Senior Design Quality Engineer
Job Description
- Accountable for oversight of system and hardware quality and risk management throughout the product life cycle.
- Provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field.
- Ensures appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design.
- Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
- Performs independent technical assessment on product quality performance and post-market product quality analysis.
- Uses post-market analytics and statistics to report on product quality performance in the field and initiates field actions when required.
- Bachelor's/Master's Degree Engineering or equivalent.
- 5+ years of experience in Product development, Design Quality, Risk Management for medical device.
- Knowledge of 13485 / 9001 / FDA / Canada / 14971/ standards.
- FMEA/ Root Cause Analysis/ Problem solving.
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
Job Description
Senior Design Quality Assurance Engineer
In this role you
The Senior Design Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. The Senior Design Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The Senior Design Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes.
Your role:
- Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
- Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
- Provides effective oversight of the execution of the Quality Plan , any Risk Management activities, and of all design related activities during the product/system lifecycle
- Performs independent technical assessment on product quality performance and post-market product quality analysis
- Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
You're the right fit if:
- Bachelor's/Master's Degree Engineering or equivalent
- 5+ years of experience in Product development, Design Quality, Risk Management for medical device.
- Knowledge of 13485 / 9001 / FDA / Canada / 14971/ standards
- FMEA/ Root Cause Analysis/ Problem solving
- 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 culture.
Transparency Details
The pay range for this position in Plymouth MN is $92,000 to $135,000 Annually.
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.
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 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 , 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.
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.
#LI-PHI
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
