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- Tasks: Lead software design assurance for innovative medical devices, ensuring safety and compliance.
- Company: Philips is a global health technology leader dedicated to improving lives through innovation.
- Benefits: Enjoy generous PTO, 401k matching, education reimbursement, and more perks.
- Why this job: Join a mission-driven team that values every human and fosters continuous improvement.
- Qualifications: 8+ years in FDA regulated environments; leadership experience and a relevant degree required.
- Other info: This role requires onsite presence at least 3 days a week.
The predicted salary is between 80000 - 120000 £ per year.
Sr. Manager- Software Design Assurance page is loaded
Sr. Manager- Software Design Assurance
Apply locations Plymouth Colorado Springs San Diego time type Full time posted on Posted 16 Days Ago job requisition id 556378
Job Title
Sr. Manager- Software Design Assurance
Job Description
The Sr. Manager-Software Design Assurance will play a critical role in managing/supporting the Software Design Control process for new/existing Image Guide Therapy Devices (IGTD), ensuring they are safe, reliable, and compliant with all software design standards, processes, and requirements.
Your role:
- Responsible for functional/operational team leadership including budgeting, training, performance management, technical/professional development and mentorship to engineers and quality teams, helping them meet schedules, resolve technical challenges, and manage performance requirements, while fostering a culture of continuous improvement and quality excellence.
- Provides Software Quality leadership for NPI and sustaining product development teams for stand-alone software projects (SaMD) as well as software-related aspects of complex medical systems (SiMD). Manages the development, oversight and execution of comprehensive software quality plans and associated risk management activities throughout the software lifecycle.
- Will Drive in-depth root cause analysis of software quality issues, guiding teams in advanced problem-solving techniques to resolve deficiencies, improve software design processes, and ensure that quality is integral to all development stages. Drives process improvement initiatives, adopting best practices, cutting-edge tools, and innovative methodologies to continuously enhance software quality and regulatory compliance.
- Will oversee the development, maintenance, and management of comprehensive software quality documentation, including Software Requirement Specifications (SRS), ensuring they are accurate, up-to-date, and fully compliant with relevant standards, regulatory requirements, and internal policies throughout the software lifecycle.
- Authorizes/Leads the assessment, validation and approvals of software designs/inputs, overseeing the review of test/performance data to ensure compliance with quality, safety, and regulatory standards, while identifying and addressing engineering deficiencies to embed quality within the designs.
- Leads the creation/review of risk management files-plans, product hazard analysis, FMEAs, Risk Management Matrix, Benefit Risk Determination and Ensures Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc.
You\’re the right fit if:
- You have a minimum of 8+ years’ experience in FDA regulated, IEC 62304 medical device software environments (SiMD/SaMD), with a focus on Software Design Assurance/Control , detailed knowledge of Risk Management (ISO 14971/ AAMI TIR45) and strong Understanding of all aspects of the QMS related to Design Controls.
- You’ve acquired a minimum of 3+ years’ experience in functional team leadership, including departmental budget, mentoring, training, performance management and technical/professional development of Design Assurance team members.
- You have the proven ability to cultivate and maintain strong relationships with internal and external stakeholders, at all levels, by sharing knowledge, providing insights, and ensuring alignment with software quality standards, regulatory requirements, and project objectives.
- You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Reliability (DfR), Agile, and SAFe.
- You have a minimum of a Bachelor’s Degree in Computer Science/Applications, Quality, Engineering or a related Scientific discipline (required). ASQ, Agile or other applicable certifications (desired).
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
How we work together:
We believe that we are better together than we are apart. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.
About Philips:
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 improve the lives of others.
- Learn more about our business .
- Discover our rich and exciting history.
- Learn more about our purpose.
- Learn more about our culture.
Philips Transparency Details:
- The pay range for this position in Plymouth, MN is $120,488 to $192,780.
- The pay range for this position in San Diego, CA is $128,520 to $205.632.
- The pay range for this position in Colorado Springs, CO is $114,750 to $183,600.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here .
Additional Information
- This role may require travel up to 10%.
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
- Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN, Colorado Springs, CO or San Diego, CA.
#LI-PH1
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
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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.
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Sr. Manager- Software Design Assurance employer: Philips International
Contact Detail:
Philips International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr. Manager- Software Design Assurance
✨Tip Number 1
Familiarise yourself with the latest FDA regulations and IEC 62304 standards. Being well-versed in these guidelines will not only help you understand the role better but also demonstrate your commitment to compliance during discussions.
✨Tip Number 2
Network with professionals in the medical device industry, especially those involved in software design assurance. Attend relevant conferences or webinars to build connections and gain insights that could be beneficial during interviews.
✨Tip Number 3
Prepare to discuss specific examples of how you've led teams through complex software quality challenges. Highlighting your leadership experience and problem-solving skills will resonate well with the hiring team.
✨Tip Number 4
Research StudySmarter's culture and values, as well as Philips' mission in health technology. Tailoring your conversations to align with our goals will show that you're not just a fit for the role, but also for our team.
We think you need these skills to ace Sr. Manager- Software Design Assurance
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in FDA regulated environments and software design assurance. Use specific examples that demonstrate your leadership skills and technical expertise relevant to the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for health technology and how your background aligns with the company's mission. Mention your experience in managing software quality plans and risk management, as these are key aspects of the job.
Highlight Relevant Experience: Clearly outline your 8+ years of experience in software design assurance and your understanding of QMS related to design controls. Use bullet points to make this information easy to read and impactful.
Showcase Leadership Skills: Emphasise your functional team leadership experience, including mentoring and performance management. Provide examples of how you've fostered a culture of continuous improvement and quality excellence in previous roles.
How to prepare for a job interview at Philips International
✨Showcase Your Leadership Experience
As a Sr. Manager, you'll need to demonstrate your leadership skills. Prepare examples of how you've successfully led teams, managed budgets, and mentored engineers in previous roles. Highlight specific challenges you faced and how you overcame them.
✨Understand Software Design Assurance
Make sure you have a solid grasp of software design assurance principles, especially in FDA regulated environments. Be ready to discuss your experience with risk management standards like ISO 14971 and AAMI TIR45, as well as your familiarity with quality management systems.
✨Prepare for Technical Questions
Expect technical questions related to software quality and design processes. Brush up on your knowledge of software lifecycle management, root cause analysis, and problem-solving techniques. Being able to articulate your thought process will impress the interviewers.
✨Demonstrate Continuous Improvement Mindset
Philips values a culture of continuous improvement. Be prepared to discuss how you've implemented process improvements in past roles. Share specific examples of best practices or innovative methodologies you've adopted to enhance software quality and compliance.
