Senior Development Engineer (Medical Device / Sustaining)As the Senior Development Engineer your expertise and contributions will have a significant impact on improving and saving lives around the world by supporting Philips’ innovative Peripheral/Coronary Vascular, and Heart Rhythm Management products.Your role:
Serving as a technical expert/leader in a cross functional sustaining engineering team in support of detailed design and testing within R&D sustaining engineering projects, ensuring product designs meet specifications, and identifying and recommending solutions for complex technical issues and product improvements.
Activities include designing product and process improvements, prototyping, test method development and execution, and test protocol and report writing.
Supporting research and development activities for existing products and processes
Collaborating with cross-functional team members to ensure the continued success of your product lines.
Assessing component and product non-conformances and providing root cause analysis and recommended actions
Making data driven decisions using appropriate analytical methodologies
Creating and documenting design changes using SolidWorks as well as specifications for device components, assemblies, packaging, and labeling.
Working with process development engineers to ensure that products are optimally designed for manufacturing.
Assisting in the identification and selection of outside suppliers and consultants as required
Preparing for various design reviews in accordance with regulatory and quality system requirements.
Verifying that designs meet functional requirements through the performance of engineering analyses and testing. Establishing test methods, acceptance criteria, and test equipment, conducting hand-on testing, and writing test reports
Coaching and mentoring other sustaining engineers on the team.
You're the right fit if:
You’ve acquired 10+ years combined experience in product and process development for medical devices with extensive experience in FDA regulated medical device development, along with strong working knowledge of FDA Quality System Regulations, ISO 13485, etc.
You have a background working in material science (polymers, plastics, resin, etc.). Catheter experience would be highly preferred.
Your skills include a strong understanding of regulatory/notified bodies requirements and their auditing practices.
You have a BS Degree in Engineering (Mechanical, Chemical, Material Science, Physics, etc.) (MS Degree preferred).
You have analytical knowledge to drive data driven decisions throughout the development cycle as well as design for manufacturability knowledge and applicable skills.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
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 are not expected for this role. For this position, you must reside in or within commuting distance to Colorado Spring, CO, Plymouth, MN or San Diego, CA.
About PhilipsWe 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.
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Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
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Read more about our employee benefits (https://www.careers.philips.com/na/en/best-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 (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency DetailsThe pay range for this position is $116,000 to $199,000, 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 (https://www.careers.philips.com/na/en/best-employee-benefits) .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.#LI-PH1#LI-HybridIt is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran