What are the responsibilities and job description for the Senior Engineer position at Accordance Search Group?
Position Summary:
Our client is seeking a Senior Engineer to drive cost-improvement and sustaining engineering initiatives. In this role, you will lead engineering changes, new product introductions, line extensions, and system improvements across the project life cycle—from planning and design to execution and delivery.
Key Responsibilities
- Project Leadership: Serve as Project Lead for material and packaging changes, line extensions, and product modifications.
- Design & Quality Control: Execute product updates using Change and Design Control processes, ensuring compliance with Class I and II medical device regulations. Maintain design history files and lead design verification/validation testing.
- Manufacturing Support: Lead manufacturing trials, coordinate material testing, investigate quality complaints, and author work instructions for design transfer.
- Continuous Improvement: Apply Lean tools to drive business process improvements and lead cost-analysis initiatives.
- Cross-Functional Collaboration: Partner with global manufacturing sites, present project updates to stakeholders, and mentor junior team members.
Qualifications & Experience
- Education: Bachelor’s Degree in Engineering (Mechanical, Biomedical, or Material Science preferred).
- Experience: 3–5 years of engineering experience, including 2–3 years of demonstrated project management.
- Regulatory/Technical Knowledge: Familiarity with robust quality management systems, risk mitigation, and Class I/II medical devices (preferred).
- Software: Working knowledge of SolidWorks or AutoCAD, alongside proficiency in Microsoft Office and ERP systems.
- Certifications: Lean Six Sigma Green or Black Belt certification is a plus.