Job Title

Job Description

The Principal Design Assurance Engineer will serve a critical role in leading Design Assurance/Risk Management activities on new Image Guided Therapy Device (IGTD) product development projects, ensuring project/business objectives are met.

Your role:

• Responsible for updating risk documents, component qualification, statistical analysis of data, design verification and process validation planning as well as quality system compliance. Provide critical review of design requirements, justifications, rationales, protocols, deviations, test methods and training requirements.
• Will ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk Management for medical devices.
• Actively evaluate projects for opportunities to improve performance or accelerate learning; continuously monitors risk and mitigates as appropriate. Provides critical quality review of design requirement rationales, test methods, and test method validation/training requirements.
• Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will ensure specific quality levels. Experienced in component inspection and testing techniques; must be able to read and interpret blueprints.
• Participate in the development and results analysis of verification and validation plans and test protocols to qualify and validate new product designs and processes.
• Works with cross functional team (R&D, NPI, NPD and Advanced Development) to complete component qualification activities, plan and conduct design verification/validation testing and process validation activities. Serve as a technical expert for problem investigations to guide root cause analysis and corrective action development. May directly supervise one or more technicians or engineers.

You're the right fit if:

• You have a minimum of 8 years’ experience working within FDA regulated medical device environments (vascular medical devices/ electromechanical systems preferred), with a focus in design control/assurance, risk management, FMEA’s, PHA’s, Root cause Analysis, etc.
• You have successfully supported new product development cycles, with a deep understanding of how to apply Design/Process Controls and expert knowledge of 21 CFR part 820, ISO13485, ISO 14971 and IEC 60601.
• You’re able to lead a team in completing Risk Management activities (PHA, FMEAs, Risk Management Report, and compliance tables for IEC 60601) and able to specify Design, Use and/or Clinical FMEAs.
• You have proven experience conducting Human Factors /Usability studies/testing, data/statistical analysis and in leading test method validation (TMV) activities.
• You’re able to recommend sampling plans, equipment requirements, measurement techniques and training requirements-based on risk.
• You have a minimum of a Bachelor’s Degree in Engineering (required) Mechanical, Chemical, Electrical, Biomedical or similar disciplines.
• 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:

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 Plymouth, MN is $109,000 to $187,000.

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 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.

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.
• May require travel up to 10%.

#LI-PH1

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.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.