Sr. Design Assurance Engineer

Location: Marlborough, MA
Salary: $120,000.00 USD Annually - $145,000.00 USD Annually
Description:
The Judge Group is seeking a Senior Design Assurance Engineer for a full time opportunity with a Medical Device Manufacturer. This role will be fully onsite in Marlborough, MA

Candidates should be strong with the following related to disposables or capital medical equipment:

• Design Controls
• Product Requirements
• Testing
• Risk management
• Design Validation
• Internal Design controls
• Strong Documentation

Responsibilities:

• Conduct product design control activities for both new and sustaining product development initiatives.
• Support risk analysis activities, including design and process Failure Modes and Effects Analysis (FMEA).
• Assist with Process/Design Validation/Verification tasks, encompassing software validation and Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) activities.
• Collaborate with Design Engineering to create and maintain Design History and Technical Files.
• Coordinate with third-party testing facilities for compliance testing of IPG products.
• Aid the regulatory department with FDA, CE, and other regulatory submissions.
• Execute all other essential duties as assigned.

Requirements:

• Bachelor's Degree in a scientific or engineering field.
• Minimum of 8 years in an engineering or quality role within the medical device industry.
• Strong understanding of Design Controls and Risk Management practices, regulations, and standards (e.g., FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, 62304) is preferred.
• Experience supporting medical device compliance testing (e.g., EMC, EMI, IEC) with external testing facilities, such as TV and Intertek.
• Proficiency in maintaining technical design documentation (e.g., design specifications, verification/validation protocols, DFMEA/PFMEA).
• Knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability analysis, tolerance interval analysis, power and sample size determinations), preferably with statistical software tools such as Minitab.
• Familiarity with lasers and optical technologies is desired, but not essential.

Contact:

This job and many more are available through The Judge Group. Please apply with us today!

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