In this role you
The role handles the entire design control process, from validating design inputs to overseeing verification, validation, and design transfer.
Your role:
• Plans and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
• Leads the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards. Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence.
• Leads quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability. Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.
You're the right fit if:
- Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
- 5+ years of experience with Bachelor's in areas such as Medical Device, Design Quality Assurance, Risk Management, Quality Control, Quality Audit, or equivalent.
- We prefer 8+ years of experience with medical device regulations and standards, Design Quality Management, Design for Quality, Root Cause Analysis, CAPA Methodologies, Data Analysis.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
How we work together
We believe that we are better together than 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 Gainesville FL is $120,000 to $170,400 Annually.
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.
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.
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.
Additional Information
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 Gainesville FL.
#LI-PHI
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.
Skills Required
- Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent
- 5+ years of experience in medical devices, design quality assurance, risk management, quality control, quality audits, or equivalent
- Experience with medical device regulations and standards
- Experience with Design Quality Management
- Experience with Design for Quality
- Experience with root cause analysis
- Experience with CAPA methodologies
- Experience with data analysis
- US work authorization without current or future visa sponsorship
- Residence in or within commuting distance to Gainesville, Florida
Philips Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Philips and has not been reviewed or approved by Philips.
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Retirement Support — Retirement support is positioned as a standout, including a strong 401(k) match (often described at 7%) alongside pensions in some contexts.
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Flexible Benefits — Flexible benefits are emphasized through choice in health insurance options and a broad “Total Rewards” approach that combines compensation, health and wellness, and work-life support.
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Leave & Time Off Breadth — Leave and time off breadth appears strong, with generous paid time off and policies covering parental leave, caregiving responsibilities, volunteering, and family medical leave.
Philips Insights
What We Do
As a leading health technology company, it is our purpose to improve people’s health and well-being through meaningful innovation. Our goal is to improve 2.5 billion lives per year by 2030. We're always looking for ways to make life better – not only for our customers, but also for everyone working here. That's why we're taking steps to create an environment where we all 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.
