Senior Quality Engineer

SharkNinja•Needham, MA

19d•Onsite

About The Position

SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja , the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world. AI at SharkNinja At SharkNinja, we’re building an AI-native culture. We’re not waiting for the future; we’re creating it. Our people are expected to experiment boldly, adopt new tools, and continuously raise what’s possible to create meaningful impact for our consumers. If you believe the best way to do your job hasn’t been invented yet, you’ll fit right in. We are seeking a strategic, analytical, and collaborative Senior Quality Engineer to join our Product Quality Team. This high-impact role, you will champion consumer safety, device efficacy, and regulatory-aligned quality throughout the product lifecycle — ensuring that every product delivers a trustworthy, high-performance skincare experience. You will collaborate cross-functionally with R&D, Human Factors, Clinical/Scientific Affairs, Industrial Design, Supply Chain, Manufacturing, Customer Experience, Marketing, and Executive Leadership to shape skincare devices that not only meet specifications but consistently exceed user expectations — pre- and post-launch. This is an exceptional opportunity to influence device design, quality strategy, and consumer satisfaction at scale, while gaining exposure to executive-level decision-making and innovation initiatives across the company.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Quality Engineering, Product Development, Human Factors Engineering, or a related technical discipline.
4–7 years of experience in quality engineering with a strong focus on new product development
Experience working with risk management, verification/validation, and design controls in a regulated or semi-regulated device environment.
Deep understanding of medical-device-relevant product development lifecycle, risk management, design control, and verification/validation requirements.
Proficient with root cause analysis tools (5 Whys, Fishbone, Fault Tree), FMEA, and statistical analysis.
Strong knowledge of change management, CAPA processes, manufacturing quality, engineering documentation, and control methodologies.
Strong problem-solving mindset, attention to detail, and structured analytical approach.
Excellent written and verbal communication skills with the ability to influence technical and non-technical stakeholders and present to leadership.
High degree of autonomy, initiative, accountability, and follow-through in driving cross-functional programs to completion.

Nice To Haves

Working knowledge of standards such as ISO 9001, ISO 13485, IEC/UL device safety standards, ISO 14971 (Risk Management), and human factors guidelines is highly preferred.
Proficient in Microsoft Office Suite; experience with PLM platforms, quality systems, and eQMS tools is a plus.

Responsibilities

Customer-Centric Quality Leadership: Analyze consumer complaints, device returns, skin-interaction feedback, clinical testing outcomes, and post-market surveillance data to identify root causes and drive both technical and user-experience corrective actions.
Act as the voice of the consumer and patient in product quality forums, ensuring clinical insights, feedback, and user safety concerns lead to meaningful device improvements.
Lead structured problem-solving.
Product Development Support: Serve as the NPD Quality lead for device programs, providing input into design controls, safety assessments, human factors reviews, and documentation from early concept through verification, validation, and launch.
Provide quality input on Engineering Change Notices (ECNs), ensuring robust verification/validation and safeguarding device performance, safety, and claim integrity.
Partner with R&D, Clinical/Scientific Affairs, and Product Development to define, measure, and validate critical-to-quality (CTQ) attributes such as skin compatibility, thermal/electrical safety, treatment efficacy, and reliability.
Ensure biocompatibility considerations, labeling requirements, and claims substantiation are integrated into the product development lifecycle.
Process & Supplier Quality Integration: Collaborate with suppliers on root cause investigations and ensure timely and compliant closure of corrective and preventive actions (CAPAs) — especially for contact materials, energy-based components, and precision hardware elements.
Influence manufacturing readiness by identifying device-specific failure modes (e.g., thermal drift, optical degradation, vibration consistency, firmware/hardware interaction issues) and recommending risk-reducing controls.
Support production transfer activities by ensuring alignment between design intent, process capability, and device quality requirements.
Post-Launch & Lifecycle Quality Management: Monitor macro-level product performance trends, consumer sentiment, and post-market surveillance indicators to identify early warning signals for skincare-specific risks (e.g., irritation reports, thermal anomalies, inconsistent treatment outcomes).
Drive iterative improvements to both hardware and user-experience elements post-launch, collaborating with Engineering, Design, and Quality partners.
Own product health dashboards and deliver actionable insights to senior leadership — emphasizing device safety, reliability, and real-world efficacy.
Cross-Functional Influence & Continuous Improvement: Facilitate cross-functional quality meetings, delegate issue resolution, and ensure clear ownership and accountability across engineering, supply chain, and other teams.
Identify and implement process efficiencies within design control workflows, documentation management, risk files, and testing strategies.
Coach junior engineers or quality team members to elevate the rigor, technical depth, and compliance mindset of the overall Quality function.