The Company

SpectraWAVE is a commercial stage fast-paced medical device start-up, with a mission to provide unrivaled optical and computational insights to improve treatment and outcomes for patients with coronary artery disease – the number one cause of mortality in the world. SpectraWAVE’s flagship HyperVue™ Imaging System combines next generation intravascular imaging and advanced machine learning algorithms to support and optimize coronary stenting procedures in the catheterization lab and serves as a central hub for future enhancements that will continue to empower interventionalists in their treatment decision making and optimization. The company has received FDA clearance for the HyperVue Imaging System and is commercializing its products in the U.S. market. The team is a small and passionate group of talented innovators and healthcare professionals who strive every day to make a direct impact on patients’ lives.

Job Summary

As a Senior Quality Engineer, you'll play a crucial role in ensuring the production quality of our flagship products, which include sophisticated electromechanical medical devices with software and single-use disposables. Your primary goal is to improve and maintain product quality, drive compliance and drive manufacturing excellence, and support delivery of high-quality, reliable products on time.

Key Responsibilities

• Own product and process non-conformances in production to improve and maintain product quality and reliability and ensure timely closure of non-conformances.
• Take ownership of incoming inspection of material and sub-assemblies, including assisting QC lnspector(s) in inspection activities and maintenance of quality records.
• Manage equipment calibration and preventive maintenance programs for all controlled equipment at the company, including overseeing cleanroom cleaning and environmental monitoring activities.
• Lead and support continuous quality improvement activities within manufacturing, fostering collaboration with suppliers to drive resolution for non-conformances.
• Provide quality control support to manufacturing and R&D departments.
• Assist in developing and executing equipment qualifications protocols and support process validation as applicable.
• Actively participate as an auditor in external supplier audits and internal audits
• Lead and support device failure analysis for prompt evaluation and closure of nonconformances, CAPAs, and customer complaints.
• Track, trend, and analyze manufacturing yield for catheters and sub-assemblies to identify opportunities to implement process controls to improve product quality.
• Generate timely product non-conformance reports for senior management.
• Enhance quality system processes related to all manufacturing activities, including acceptance activities, identification and traceability, handling, and storage of material and finished devices.
• Perform other duties as required.

Requirements

Minimal Qualifications

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
• Bachelor's degree in a science/engineering discipline.
• Minimum 3 years of recent experience supporting production as a Quality/Manufacturing Engineer in the medical device industry, with a focus on quality and equipment control, incoming inspection, equipment qualification, and process validation.
• Experience with complex medical systems containing software, hardware, and disposables.
• Working knowledge of lSO 13485, lEC 62304, Medical Device Directive/Regulation, and 21 CFR Part 820 requirements.
• Strong experience with creating QMS policies and work instructions.
• Must have a strong understanding of quality system requirements and how each quality system element connects to another.
• Experience managing projects and project deliverables to completion.
• Comfortable working independently and as part of a cross-functional team.
• Ability to manage multiple priorities.
• Must be a self-starter and a fast learner.

Preferred Qualifications

• Master's degree in a science/engineering discipline.
• Auditing certification (lSO 13485, MDSAP, EU MDR).
• American Society for Quality (ASQ) Certification (i.e., CQA, CQE, CQM).
• Experience working in a startup environment.
• Experience working in a cleanroom environment.