Senior Engineer

Accordance Search Group; Neenah (WI); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Accordance Search Group's client is seeking a Senior Engineer to drive cost-improvement and sustaining engineering initiatives. This role leads engineering changes, new product introductions, line extensions, and system improvements across the project lifecycle from planning to delivery.

The ideal candidate will have 3–5 years of engineering experience, including 2–3 years in project management, with familiarity in medical device quality systems and proficiency in SolidWorks or AutoCAD.

Qualifikationen

• 3-5 years of engineering experience, including 2-3 years of demonstrated project management.
• Familiarity with robust quality management systems and risk mitigation in medical devices.
• Proficiency with SolidWorks or AutoCAD; good MS Office and ERP skills.
• Lean Six Sigma Green or Black Belt certification is a plus.

Aufgaben

• Lead project changes for material and packaging, line extensions, and product modifications.
• Design control and verification/validation testing; maintain design history files.
• Lead manufacturing trials, coordinate material testing, and address quality issues.
• Apply Lean tools to drive process improvements and cost analyses.
• Collaborate with global sites, present updates, and mentor junior engineers.

Kenntnisse

Lean tools

Project leadership

Cross-functional collaboration

Quality mindset

Ausbildung

Bachelor's in Engineering

Tools

SolidWorks

AutoCAD

Microsoft Office

ERP systems

Jobbeschreibung

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.