Senior Quality Engineer

Location: 4 Gill Street, Unit B, Woburn, MA 01801Reports To: Lead Quality ManagerEmployment Type: Full-Time, In-OfficeCompensation: $115,000-$130,000Company DescriptionStemWave is a fast-growing medical device company based in Massachusetts, pioneering orthopedic shockwave technology in the U.S. Our technology is helping change the lives of practitioners and patients by advancing healing and expanding access to effective, non-invasive pain management solutions. Recognized among the fastest-growing privately held companies in 2023 and 2024, we are continuing to expand our team and capabilities to support rapid growth.We operate at the crossroads of medical device and technology, combining the rigor of a regulated healthcare environment with the speed, ownership, and innovation of a scaling tech company. People are at the center of our growth, and we are building a team of motivated, collaborative individuals who take pride in meaningful work and tangible results.We hold high standards and believe great performance thrives in an environment that is collaborative, energized, and genuinely enjoyable to be part of. This is a high-ownership culture where strong ideas are welcomed, teamwork matters, and each new hire plays a meaningful role in shaping the organization we are becoming.Position SummaryStemWave is seeking a Senior Quality Engineer to lead medical device quality and compliance across design, development, and into manufacturing and postmarket activities. This role will own the quality strategy for product development, working closely with Engineering to ensure robust design controls, risk management, and verification and validation processes are defined, executed, and continuously improved.This individual will take ownership of the Design and Development File (DDF), requirements traceability, and risk management framework, while driving high-quality documentation and regulatory alignment. Beyond execution, this role will shape and scale quality systems, influence cross-functional decisions, and help build the foundation for manufacturing and postmarket quality as the organization grows.What You’ll DoOwn quality strategy across product development and production, ensuring robust requirements traceability, verification planning, design transfer readiness, and DDF/MDF integrityLead risk management activities across the lifecycle, including Hazard Analysis and FMEAs (DFMEA/PFMEA), driving alignment to ISO 14971 and influencing design decisionsDrive design verification and validation (V&V), partnering with Engineering to define strategy, approve protocols, and ensure high-quality execution and documentationLead validation of processes and equipment (IQ/OQ/PQ), including protocol/report ownership and final approval of objective evidenceOwn and scale Greenlight Guru Ultralight eQMS, establishing best practices for traceability, risk management, document control, and change managementDrive QMS maturity by authoring and improving SOPs, leading internal audits, and preparing the organization for external auditsOwn supplier quality processes, including incoming inspection strategy, SCAR management, and supplier-related change controlLead production quality initiatives, including sampling strategies (ANSI/ASQ Z1.4), MSA/GR&R, process controls, and continuous improvement effortsOwn CAPA and Nonconformance systems, leading investigations, driving root cause analysis, and ensuring timely, effective closureWhat We’re Looking ForBachelor’s degree in engineering or related technical field4–8+ years of quality engineering experience in medical devices (Class II preferred)Strong knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, and ISO 14971Proven experience leading design quality efforts as the Quality representative on cross-functional product teamsDeep, hands-on experience with risk management, requirements traceability, and V&V strategy and executionDemonstrated ownership of QMS processes, CAPA systems, and audit readinessStrong experience with Greenlight Guru Ultralight or similar eQMS platformsAdvanced proficiency in statistical methods (sampling plans, MSA/GR&R, data analysis using Minitab/Excel)Strong cross-functional leadership skills with the ability to influence Engineering, Operations, and RegulatoryAbility to operate independently, prioritize across competing initiatives, and drive quality outcomes in a fast-paced environmentBenefitsUnlimited Paid Time Off14 Paid Company HolidaysComprehensive Health Coverage: Medical, dental, and vision insurance - 100% employer paidHSA Option: Add a Health Savings Account to a high-deductible health planPaid Parental LeaveEmployee Referral Program: Earn rewards for helping us grow our teamWhy Join UsLeadership: Help practices and medical centers adopt groundbreaking technology that empowers patients and allows practitioners to offer versatile treatment optionsExposure: Work closely with key decision-makers in the healthcare space, expanding your network and influence in a rapidly growing industryGrowth: Join an energetic and innovative culture where your ideas are valued. You’ll have the opportunity to contribute to company growth, take on new projects, and further your careerAt StemWave, we're not just building devices, we're building a movement. Join us and be a key contributor to our growth and success.