Senior Design Assurance Engineer

We are hiring a Senior Design Assurance Engineer for competitive pay and a full benefits package. The role involves design quality input and deliverables for new product development programs throughout the product lifecycle. The successful candidate will support sustaining activities for investigational and commercial device manufacturing, ensuring a continuously accurate and compliant Design History File.

Requirements

• Project core team member accountable for product development deliverables including Design Controls, Risk Management, Equipment and Material Qualification, Test Method development and validation, and Design History Files
• Draft, collaborate, and approve product development deliverables and engineering work orders
• Consult and provide guidance on biocompatibility testing per ISO 10993 or collaborate with outside Contract Research Organization
• Coordinate and execute, as necessary, testing in support of new product development
• Support the transfer of designs from R&D to manufacturing
• Create and maintain up-to-date product Design History Files (DHF)
• Advise project teams and lead by example in best-practices for Quality and Regulatory compliance
• Proactively identify redundancy and opportunities for efficiency in Quality System requirements
• Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are appropriately documented and executed with a lens towards design, risk, and regulatory compliance
• Receive, investigate, and document product complaints, interacting with customers as applicable
• Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs
• Drive Product Lifecycle Management (PLM) architecture and changes, as needed

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!