דרושים Design Quality Engineer ב-Philips ב-United States, Colorado Springs

Your role

• Learn and support global Post Market Surveillance including complaint intake, investigation, Vigilance reporting, record review, record closure, Issue Impact assessments, Correction and Removal, and Corrective and Preventive Actions.
• Evaluate and resolve complaints, initiate Issue Impact Assessments and CAPAs, analyze complaint data, other additional data as needed.
• Provide feedback and support as the team improves and aligns the Post Market process for Philips IGTD
• You will work with the global Post Market unit which interacts with all quality departments, Research & Development, Clinical/Med Affairs, Engineering and Senior Management.
• Gain real life experience in a regulated industry, exposure and interaction with cross functional departments globally.

You're the right fit if

• You are pursuing a Science, Technology, Engineering, or Math based undergraduate degree with at least 2 years of education completed
• Your skills include technical knowledge, communication, research and critical thinking, problem solving attention to detail, resilience, and teamwork
• You’ve acquired 2+ years of experience in college/University and/or previous internships or coops, no direct work experience necessary just a desire to learn and work in a team as an individual contributor
• 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
• You’re eager to learn and drive for results
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this

How we work together

This is an office role.

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 .
• Discover
• Learn more about
• Learn more about .

The hourly pay range for this position is $25.00 to $28.00, plus overtime eligible. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Details about our benefits can be found .

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.

be provided for this position. For this position, you must reside in

In this role you

You are responsible for creating and executing comprehensive process validation strategies to ensure new products transition seamlessly to production, adhering to quality and regulatory standards. The role executes the full design control process, including validation and design transfer, and ensures accurate and up-to-date quality engineering documentation.

Your role:

• Creates and executes comprehensive Design Test Method Validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
• Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
• Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality.

You're the right fit if:

• Bachelor's Degree/ Master's Degree inMechanical Engineering, Electronics Engineering, Science or equivalent.
• Minimum 2+ years experience in Design Quality Management in Medical Device.
• Prefer 5+ years of experience with Design, Test Validation, Usability, Reliability, Performance, Manufacturability, Safety, Audit, CAPA.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together

This is an office role.

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 .
• Discover
• Learn more about
• Learn more about

.

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.

will notbe provided for this position. For this position, you must reside in

Your role:

• Develop and Review SW Design Verification Plans, Protocol and Reports. Conduct SW Design Verification per SW Design Verification Plan and Protocol. Developing and Reviewing Quality plans.
• Leading and supporting the development, design verification and hypercare of non-product software assessments and qualification efforts.
• Leading the creation and review of risk management file to include the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.
• Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software.
• Serving as SME for Software Design Assurance and collaborate with teams on code review, unit tests, software security analysis, defect and vulnerability triage, creation and review of sBOMs, etc. and leading implementation of best practices for software quality processes.

You're the right fit if:

• B.S./ M.S. in relevant engineering field (e.g. Biomedical, Computer Science, Software Development, Electrical etc.)
• 8+ years of experience in Software Quality and/or Software Development in medical device industry with hands on experience with SW Design verification and/or development.
• Expertise in applying 21 CFR 820, ISO 13485, IEC 14971 and IEC 62304 and working knowledge with IEC 60601 and other relevant medical device standards
• Experience with software development lifecycle mythologies including Agile and SAFe,Defect tracking and management tools such a Jira or Clearquest.Statistical software solutions such as JMP or Minitab,Requirements and Traceability management tool such as JAMA, IBM DOORs etc.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together

This is an office role.

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 .
• Discover
• Learn more about
• Learn more about

.

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.

The Maintenance Engineer is responsible for initiating cross-unit continuous improvement initiatives, introducing new products, consulting with specialists for optimal execution methods, utilizing Root Cause Analysis for problem-solving, conducting equipment inspections, diagnosing technical issues under general supervision, and ensuring adherence to safety protocols for operational efficiency and innovation.

Your role:

• Utilizing digital voltage meters, temperature meters, and various hand tools you will perform manufacturing equipment corrective service on more than 800 pieces of equipment. You will perform qualifications for all tools used in production completing and submitting documentation in a timely manner.
• Diagnose low to mid complex mechanical, electrical, and other technical issues. Able to read schematics and troubleshoot effectively. Ability to escalate to others for help as needed while working under time pressure.
• Understanding of basic electrical theories and knowledge of laser and vacuum systems is a plus.
• Adheres to safety protocols and guidelines meticulously during the execution of maintenance tasks to ensure a secure working environment and prevent accidents or injuries.
• Experienced working with all Microsoft products. Working with Maintenance Connection, Ariba, SAP, Windchill and in an FDA regulated environment is a plus.

