Senior Manager - Design Quality (Digital Product)

Job Summary

Global Product Quality/QA supports and collaborates with the Engineering group and Cross Functional teams to enable a diverse range of product releases in an efficient and compliant way.

This role will provide supportive and inspirational leadership of the Product Quality team supporting Digital Product Development, while also having a direct “hands-on” contribution.

Within Digital Product Development, the products supported will be standalone software, this includes SaMD and health software, e.g cloud based software systems, mobile phone apps.  For potential candidates, please only apply if you have direct experience working with these product types.

Job Summary

Let’s talk about Responsibilities:

• People management and leadership of direct reports.  Develop team culture and support development and growth opportunities for the team, with regular feedback to ensure team members continue to develop and grow their capability and be the best that they can.

• Work with the team and stakeholders to ensure the required support is provided across different project types.  This will require collaboration and flexibility to support the following:

  • Enabling new strategies, platform products, Incubation and Growth areas, from concept to commercial launch.  This requires understanding emerging technologies in relevant areas, e.g. in consumer products, Digital Health, artificial intelligence, machine learning.

  • Providing expertise to improve design control processes, systems and tools.

  • Focus on delivery excellence and consistency, to ensure product releases are compliant and meet business timelines, e.g. in execution of QA plans, review and approval of deliverables, escalation of risks.

• Be reactive to analyses potential quality risks.  Identify and support or lead resolution of quality risks that impact product development, with effective escalation, collaboration and communication.

• Support the capability of QA, Engineering and cross-functional representatives by awareness of current and changing industry requirements/guidance/best practice in the area of product development.  Disseminate information and provide appropriate informal and formal training.

• Partner across functions and leadership to champion product quality and drive quality considerations into key decisions.

• Proactively source inputs from the business (e.g.QA, cross-functional teams, leadership) to inform strategy and identify improvement areas, and then lead implementation of associated changes.

• Manage delegation and assignment of workload within the team and participate in resource planning for current and future projects.

• For assigned product/s, achieve the above both at an overall level as well as through hands on individual contribution as primary QA representative.

• Subject Matter Expert on Design Controls in audits, contribute to resolving relevant CAPAs and maintaining the QMS.

• Ensure implementation and compliance to ResMed health and safety management systems within the areas of responsibility, and monitor the health and safety performance of direct reports.

Let’s talk about Qualifications and Experience

• Degree in Engineering, Computer Science, Science or other tertiary qualifications deemed appropriate for this position.

• Significant experience in relevant roles, e.g. 8+ years of experience in design quality including software products.

• Demonstrated experience in people leadership and stakeholder engagement.

• Demonstrated ability to take initiative and work with minimal supervision to achieve role responsibilities effectively.

• Expert knowledge in global requirements for design controls and quality systems for medical device development and their application on released products, e.g ISO13485, 21 CFR Part 820, EU MDR, ISO14971.

• Direct experience with IEC62304, IEC82304 and different software development methodologies, e.g. Agile, DevOps.

• Demonstrated ability to accomplish goals and embrace change while working with Product Development stakeholders is required:

  • Strong knowledge of current good design practices for hardware/software, applicable design control elements that can be applied in medical and non-medical projects.

  • Real-world experience in leading critical projects in areas of product development, design controls, verification & validation, risk management and change control for individual and System projects

  • Experience coordinating issue resolution using a risk-based approach.

• Strong analytical and problem-solving skills, with a focus on continuous improvement.

• Excellent written, verbal communication and collaboration skills with a strong ability to negotiate and influence

Qualifications

• Project management experience/qualification

• Experience with Class I and Class II medical devices, EU MDR, MDDS (Medical Device Database Systems), CDS (Clinical Decision Support) devices.

• Recent strong experience working on System/ Platform and Software medical projects preferred.   

• Experience handling medical and non-medical projects.

• Risk Management experience (Hazard analysis, FMEA, Safety risk assessments)

• Third party Audit experience (MDSAP, ISO recertification, FDA QSR audits etc)

• Experience implementing new standards/ regulations/ best practices in QMS/ Software development and training cross-functional team members.

• Basic understanding of Statistical data analysis for testing.

• Applied experience with quality and statistical analysis tools (SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis).

• Quality Certification preferred (e.g., ASQ CQE, Six Sigma etc.)

• Familiarity with EU GDPR, AI laws, other US and International AI regulations/ standards/ guidance's would also be considered an asset.

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.

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

Subject to the absolute discretion of the company, this role may be eligible for an annual cash bonus payment based on company, business unit, and/or individual performance.

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 range for this position is:

Total Base Pay Range

$149,000.00 - $224,000.00 USD Annual USD Annual

For remote positions located outside of the US, pay will be determined based the candidate’s geographic work location, relevant qualifications, work experience, and skills. 

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!