Sr. Manager- Software Design Assurance

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.

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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.