Sr. Design Quality Engineer

Core Responsibilities

• Execute quality assurance activities throughout product design and development in accordance with applicable regulations, standards, and company procedures.
• Support the development, maintenance, and review of design control deliverables.
• Support implementation and maintenance of the electronic Quality Management System (eQMS), including management of design inputs, risk management documentation, and other quality and product records.
• Author, review, and drive verification and validation activities, including protocols, reports, and closure documentation.
• Author and/or support test method validation activities, including Gauge R&R studies, Attribute Agreement Analysis, and software tool validation.
• Author, review, and drive risk management activities, including Risk Management Plans, Hazard Analyses, FMEAs, and Risk Management Reports.
• Collaborate with cross-functional teams to ensure design control activities are executed in accordance with company procedures and applicable regulatory requirements.
• Support Quality Management System (QMS) compliance, continuous improvement initiatives, and audit readiness activities.
• Support compliance activities related to medical device software lifecycle processes (IEC 62304) and usability engineering (IEC 62366-1).
• Work effectively within small, cross-functional teams while managing multiple priorities and assignments.
• Travel up to 10% as required.

Education, Experience And Background Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 7+ years of experience in Quality Engineering, Design Quality Engineering, or product development quality roles within the medical device industry.
• Strong experience supporting design controls, risk management, and verification & validation activities.
• Experience working in a startup or fast-paced product development environment preferred.

Job Req Type

Experienced

Required Travel

Yes, 10% of the time

Shift Type

1st Shift/Days

Expected Wage Range

$95,600 to $131,450

Discretionary Performance-Based Bonus

This position includes a discretionary performance-based bonus which is based on personal and company factors.

Benefits

• Medical, vision and dental coverage
• 401k
• Paid vacation
• Holidays
• Sick time
• and other benefits.