Senior Quality Engineer

SharkNinja•Needham, MA

10d•$83,500 - $149,500•Onsite

About The Position

SharkNinja is a global product design and technology company seeking a strategic, analytical, and collaborative Senior Quality Engineer to join their Product Quality Team. This role champions consumer safety, device efficacy, and regulatory-aligned quality throughout the product lifecycle, ensuring trustworthy, high-performance skincare experiences. The engineer 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 meet and exceed user expectations. This position offers an opportunity to influence device design, quality strategy, and consumer satisfaction, with exposure to executive-level decision-making and innovation initiatives.

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.
Experience with PLM platforms, quality systems, and eQMS tools is a plus.

Responsibilities

Analyze consumer complaints, device returns, skin-interaction feedback, clinical testing outcomes, and post-market surveillance data to identify root causes and drive corrective actions.
Act as the voice of the consumer and patient in product quality forums, ensuring clinical insights and user safety concerns lead to device improvements.
Lead structured problem-solving.
Serve as the NPD Quality lead for device programs, providing input into design controls, safety assessments, human factors reviews, and documentation from concept through 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.
Ensure biocompatibility considerations, labeling requirements, and claims substantiation are integrated into the product development lifecycle.
Collaborate with suppliers on root cause investigations and ensure timely and compliant closure of corrective and preventive actions (CAPAs).
Influence manufacturing readiness by identifying device-specific failure modes and recommending risk-reducing controls.
Support production transfer activities by ensuring alignment between design intent, process capability, and device quality requirements.
Monitor macro-level product performance trends, consumer sentiment, and post-market surveillance indicators to identify early warning signals for skincare-specific risks.
Drive iterative improvements to both hardware and user-experience elements post-launch.
Own product health dashboards and deliver actionable insights to senior leadership.
Facilitate cross-functional quality meetings, delegate issue resolution, and ensure clear ownership and accountability.
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 Quality function.