Manufacturing Engineer

Job Title

Manufacturing Engineer

Job Description

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to

Your engineering expertise will drive Supply Chain efforts to improve Quality, Customer Satisfaction, and on-time delivery, reduce cost, assure materials supply, and advance operational excellence. In this space, attention to detail is of the utmost importance. We work in a fast paced, process driven environment building high quality medical devices that lead our industry and improve people’s lives.

You will be the single point of contact for assigned product lines, leading manufacturing engineering projects and implementations to maintain software centric medical device deployment for Philips products.

You are responsible for

• Manufacturing Line Set-up
  • Production Process (process flow, including takt time, line balancing, etc and supporting documentation)
  • Physical line set-up
  • Operator Training of Assembly Process
  • Collaboration of Transfer Plan with Product Industrialization team and R & D
  • Working with cross-functional teams to plan and execute Manufacturing Engineering activities in support of New Product Introduction.

• Manufacturing Line Maintenance & Monitoring
  • Be the single point of contact for yield levels and general process quality monitoring and improvements for the medical device. (MRB, DEFOA, QN, Manufacturing Holds, Continuous Improvement)
  • Manufacturing Responsibility (MR) for Engineering change notices
  • Utilize Philips information management systems to control bill of materials, manage engineering change orders, and interface to our Supply Chain process.
  • Managing quality / compliance enhancements, assurance of supply and new feature implementation through the entire product life cycle of the product providing Design for manufacturing support on Philips owned custom medical device assemblies.
  • Investigating and resolving product and process quality issues within Philips Quality System framework
  • Accountability for the overall device manufacturing performance, monitoring and continuous improvement, field failure trending and overall process support as well as associated regulation compliance and controls.

• Production Equipment Management
  • Initial Line Set-up
  • Calibration set-up / schedule
  • Trouble-shoot / repair of production test equipment
  • Implement improvements to equipment

• Process Validation
  • Manage the Validation Plan Matrix for the product line, and elements of the Pro
  • Elements of IQ/OQ/PQ in collaboration with Product Industrialization team and others as necessary
  • Documenting and executing verification and validation protocols for product and process changes.
  • Finalizing validation reports, procedure updates and associated Bill of Materials (BOM) updates.
  • Re-validate line/equipment as necessary

You are a part of

As part of Philips Healthcare’s Measurements Analytics business, we provide solutions that simplify clinician workflow, improve financial outcomes and help improve and save lives. To achieve that objective, we are employing state of the art methods to deploy and support our software on OEM hardware, the Web and smartphones.

This individual will be part of a high performing Operations engineering team that participates in all stages of product development from definition to delivery.

To succeed in this role, you should have the following skills and experience

• Engineering Degree or equivalent with 5 + years of experience in manufacturing operations environment preferably in medical device market
• Manufacturing development background with emphasis on Medical Devices, Software products, IT equipment and design for manufacturing experience
• Knowledge of FDA, GMP, and ISO standards for medical device manufacture, experience in eDMR / SAP strongly preferred.
• Excellent communication, teamwork, and interpersonal skills, experience with working across multiple sites and geographic locations and across a matrixed business entity environment.
• Experience with vendor management, software programming or CAD preferred.
• Desire and ability to work in a dynamic Medical Device Operations environment.
• Must have very strong interpersonal, communication and teamwork skills.
• Proven and demonstrated problem solving skills are required.
• Demonstrated experience with the validation, documentation, and manufacture of medical devices is a plus.
• Ability to travel internationally (less than 10%)
• Working knowledge of LabView, database and database structure, network and software download

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

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.

Equal Employment and Opportunity Employer/Disabled/Veteran

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