9992

Job Description

Job Title: PI Engineer (Entry Level)
Duration: 3–6 Months Contract
Rate: $30–35/hr
Work Location: Needham, MA

Key Responsibilities:

• Collaborate with cross-functional teams to ensure product quality is considered during design and prototyping phases.
• Participate in early design reviews to identify potential quality risks and provide input on manufacturability and compliance.
• Lead or assist in Design Failure Mode and Effects Analysis (DFMEA) and Process FMEA sessions in partnership with design engineers.
• Support design verification activities by reviewing test results and contributing to root cause analysis and corrective actions.
• Provide guidance on quality-related aspects of materials and manufacturing processes to optimize product reliability.
• Contribute to supplier qualification efforts by supporting material validation and feedback loops.
• Oversee the creation and review of technical documentation including Design History Files (DHF), Product Requirement Documents (PRD), and Test Protocols.
• Ensure new products comply with relevant quality and regulatory standards (e.g., FDA, GMP, ISO).
• Participate in post-launch reviews to gather feedback and identify opportunities for continuous improvement.
• Monitor and analyze quality KPIs related to new products and post-market feedback.

Qualifications:

• Bachelor’s in Mechanical or Electrical Engineering.
• 3+ years in quality engineering, preferably in consumer products.
• Expertise in DFMEA, SPC, MSA, Weibull, or related quality tools.
• Strong problem-solving, project management, and cross-functional leadership skills.
• Comfortable working in fast-paced, global environments