Job Title
Electro-Mechanical Medical Device Design Quality Engineer
Job Description
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
In this role you have the opportunity to
The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes
Your role:
• Independently produces quality engineering documents, coordinates quality plan design for hardware/software and system design, and supports stakeholders during the execution of quality system, product audits, and inspections.
• Executes assessment of product and system designs, reviews of test and other performance data, analysis of market feedback, carrying root cause analysis, quality problem solving, and addressing quality engineering deficiencies to embed quality in design.
• Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
• Provides effective oversight of execution of quality, reliability, PMS Plans, Risk Management activities, and all design related activities during the product/system lifecycle including deliverables created by other functions/organizations to assure product and process compliance.
• Maintains a working knowledge of generic products/services and Quality Engineering techniques, addresses problems of diverse scope, requiring the evaluation of identifiable factors, demonstrating sound judgment in selecting methods for obtaining solutions, and frequently interacts with supervisors and functional peer groups to gain cooperation of others.
• Acts as an advisor to subordinate(s) and cross-functional partners, providing guidance to meet schedules and/or resolve technical problems effectively, develops schedules and performance requirements, and may have budget responsibilities.
• Cultivates effective relationships, shares knowledge, provides influence over projects and peer groups, demonstrating full understanding of area of specialization, and possesses working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and ISO 9001.
• Establishes and improves Quality & Regulatory (Q&R) capabilities supporting customer services business and leads in design and deployment of customer service strategy and solutions which exceed customer expectations.
• Independently produces CAPA records and performs timely Corrective and Preventive Action (CAPA) engineering tasks, including assessment of issue descriptions and reviewing CAPA data sources.
You're the right fit if:
- Education: Bachelor's Degree/ Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
- Experience: 7+ years of experience with Bachelor's or 5 years of experience with Master's in areas such as Quality Engineering, Safety Engineering, Process Engineering or equivalent.
- Certifications: ASQ CQE or CQM . 13485 auditor.
- High-level English language proficiency including strong writing skills
- 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.
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.
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 commitment to diversity and inclusion here.
Philips Transparency Details
The pay range for this position is $76,000 to $130,000, Annually. The actual base pay offered may vary 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.
#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/Disabled/Veteran and maintains a drug-free workplace.
