We are changing the standard of care for millions of untreated sufferers of ENT conditions. We improve patient access to life-changing relief through safe, practical, and effective innovation that changes how and where patients are served. Aerin differentiates itself with our commitment to providing straightforward and clinically proven products so that ENTs and their patients can make treatment decisions together without limits.
At Aerin Medical our values show up as: always seeking the collective good, holding ourselves and each other accountable, showing respect with compassion, creation and innovation and being all in.
As the Senior Design Assurance Engineer, you will be an essential part of our mission-driven team, dedicated to transforming the lives of those with untreated ENT conditions. Your role will involve contributing directly to our commitment to innovation and improved patient care.
PURPOSE OF THE JOB:
This position is responsible for ensuring the quality, safety, and regulatory compliance of Aerin’s medical device designs throughout the entire product development lifecycle. The role involves close collaboration with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure that design & development processes comply with to regulatory requirements, applicable standards, industry guidelines, and Aerin’s policies.
MAJOR DUTIES AND RESPONSIBILITIES:
Product Design
- Work cross-functionally with R&D, Project Lead, Manufacturing/Operations, Regulatory Affairs, Clinical and Marketing to provide design assurance expertise (e.g., on design control and risk management principles) and ensure alignment with product development timelines and milestones.
- Participate in new/modified product development projects and support completion of deliverables required for each design phase. This includes defining product design requirements, specifications, overseeing design verification and validation activities, manufacturing process/sterilization validation.
- Evaluate impact to design controls and risk assessment for product related changes initiated by R&D and/or contract manufacturer and assist in the creation of required documentation or justifications to validate the proposed change.
- Support product development teams to ensure V&V activities sufficiently meet the device input requirements. Support and lead technical investigations and root cause analysis for any design or process-related issues raised during development, testing, or post-market surveillance, such as test failures, deviations, non-conformity, complaint, CAPA and Supplier CAPA.
- Lead the risk management process in accordance with ISO 14971 to identify, assess, and mitigate potential risks throughout the design and development process.
- Facilitate risk management activities through Failure Modes and Effects Analysis (FMEA) and hazard analysis, to ensure that risk control measures are properly implemented and effective.
- Provide guidance and support in the design development and coordination of Design Verification and Validation activities to demonstrate the product meets intended use, performance, and safety requirements.
- Demonstrate knowledge and application statistical techniques to comply with associated regulatory requirements and internal standards.
- Act as an independent reviewer for design and phase reviews, ensuring objectivity and thorough evaluation of key elements.
- Work with Regulatory Affair team to ensure compliance with FDA, CE mark, and other regulatory bodies' requirements during the design phase and support product submissions.
- Facilitate and assist in the execution of supplier qualification activities.
- Other
- Support supplier audits and external regulatory body audits.
- Analyze and track product quality data/metrics in support of Quality Objective and Management Review
- Support and provide inputs to other non-product related issues such as non-conformity, complaint, and CAPA
- Support quality system implementation projects
- Provide process improvements to QMS as appropriate Any other tasks as assigned
EDUCATION REQUIREMENTS:
- Bachelor’s degree or diploma in Science, Engineering, Quality or similar discipline is highly recommended
EXPERIENCE REQUIREMENTS:
- 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
OTHER QUALIFICATIONS:
- Independent, high level of initiative and ownership to drive department and organization goals
- Good problem-solving skills
- Proactive and ability to work well with cross-functional departments and stakeholders in a constructive manner
- Excellent interpersonal and communication skills (both verbal and written) that allow for effective communication within all levels of organization
BENEFITS AND PERKS:
Our culture is rooted in our core values every day, in everything we do.
Our benefits focus on the 5 dimensions of wellbeing: physical, financial, emotional, career and community. 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.