Software Design Quality Engineer

Lead in setting Quality and Reliability targets for IGT Systems medical software, ensuring these innovative products deliver high quality and outstanding reliability. Provide expert Quality and Reliability engineering support to project teams, assuring targets are achieved. This involves advising on quality and reliability engineering topics, validating design inputs, overseeing quality plan execution, and contributing to risk mitigation and design controls throughout the product lifecycle.

Must Have

• Ensure appropriate project and quality plans are made.
• Validate key design inputs including requirements, specifications, useability, reliability, performance.
• Provide effective oversight during Quality Plan execution and risk management activities.
• Contribute to identifying critical quality attributes (CTQ, CTS) and applying mitigations.
• Facilitate design failure mode and effect analysis (FMEA).
• Ensure design output meets design input with objective V&V evidences.
• Lead quality-related problem solving with cross-functional teams.
• Use post-market data for analytics and statistics to report on product performance.
• Act as a single point of contact for project teams on design quality requirements.
• Make substantial contribution to integrate reliability engineering activities.
• Oversee project deliverables and provide quality input, including safety, efficacy, regulatory.
• Participate in audits and regulatory inspections as design quality SME.
• Bachelor’s engineering degree with 12 years / Master’s degree with 10+ years of experience in Software Engineering, quality engineering, SW Quality- or Reliability Engineering role.
• Ability to define detailed software quality and reliability plans.
• Ability to contribute to Risk Management and lead FMEA activities.
• Strong exposure to application of Design Controls and thorough Design Reviews.
• Ability to partner with V&V teams for thorough Verification, Validation and Useability testing.
• Analyze development and field data for Product Safety, Quality and Reliability performances.
• Well conversant with statistical data analysis, regression modeling, reliability growth assessment.
• Experience with adequate and accurate review of DHF and DMR documents.
• Understanding of global medical device regulations, requirements, and standards (21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304, ISO 14971).
• Experience with working in multidisciplinary teams in a high-tech R&D environment.
• Effective interpersonal, written and oral communication skills.
• Ability and willingness to work onsite.

Good to Have

• Software testing experience

Perks & Benefits

• Hybrid work concept fusing flexibility with collaboration
• Workspaces designed to support well-being and career advancement
• Equal opportunities and commitment to inclusion and diversity
• Opportunity to create a healthier society through innovative health technology solutions

In this role, you have the opportunity to

Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved.

This involves being a confident advisor on quality and reliability engineering topics.

You are responsible for

• Ensure that appropriate project plan and quality plans are made that include all stages of the product’s lifecycle, targets and strategy for a robust software products development.
• Validates key design inputs including requirements, specifications, useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs.
• Provides effective oversight during the execution of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle.
• Contribute during design and development to identify critical quality attributes (CTQ, CTS) and ensure that appropriate mitigations and design controls are applied to mitigate the risks.
• Facilitate design failure mode and effect analysis to identify failure modes early in the design and development process and apply design, manufacturing and inspections to mitigate the risks.
• Ensure with objective V&V evidences that design output meets the design input.
• Leading quality related problem solving with the cross functional teams
• Using post-market data for analytics and statistics to report on the product’s performance in the market (provide feedback to manufacturing, suppliers, or design teams) and initiate field actions when required.
• Act as a single point of contact (person assigned to) for project team(s); you’re responsible to ensure the product’s design quality related requirements/criteria are complete and meet the quality standards for every project milestone.
• Make substantial contribution to integrate reliability engineering activities with the medical device development activities.
• Effective oversight of project deliverables and provide quality input, including safety, efficacy, regulatory. Facilitate the product defect investigations and actions during defect management review meetings.
• Participate in audits and regulatory inspection as design quality SME and guide other cross-functional stakeholders on technical aspects and audit conduct.

You are a part of

You will be part of the global Philips Q&R organization and will be reporting within the Design Quality team for IGT-Systems. As member of this team, you contribute to our constant strive for further product quality improvements, so we continuously exceed both internal and external stakeholder expectations.

To succeed in this role, you should have the following skills and experience

We are looking for a self-motivated and skilled individual who continuously strives for excellence as a way of life, not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people, that Philips improves every year.

Specific skill requirements for this role include:

• Bachelor’s engineering degree with 12 years / Master’s degree with 10+ years of experience; in Software Engineering, quality engineering, SW Quality- or Reliability Engineering role in the medical or aerospace industry.
• Software testing experience will be an added advantage
• Ability to define detailed software quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable.
• Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate (critical) requirements.
• Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality.
• Ability to partner with V&V teams to assure thorough Verification, Validation and Useability testing.
• Analyze development and field data for Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.
• Well conversant with statistical data analysis, regression modeling, reliability growth assessment and other quality techniques
• Experience with adequate and accurate review of DHF and DMR documents.
• Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971.
• Experience with working in multidisciplinary teams in a high-tech R&D environment.
• Effective interpersonal, written and oral communication skills expected.
• Ability and willingness to work onsite

How we work at Philips

Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart

Our commitment to inclusion and diversity

At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our company , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law. For, we believe that life is better when #youareyou.

Our hybrid working model is defined in 3 ways:

We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.

We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.

We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

About Us

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.