Design Assurance Engineer

Job TitleDesign Assurance Engineer

Job Description

Lead all quality elements of Design Controls and product DHF for new product introductions and sustaining/design projects.

Your role:

• Drive Quality norms associated with design engineering projects and lead Quality Plan initiatives associated with Risk Management and Quality System integration.
• Support integration of Risk Management processes throughout the product lifecycle from initial development through post market surveillance in accordance with Philips processes and global standards’ support integration of post market surveillance processes into Design Controls and Sustaining initiatives through analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues.
• Support the Regulatory Affairs department for submissions and respond to submission questions and support internal and external audits
• Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement initiatives.
• Analyze situations/data using engineering principles and collaboration to identify gaps between project work and QMS; quality responsibility for transfer of new products and sustaining projects to manufacturing and operations quality and supplier quality teams.

You're the right fit if:

• You’ve acquired 1+ years of experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a highly regulated industry

• Your skills include experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards, strong statistical background in verification, validation, hypothesis testing, sampling, multi-factor analyses and measurement system analysis, understanding of design quality tools, methods and activities, demonstrated expertise in managing complex projects and implementing cultural change, proven track record of completing projects on-time that meet all objectives

• You have a Bachelor of Science in Engineering, Sciences or a related field

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

• You have excellent customer service and interpersonal communication skills, experience leading presentations in front of peers and leadership; hands-on problem solver that drives solutions within teams; teamwork skills including influencing and building rapport with internal customers and stakeholders.

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 $59,535 to $102,060.

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 Plymouth, MN.

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.