Senior Product Quality Assurance Engineer (Hybrid)

The primary role of a Senior Design Quality Engineer ensures new and sustaining products meet quality and safety standards, regulatory requirements, and user needs to support the design and development of digital health products. They specialize in design controls ensuring verification/validation (V&V) activities meet internal quality management system policies and procedures as well as external regulations and standards. They are responsible for internal and external auditing ensuring compliance to internal and external regulations/standards. They provide strategic business technical support around QA systems and processes to the organization. They have the capability to improve processes and procedures for compliance and continuous improvements. They have the ability to have strong emotional intelligence capability with expert negotiation skills.

Let’s Talk About Responsibilities

• Performs work in a specialized area of expertise that requires knowledge of principles and concepts for digital health applications.
• Responsibilities include:
• Contributing to and managing digital health projects with the ability to provide clear/concise executive summaries on overall health of projects
• Providing advice/direction in quality related topics as it relates to design and development of digital health products.
• Leveraging professional expertise and relationships to contribute to strategy and drive business results
• Networking and building strong relationships with contacts outside own area of expertise
• Ability to work independently, with guidance in only the most complex situations
• Frequently leads sub-functional teams or projects and train and mentor junior team members
• Serves as a best practice resource within own area of work
  
  
  

Let’s Talk About Qualifications And Experience

Required:

• Bachelor’s degree in engineering with minimum of 5 years of experience OR a Master's degree in engineering with minimum of 3 years of experience.
• Advanced knowledge of FDA design controls for new product development with sound knowledge on phase gate design approach.
• Experience with digital health software applications required with working knowledge of IEC62304 and IEC82304.
• Basic to intermediate understanding of Artificial Intelligence tools such as VS Code, GitHub Copilot and ChatGPT required.
• Experience with conducting internal and external audits required. Prior experience as a key backroom audit member required (i.e. scribe, document reviewer).
• Experience leading/supporting CAPAs, NCRs and Issue Impact Assessments.
• Experience with risk management tools with clear demonstration of using risk management within the design phase lifecycle.
  
  
  

Preferred:

• Advanced knowledge of AI Tools with prior working knowledge of building AI agents.
• Previous experience creating dashboards using JIRA and Confluence.
• Knowledge of statistical analysis with relation to sample sizes.
  
  
  

We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance. Employees accrue fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.

Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills.

At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current base range for this position is: $122,000 - $184,000

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!