Job Title: Senior Design Assurance Engineer
Job Description:
The Senior Design Assurance Engineer will play a critical role in support of the design controls process, with a focus on Sustaining and New product development (NPI) of Philips' Image Guided Therapy Devices (IGTD).
Your Role:
Ensures Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, and updating risk documents, component qualification, statistical analysis of data, design verification and process validation planning as well as quality system compliance.
Provides critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements.
Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will ensure specific quality levels.
Works with cross functional teams to complete component qualification activities, plan/conduct design verification (DVT) and process validation activities.
Participates in the development/results analysis of verification and validation (V&V) plans and test protocols to qualify and validate new product designs and processes.
Youre the Right Fit If:
You have a minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971) and strong understanding of all aspects of the QMS related to Design/Process Controls.
You have strong understanding of Medical Device QSR regulations/standards including ISO 13485, ISO 14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR.
You're able to analyze quality data and draw conclusions regarding trending, KPI's etc.
You have extensive experience supporting the creation and review of all medical device documentation including:
You have the proven ability to cultivate and maintain strong relationships with team members and internal/external stakeholders.
You have a minimum of a bachelor's degree in Quality, Engineering (Mechanical, Chemical, Biomedical) or a related Scientific discipline (required). ASQ certifications (desired).
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 we are 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 wont 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.
Philips Transparency Details:
The pay range for this position in Plymouth, MN is $91,350 to $146,160. 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.
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. 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.
Additional Information:
This role may require travel up to 10%. 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.
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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 including Disability/Vets and maintains a drug-free workplace.
At Philips, we don’t need employees. We need people.
Our goal is to improve the lives of 3 billion people a year by 2025 through innovation that is designed for people, by people. People like you. And we know that in order to be truly innovative, it requires you to make your career personally meaningful. To bring what matters to you in life to everything you do in your career. If you're passionate about improving lives, and have more to offer than just lines on your resume, we want to find a home for you at Philips.
As a diversified health and well-being company, we focus on professional and consumer markets across three interconnected sectors: Healthcare, Consumer Lifestyle, and Lighting. Today, we're a global innovation leader - the first to bring the commonly used CD and DVD products to market, the ones saving lives daily with our imaging systems and patient monitors, and the ones responsible for the lighting of the annual Times Square ball. We aim to improve peoples’ lives every day through meaningful innovations and are the best place to work for those who share our passion for improving lives.
Philips’ people first culture and commitment to providing unlimited possibilities to develop one's career in the directions to which they aspire demonstrates a dedication to inspiring good people, not just hiring employees. At Philips, employees enjoy contributing to cutting edge solutions that truly improve lives, allowing them to 'do good' while doing great and create a legacy in life through their work.
If you are interested in putting your personal skills & passions to work towards improving lives, apply now or learn more at philips.com/na/careers. You can also opt-in to receive updates on future career opportunities and company updates through Philips’ Talent Community, and follow @PhilipsJobsNA on Twitter.