Electro-Mechanical Medical Device Design Quality Engineer

Job Title

Electro-Mechanical Medical Device Design Quality Engineer

Job Description

Design Quality Engineer

In this role you

The Electro-Mechanical Medical Device Design Quality Engineer facilitates in providing quality oversight of system, hardware, and risk management throughout the product life cycle, independent oversight of the system design input process, design of Verification and Validation (V&V) activities, and performance in the field, working under limited supervision. The role independently produces quality engineering documents, executes assessment of product and system designs, and validates key system design inputs.

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.

• 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.

• 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:

• Bachelor's Degree required.  Master's Degree preferred in Mechanical Engineering, Electronics Engineering, Science or equivalent.

• 5+ years of experience in Design Quality Engineering, Safety Engineering, Product/Process Engineering.

• ASQ CQE or CQM . 13485 auditor certifications.
• Knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and ISO 9001.

• 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 commitment to diversity and inclusion.

Philips Transparency Details

The pay range for this position in Latham, NY is $75,000 to $130,000, Annual