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Your role:
(4 x bullets max)
1. Experience- Minimum of 7 years relevant working experience in medical device to regulatory strategy development supporting submissions and product market introductions (required)
2. Skills- Regulatory affairs, 510K, De Novo, PMA, and registrations of medical devices globally (including India) is highly preferred, dossier Preparation
3. Education- Bachelors/Master of Science degree
4. Anything else-
Project planning and management skills (preferred)
Excellent verbal, written communication skills (English) & interpersonal skills.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .
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Duties and Responsibilities:
Responsible for the design, implementation, integration, and testing of enterprise backend components or modules in high quality, according to requirements, and on time.
Comply and align with software development professionalism standards within the team (processes and methodologies, quality of requirements, design, coding, and testing).
As a Software architect, you will leverage cloud technologies, particularly AWS, to architect, develop, and deploy scalable and resilient software modules and systems within complex and advanced environments.
Carries out complicated development and prototyping tasks.
Ability to work as a team player on multiple projects, including both new product life cycle development as well as maintenance of an already released product.
Promote domain knowledge, innovative thinking, and customer understanding.
Promote trust, and openness and leverage external capabilities locally and globally
Work closely with the System Architect / Product Architect to identify & answer important product/solution questions through prototypes or solutions
Drive technical excellence and quality improvements across the team
Ensure compliance to the Quality Management System and regulatory requirements
Education, Skills, and Experience Requirements:
9+ years of experience in SW Development
Hands-on experience in at least one modern language such as C++ or C#
Demonstrable experience with cloud technologies, specifically AWS
Ability to optimize cloud resources for performance and cost efficiency
Familiarity with DevOps practices and tools like terraform in a cloud environment.
Bachelor’s degree in software engineering/computer science /other relevant
Experience in backend development i.e. architecture design patterns, infrastructure, networking, availability, reliability, etc.
System aspectbackground/experiencein developing enterprise solutions
Excellent verbal and written communication skills with English fluency
Experience in international organization/ medical devices background – advantage
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What can you expect:
Based in North Ryde, with free onsite parking or close to transport.
Flexible and hybrid working environment.
Full time role, working with a great and supportive team.
Attractive salary package, benefit and even staff discount on Philips products
Long term career growth opportunities and development
You're the right fit if:
First of all, you pride yourself on your customer service skills and approach your work with a sense of urgency with each interaction where you are able to coordinate and negotiate for best customer experience and outcomes.
You will have previously held a focused customer service, coordinator position which has been fast paced such like high volume call centre, loan equipment or previous services scheduler experience would be great.
Excellent organisation and time management, have a sense of urgency and able to prioritize and reprioritize throughout your day.
Great Stakeholder engagement skills, you build strong relationships with different teams and customers to enhance collaboration and outcomes.
You will hold at minimum High School Certificate, Diploma, Vocational Education as a minimum and or Bachelor's Degree in Business Operations, Supply Chain Management, Operations or equivalent
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Job Description
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 relatedrequirements/criteriaare 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.
To succeed in this role, you should have the following skills and experience
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, regressionmodeling,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
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Our hybrid working model is defined in 3 ways:
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Information Security Lead
As a Senior Information Security Manager, you will be responsible for developing, implementing and monitoring a strategic, comprehensive IT security program while ensuring compliance with regulatory requirements, and mitigating risks to the organization's information assets. Information Security Manager will provide the vision and leadership necessary to manage the risk to the platform assigned and will ensure business alignment, effective governance, system and infrastructure availability, integrity and confidentiality.
You're the right fit if:
This role is an office role.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .
These jobs might be a good fit

Share
Your Role:
Your Role:
Onsite roles require full-time presence in the company’s facilities.
This role is an office-based role.
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Supply Planning Product Owner
You will lead implementing best-in-class supply planning capabilities across end-to-end supply chain to deliver superior customer service levels with optimized profitability. You will work with a team of dedicated professionals and collaborate cross-functionally to set standards of supply planning excellence, transform supply planning processes, and accelerate successful implementation of planning technology solutions that enhance our supply planning capabilities.
Accountabilities:
You're the right fit if you have:
Master’s or bachelor’s degree with at least 8+ years of overall work experience.
Domain Expertise
Shaping the Future
Leadership
How we work together
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .
These jobs might be a good fit

Share
Your role:
(4 x bullets max)
1. Experience- Minimum of 7 years relevant working experience in medical device to regulatory strategy development supporting submissions and product market introductions (required)
2. Skills- Regulatory affairs, 510K, De Novo, PMA, and registrations of medical devices globally (including India) is highly preferred, dossier Preparation
3. Education- Bachelors/Master of Science degree
4. Anything else-
Project planning and management skills (preferred)
Excellent verbal, written communication skills (English) & interpersonal skills.
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .
These jobs might be a good fit