Philips Manufacturing Engineer, Philips Healthcare, (Highland Hts., OH.) in Highland Heights, Ohio

Manufacturing Engineer , Philips Healthcare, (Highland Hts., OH.)

Summary Description:

Responsible for supporting production in driving process improvements with cross functional teams and driving New Production Introduction for Computed Tomography (CT)/Advanced Molecular Imaging (AMI) Global Operations. Responsible to drive excellence in Operations and in New Product Introduction transfers as demonstrated by world class quality, cost and delivery performance.

Key Areas of Responsibility:

Support CT/AMI Production Lines through the following activities;

Disposition of non-conforming product, including troubleshooting, writing of repair/replace procedures, and processing of non-conforming documentation

Writing, revising, and training to work instructions and datasheets

Processing changes in order to ensure that the production lines are running, including serving on change control board and ensuring that the change is implemented in the factor correctly

Support New Product Introductions and Other Projects

Support NPIs as an operations lead or extended team member in order to ensure effective design Transfer to production

Take ownership role or serve as team member on smaller projects in order to drive improvements in the plant. Some of these examples could be lean implementation projects, parts obsolescence projects, line balancing and optimization activities, tooling and test fixture design and Implementation, or root cause analysis of failures.

Work with global suppliers and manufacturing sites in order to ensure consistent products are produced and best practices are shared between facilities.

Lead or Support all aspects of process validation including Installation Qualification (IQ), Equipment Qualification (EQ), Operational Qualification (OQ), Inspection Verification (IV), TMV (Test Method Validation), and PQ (Performance Qualification)

Support Process Validation for products in production, new product introductions, and supplier processes.

Compliance to Regulations and Quality Management System (QMS)

Complete documents in a clear, concise, and compliant manner.

Comply with Good Documentation Practices on all documentation.

Conduct work in compliance with the regulations and the (QMS) at all times.

Minimum Qualifications:

• Bachelor’s degree in Electrical/Mechanical/Biomedical/Industrial or any other Engineering discipline or related field.

• 3-5 years of relevant experience

Desired Qualifications:

• Master’s degree in engineering or similar discipline

• 3-5 years working in a regulated industry.

• Experience with Leading Small Scale Process Validation Activities, Including IQ, OQ, PQ, TMV, and IV, and PFMEA.

• Experience in implementing production efficiency tools such as Poka-Yoke, Value stream mapping, Lean, and Six Sigma tools

• Experience in implementing and qualifying In-circuit test, Functional test, Test Automation, or other test fixtures.

• Knowledge of driving 483, warning letters, remediation activities for a FDA regulated industry

• Six Sigma Green Belt or Black Belt


• Ability to work as part of a cross functional team in order to complete tasks on time and with quality and compliance.

• Ability to lead others through influence in order to meet common goals and objectives.

• Ability to define timelines, scope deliverables, and track performance for projects, generally those with < 5 people and duration of 3 mo.

• Experience in practicing root cause analysis, lean manufacturing, and/or process validation.

Knowledge of FDA regulations and Good Documentation Practices.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

Our Offer :

At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care. Named one of the Top 50 Happiest Companies in America in 2013, we enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.

Here at Philips WE ARE Working Together for a Better Tomorrow:

Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.

Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.

Apply today!

Find out more info about Philips at

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation 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.