Senior Design Assurance Engineer

January 10

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Aryma Labs

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Aryma Labs is a global company specializing in marketing efficiency and effectiveness in a privacy-first era. They leverage advanced data science solutions, including Marketing Mix Modeling (MMM), causal inference, and experimentation, to help enterprises optimize their marketing performance and return on investment (ROI). Aryma Labs offers a comprehensive suite of products such as ArymaEdge, MMMGPT, and MMMDiagnose, designed to provide insights into marketing attribution and efficiency across various channels. Their services are tailored to enterprises of all sizes, aiming to reduce costs and improve marketing strategies' outcomes. With a focus on privacy-compliant marketing measurement, Aryma Labs helps clients worldwide navigate marketing measurement gaps, providing robust models and insights for enhanced decision-making.

Natural language processing • Artificial Intelligence • Data Visualization • Digital Analytics • Data Science

2 - 10 employees

🤝 B2B

🏢 Enterprise

☁️ SaaS

📋 Description

• Aerin Medical is changing the standard of care for millions of untreated sufferers of ENT conditions. • The Senior Design Assurance Engineer ensures quality, safety, and regulatory compliance of medical device designs. • The role involves collaboration with R&D, Manufacturing, and Regulatory Affairs for compliance. • Responsibilities include providing design assurance expertise, leading risk management processes, and facilitating audits.

🎯 Requirements

• Bachelor’s degree or diploma in Science, Engineering, Quality or similar discipline is highly recommended. • At least 5 or more years of experience in Quality Assurance and or Design Assurance, Sustaining, R&D and/or manufacturing function in medical device industry is required. • Strong understanding of Design Controls and Risk Analysis and applicable standards and regulations (e.g., ISO 13485, ISO 14971, EU Medical Device Directive / EU Medical Device Regulations and FDA QSR Part 820). • Hands-on experience with Failure Modes and Effects Analysis (FMEA) and risk assessments is required. • Prior experience in medical device manufacturing, product validation, gamma/EO sterilization and/or statistical analysis. • Prior experience with US FDA Class II medical device design and development supporting electromechanical medical devices, sterile disposables and software validation requirements. • Hands-on experience with Design V&V test plan development and report review and approval.

🏖️ Benefits

• Physical benefits include Medical – PPO & HSA with co-contribution, Dental, Vision, Accident Insurance, Critical Illness, Hospital Indemnity, and onsite Tonal & Peloton. • Financial benefits include HSA/FSA, 401k with company match, Lifestyle Spending Account, Long Term Disability, Life Insurance, a monthly stipend to cover phone and tech costs, employee discounts, and weekly office lunches. • Emotional benefits include Employee Assistance Program, 5 free counseling sessions per issue per year, 80 hours sick leave, 13 holidays, and flexible vacation (exempt employees). • Career and Learning & Development opportunities with Aerin led leadership trainings. • Community initiatives which include Aerin “give back” week, family days as well as Aerin holiday giving.