bachelor’s degree in mechanical, Biomedical, or similar Engineering.
Bachelor’s Degree with 6+ years, OR Master’s Degree with 5 years or more experience. Strong mechanical engineering skills, specifically with machined, sheet metal and injection molded component design for manufacturability and assembly. Solid medical device or regulated industry design control process and documentation experience (i.e. – Windchill). Excellent organizational, communication, and collaboration skills. 2 years' experience with SolidWorks or similar CAD software.
Must be a “self-starter” and willing to reach out to cross-functional team members.
Preferred Qualifications: Expertise in design simulation tools and analysis techniques. Experience with working with external vendors. Experience with tolerance stack up and thermal analysis. Experience with reliability and HALT testing.
- IEC 60601-1 (Product Safety) experience with Medical Devices
Job Type: Contract
Salary: $55.00 - $70.00 per hour
Application Question(s):
- Please provide your Email Address!
Education:
- Bachelor's (Preferred)
Experience:
- Manufacturing: 6 years (Preferred)
- SolidWorks or CAD: 2 years (Preferred)
- Medical device: 2 years (Preferred)
- Mechanical design: 2 years (Preferred)
- Windchill: 1 year (Preferred)
Work Location: In person