SharkNinja · 21 hours ago
Senior New Product Development Quality Engineer- Skin
Needham, MA
Full-time
Onsite
Mid, Senior Level
$108K/yr - $163K/yr
4+ years expSharkNinja is a global product design and technology company known for its innovative lifestyle solutions. They are seeking a Senior Quality Engineer to lead quality initiatives in the development of skincare and beauty-tech medical devices, ensuring consumer safety and regulatory compliance throughout the product lifecycle.
BeautyConsumer ElectronicsConsumer GoodsRetail
Responsibilities
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, dermatological feedback, and user safety concerns lead to meaningful device improvements
Lead structured problem-solving (8D, DMAIC) and medical-device-appropriate risk assessment activities (e.g., Design FMEA, Use-Related Risk Analysis)
Serve as the NPD Quality lead for skincare 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, skin 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
Collaborate with suppliers on root cause investigations and ensure timely and compliant closure of corrective and preventive actions (CAPAs) — especially for skin-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 skincare-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 (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, Clinical, and Quality partners
Own product health dashboards and deliver actionable insights to senior leadership — emphasizing device safety, reliability, and real-world efficacy
Facilitate cross-functional quality meetings, delegate issue resolution, and ensure clear ownership and accountability across engineering, supply chain, and clinical 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
Qualification
Required
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 for skincare/beauty devices, medical devices, wellness technology, or consumer electronics with biological interaction
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
Preferred
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
Familiarity with dermatology considerations (e.g., biocompatibility, irritation testing, claims support) is a plus
Experience with PLM platforms, quality systems, and eQMS tools is a plus
Benefits
Medical insurance
Dental insurance
Vision insurance
Flexible spending accounts
Health savings accounts (HSA) with company contribution
401(k) retirement plan with matching
Employee stock purchase program
Life insurance
AD&D
Short-term disability insurance
Long-term disability insurance
Generous paid time off
Company holidays
Parental leave
Identity theft protection
Pet insurance
Pre-paid legal insurance
Back-up child and eldercare days
Product discounts
Referral bonus program
Wellness programs
Company
SharkNinja
SharkNinja is a consumer goods company that offers beauty, home care, kitchen appliances, and outdoor electronic products.
1001-5000 employees
H1B Sponsorship
SharkNinja has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (40)
2024 (33)
2023 (18)
2022 (22)
2021 (29)
2020 (24)
Funding
Current Stage
Public CompanyTotal Funding
$1.2BKey Investors
CDH Investments
2025-08-20Post Ipo Secondary· $638M
2024-03-19Post Ipo Secondary· $272.13M
2023-12-04Post Ipo Secondary· $286.47M
Leadership Team
Mark Barrocas
Chief Executive Officer
Adam Quigley
EVP, Chief Financial Officer
Recent News
2025-12-17
Investor's Business Daily
2025-12-16
Company data provided by crunchbase