- Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacturing.
- Ensure that all appropriate documentation, drawings specifications are generated in compliance with Philips procedures and regulatory requirements (US FDA and ISO).
- Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
- Responsible for creating the code for the digital templates necessary to run the paperless factory.
- Knowledge of IQ, OQ, PQ Validation Strategies is highly desirable.
- Responsible for defining, selecting, and validating Manufacturing equipment.
- A Bachelor's degree in Engineering is required (mechanical, industrial, material science, electrical, or similar)
- A minimum of 5 years of Manufacturing Engineering experience
- Demonstrated strong analytical and problem-solving skills
- Ability to provide technical leadership in ambiguous situations
- Excellent communication (written and verbal), team leadership, and interpersonal skills
- Lean manufacturing experience
- Experience in creating, coordinating, and implementing engineering and business process changes
- Computer literate in MS Office Applications
- Experience in a regulated environment
- Lean manufacturing experience
- Experience with electronic device history record and electronic device master record systems
- Knowledge of Statistical Methods (Process Capability, SPC, Trend Analysis)
- Demonstrated experience with the validation, documentation, and manufacture of medical devices
- Green belt/black belt training or certification
- Knowledge of GMP ISO-14971, and ISO-13485 is highly desirable
- Basic understanding of software coding in any standard language
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
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Manufacturing Engineer - Bothell, United States - Philips
Description
Job Title
Manufacturing EngineerJob 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
As a Manufacturing Engineer, you will be responsible for managing the manufacturing of Philips AED products. Within this role you will have end-to-end responsibility for a production line, which includes part delivery, manufacturing and test flows, and packaging. You will implement and validate the changes required to meet maintain compliance with Internal documents and regulated industry requirements.
Your role:
In this role as a Manufacturing Engineer, you will focus primarily on supporting and improving the processes for AED manufacturing. Your responsibilities will include, but are not limited to:
• Provides first line engineering support to ensure smooth operation in production
• Provide technical support to resolve manufacturing and quality problems, including yield and nonconforming product. Drive corrective action with appropriate and detailed follow up.
• Identify, analyze, and implement cycle time improvements and lean manufacturing techniques to improve productivity.
• Work collaboratively with Product Industrialization to transition design changes into manufacturing.
• Identify, specify, coordinate, and validate installation of new manufacturing equipment and upgrades for process improvement.
• Create, update, and review pFMEAs for process instructions.
You're the right fit if:
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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 $74,000 to $136,000, 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.
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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
