R&D Development Engineer

Company: Philips
Location: Colorado Springs
Posted on: May 28, 2023

Job Description:

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*.--- Employees may request a reasonable accommodation. --- *Montana employees are currently excluded from this requirement at this time.
If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request.--- You may contact 888-367-7223, option 5, for assistance.
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it's not just what we do, it's who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.
The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.
Work alongside experienced engineers, you will be a contributing member of a technical team developing new, innovative medical products . Your tasks will include managing innovation programs in the early developmental stages of new products and solutions supporting fiber atherectomy applications.
Develop the mechanical design of selected product elements; design documentation creation and management; and test protocol development, execution, and data analysis. You will perform your duties as an integral member of a multi-functional team working to develop all aspects of the new product in a highly collaborative environment.
You are responsible for

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  Managing complex innovation programs using the latest tools and innovation approaches to improve predictability of completion on a defined schedule and budget.
  
  
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  Developing technical solutions to a wide range of complex problems that turn ideas into clinically and economically valued business solutions.
  
  
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  Detailed design specifications related to the fiber atherectomy portfolio.
  
  
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  Execution of product changes regulated by design controls; translation of customer requirements and user needs into product requirements.
  
  
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  Appling strong organizational and/or project management skills.
  
  
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  Leading the technical development of product and/or process developments.
  
  
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  Assessing risks and opportunities during process improvement deployment.
  
  
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  Understanding New Product Introduction (NPI) and sustaining product lifecycle.
  
  
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  Developing a strong working knowledge of functional areas outside of R&D required for product development, product industrialization, and sustaining engineering, i.e. Quality, Regulatory, Product Safety, Finance, Sales, Marketing and Clinical.
  
  
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  Engaging in Cross-functional discussions and conflict resolution to improve systems and processes.
  
  
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  Driving data based decision-making efforts based on technical findings and/or threats in the marketplace; makes decisions while factoring input and perspective from cross-functional team members.
  
  
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  Making sure to elicit, prioritize, and always balance requirements.
  
  
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  Developing and creating continuous improvement of processes.
  
  
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  Managing and provide protection to products and technologies through appropriate use of patents and trade secrets.
  
  
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  Delivering clear communication both written and verbal in a logical and succinct manner. Can effectively present project plans and results to various management functions.
  
  
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  Authoring technical (controlled) documentation.
  
  
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  Appling detailed knowledge and expertise of Quality Management Systems per ISO 13485, 21 CFR 820, and EU MDR Requirements; Risk Management ISO 14971 and industry standards. (i.e. IEC 60601)
  
  
  You are part of
  A great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn from our Engineers, Clinicians, Sales Leaders, and other industry professionals about all facets of state of the art medical device development. You will be exposed to clinical leaders to understand the needs behind the products you help to develop.
  To succeed in this role, you'll need a customer-first attitude and the following
  
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    Bachelor of Science in Engineering (Mechanical, Biomechanical or Biomedical)
    
    
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    Minimum of 3 years combined experience in product and process development within a regulated environment
    
    
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    Experience with material selection, knowledgeable of material sciences and processes (i.e. injection molding, extrusion); rapid prototyping techniques
    
    
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    Demonstrated communications skills to enable effective contribution as a member of a multi-functional team is essential
    
    
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    Experience and proficiency in design utilizing tools such as SolidWorks
    
    
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    Experience in a regulated industry required (medical device development experience along with a solid working knowledge of FDA Quality System Regulations and ISO 13485)
    
    
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    Experience with medical devices required
    
    
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    Deep understanding of regulatory/notified bodies requirements and their auditing practices
    
    
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    Approving project expenses to a given amount level
    
    
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    Six sigma / Lean / Continuous improvement
    
    
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    Creating / Writing / Establishing Standard Operating Procedures
    
    
    In return, we offer you
    The opportunity to learn from our engineers, clinicians, sales leaders, and other industry professionals about our state-of-the-art laser systems and disposable products. The opportunity to become a highly influential subject matter expert for software engineering in our products. The opportunity to be among experts and leaders in the medical device industry who are dedicated to creating a dynamic, challenging working environment and who will support your continued growth.
    US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
    Company relocation benefits will not be provided for this position. For this position, you will reside in or within commuting distance to Colorado Springs, CO
    How we work at Philips
    Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.---
    Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
    Our hybrid working model is defined in 3 ways:---
    We believe in the importance of impactful collaboration: There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
    We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis. ---
    We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. ---
    Why should you join Philips?
    Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
    Visit our careers website to explore what it's like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.
    #LI-PH1
    It 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

Keywords: Philips, Colorado Springs , R&D Development Engineer, Engineering , Colorado Springs, Colorado