Senior Design Quality Assurance Engineer
Job TitleSenior Design Quality Assurance EngineerJob DescriptionExciting opportunity to play a critical role in supporting Image Guide Therapy (IGT) Product Development and Sustaining projects, with respect to software, firmware, and hardware.
Your role:
Ensure appropriate quality planning, support quality plan design, provide effective oversight and hands-on execution of the Quality Plan, including Risk Management (ISO 14971) for all design related activities throughout the product development/system lifecycle.
Performs independent technical assessment on product quality performance and post-market product quality analysis.
Responsible for leading quality related problem solving and root cause analysis during design and manufacturing.
Provides other quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.
Acts as a single point of contact (person assigned to project team) responsible to ensure that design meets quality and compliance standards for every milestone.
Reporting to the Senior Manager-Laser Atherectomy & Catheters, you will partner with R&D, Regulatory Production/Manufacturing team members/stakeholders.
This hybrid role can be based in Colorado Springs, CO, San Diego, CA or Plymouth, MN and may require travel up to 10%.
You're the right fit if:
You've acquired a minimum of 7 years' experience in FDA regulated medical device environments, with a focus in Design Quality/Control and expertise in applying ISO 13485, ISO 14971, IEC 60601 and working knowledge with IEC 62304.
Your skills include Validation of key design inputs:
usability, reliability, performance, supportability, manufacturability, localization, safety, security, privacy, serviceability, sustainability, and costs.
You have proven leadership abilities, strong analytical & problem-solving skills, have used post-market analytics/statistics to report on product quality performance in the field, initiated field actions, experience with Statistical software solutions such as JMP or Minitab and Knowledge of Non-Product Software Validation (IQ/ OQ/ PQ), manufacturing processes and experience with methodologies/concepts such as Design for Reliability (DfR), Agile and SAFe.
You have a minimum of a Bachelor's Degree in a Quality, Engineering or related Scientific discipline (required), Master's Degree desired.
ASQ-CQE or similar certifications (preferred).
You're familiar with systems engineering tools, including software tools such as, design traceability, defect tracking and management tools such a Jira or Clearquest You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position 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.
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.
Read more about our employee benefits.
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 $96,000 to $178,000, 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.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Recommended Skills Agile Methodology Analytical Data Analysis Defect Tracking Engineering Support Firmware Estimated Salary: $20 to $28 per hour based on qualifications.
Your role:
Ensure appropriate quality planning, support quality plan design, provide effective oversight and hands-on execution of the Quality Plan, including Risk Management (ISO 14971) for all design related activities throughout the product development/system lifecycle.
Performs independent technical assessment on product quality performance and post-market product quality analysis.
Responsible for leading quality related problem solving and root cause analysis during design and manufacturing.
Provides other quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.
Acts as a single point of contact (person assigned to project team) responsible to ensure that design meets quality and compliance standards for every milestone.
Reporting to the Senior Manager-Laser Atherectomy & Catheters, you will partner with R&D, Regulatory Production/Manufacturing team members/stakeholders.
This hybrid role can be based in Colorado Springs, CO, San Diego, CA or Plymouth, MN and may require travel up to 10%.
You're the right fit if:
You've acquired a minimum of 7 years' experience in FDA regulated medical device environments, with a focus in Design Quality/Control and expertise in applying ISO 13485, ISO 14971, IEC 60601 and working knowledge with IEC 62304.
Your skills include Validation of key design inputs:
usability, reliability, performance, supportability, manufacturability, localization, safety, security, privacy, serviceability, sustainability, and costs.
You have proven leadership abilities, strong analytical & problem-solving skills, have used post-market analytics/statistics to report on product quality performance in the field, initiated field actions, experience with Statistical software solutions such as JMP or Minitab and Knowledge of Non-Product Software Validation (IQ/ OQ/ PQ), manufacturing processes and experience with methodologies/concepts such as Design for Reliability (DfR), Agile and SAFe.
You have a minimum of a Bachelor's Degree in a Quality, Engineering or related Scientific discipline (required), Master's Degree desired.
ASQ-CQE or similar certifications (preferred).
You're familiar with systems engineering tools, including software tools such as, design traceability, defect tracking and management tools such a Jira or Clearquest You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position 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.
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.
Read more about our employee benefits.
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 $96,000 to $178,000, 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.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Recommended Skills Agile Methodology Analytical Data Analysis Defect Tracking Engineering Support Firmware Estimated Salary: $20 to $28 per hour based on qualifications.
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