You're the right fit if:

• You’ve acquired 2+ years of experience in supply chain related functions or equivalent with Vocational education or no prior experience with bachelor’s degree
• You have a High school diploma, Vocational education or bachelor’s degree in Industrial, Electrical or Electronic Engineering or equivalent.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

How we work together

This is onsite role.

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 .
• Discover
• Learn more about
• Learn more about

The pay range for this position in CO is $27.58 to $44.13 an hour.

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.

You will sustain and maintain labeling system software, hardware and processes in a medical device manufacturing environment.

Your role:

• Develop and maintain a complete labeling system (software, processes and equipment) for complex medical devices.

• You are responsible for: the development sustaining of a complete labeling system solution software; the quality and compliance of medical device labeling; internal and external database management; validation activities (software and hardware); and departmental work instructions/processes.

• Deployment and administration of a complete labeling system, including documented Work Instructions (WIs) and departmental Standard Operating Procedures (SOPs).

• Ensuring timely change management of labeling and Instructions For Use (IFUs), working with labeling technicians/label coordinators, and performing labeling changes.

• Quality management and all life-cycle phases of product labeling and IFUs. Leadership, both direct and indirect, will be an expectation of this role as a growth path.

You're the right fit if:

• You’ve acquired 1+ year of engineering experience in medical device or other highly regulated industry.
  Your skills include supporting quality related investigations and changes involving labeling materials and/or labeling processes, such as NCRs, CAPA, SICRs, IIAs, Audit Support questions, Equipment Events, Regulatory Gap Assessments, etc.

• You have a B.S. in Engineering.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

• You’re an excellent communicator that is detail oriented and well organized.

How we work together:

This is an office-based role.

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 .

• Discover

• Learn more about

• Learn more about

The pay range for this position in CO is $71,250 to $114,000

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.

• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN .

Working under the oversight of experienced engineers, you will be a contributing member of a technical sustaining team improving and maintaining our released surgical products

Your role:

• Responsible for changes to existing products given specific input requirements and constraints.

• Generating design documentation such as CAD models, drawings, BOM, test protocols, test reports, Design Input and Output documents, and Engineering Change Tasks.

• Producing prototypes for evaluation, development, and test, which may include assembly and limited machining.

• Working with vendors on component design, fabrication, and supplier-initiated change tasks.

• Developing and executing engineering studies, analyzes data, provides recommendations

You're the right fit if:

• You’ve acquired 3+ years of experience in sustaining engineering or product development in medical devices (other regulated industries could be considered). A solid working knowledge of FDA Quality System Regulations and ISO 13485, and ISO 60601 would be beneficial.

• Your skills include proficiency in SolidWorks with the ability to create both solid models and finished drawings. Additional proficiency in statistical analysis software, with Minitab preferred.

• You have a bachelor’s degree in mechanical engineering* with a solid understanding of mechanical systems and the fundamental toolset for mechanical design as well as strong technical writing skills. (*similar degrees could be considered).

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

• You must be able to read and understand drawings, schematics, and data.

How we work together:

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 .

• Discover

• Learn more about

• Learn more about

The pay range for this position in CO is $70,000 to $110,000

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.

• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Colorado Springs, CO .

Your role

Work with all key suppliers of Image Guided Therapy and Cross Functional teams (R&D and Quality) to enhance Supplier maturity through Design Quality and Product Quality.

• Analysis of defects for determining if supplier caused

• Support Supplier Corrective Action Requests

• Support APQP deliverables as parts of Sustaining Changes

• Contribute to Supplier performance monitoring, reporting, improvement and development

• Supports with Additions/Changes/Deletion to Approved Supplier List

• Support Supplier audit schedule development and maintenance.

• Assess and coordinate Supplier Change Requests.

You are the right fit if

• You are pursuing a technical engineering deree: Bachelor or Master Degree of Industrial Engineering, Chemical Engineering, Electrical, Mechanical or similar.

• Experience to driving root cause analysis to perform problem solving strategies

• Work closely with cross functional team and SQEs across all sites of IGTD to address none-conformances.

• Visit Suppliers as needed to review corrective actions.

• Review Design of parts to understand impact to patient safety.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position

How we work together

This is an office role.

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 .
• Discover
• Learn more about
• Learn more about .

The hourly pay range for this position is $25.00 to $28.00, plus overtime eligible. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Details about our benefits can be found .

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.

be provided for this position. For this position, you must reside in