In this role, you have the opportunity to:
Manage research and development activities from concept stage of Product Development Process (PDP) projects through Commercialization. This person will lead detailed design and testing of new products and processes under development, ensuring that product designs and processes meet specifications, and identifying and recommending solutions for complex technical issues. Activities include new product idea development and proper documentation, prototyping, product specification development, test method and process development, test protocol and report writing, and facilitating technical team meetings regarding these topics.
This position may act as a technical lead on development projects, assisting the Program Manager in creating the project schedule, ensuring that technical tasks performed by engineers on the project team are executed on time and in compliance with the design and development plan, conducting technical team meetings, coordinating the activities of R&D engineers as well as cross functional resources.
You are responsible for:
Managing research and development activities from Concept Phase through Commercialization.
Coordinating and/or participating in events that provide clinical feedback and guidance, such as physician interface meetings and animal studies.
Translating user needs and other customer input into clear, concise design requirements and design concepts.
Creating and document design concepts through the use of 3D CAD software and rapid prototyping methodologies
Developing concept models and prototypes utilizing small tools and equipment.
Creating specifications for device components, assemblies, packaging, and labeling.
Working with Manufacturing and other Product Development engineers to ensure that products are optimally designed for manufacturing.
Providing technical leadership on process design, from high-level technical strategy to detailed production system documentation.
Assisting in the identification and selection of outside suppliers and consultants as required.
Preparing for and conduct various design reviews in accordance with regulatory requirements.
Verifying that designs meet functional requirements through the performance of engineering analyses and testing.
Assisting in the development of test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
Preparing for and facilitate risk assessments throughout the product development lifecycle.
Establishing test methods, acceptance criteria, and test equipment for all stages of product development.
Utilizing common laboratory test equipment to establish relevant bench and animal testing models and perform hands-on mechanical and electrical testing as needed.
Analyzing test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
Specifying fixtures, gauges, and equipment needed for the verification and manufacture of small quantities of prototype devices.
Working with patent counsel to prepare invention records and assist in the patent submission process.
Providing technical support to manufacturing engineering for design and process improvements made post transfer to sustaining manufacturing.
Participating as a member of a Product Development project team. The role of the PDE is to contribute to the technical aspects of project including product design, verification, and validation.
Meeting overall project deliverables and objectives.
Ensuring that development activities are documented through lab notebook, history file, and other records.
Solving complex problems where analysis of situations or data requires an evaluation of intangible variance factors
Providing independent judgment in developing methods, techniques, and evaluation criteria for product related research and development.
Providing technical guidance, coaching and mentorship to engineers to promote growth and development.
To succeed in this role, you should have the following skills and experience:
B.S. / B.Eng. in Mechanical Engineering or a relevant engineering discipline or equivalent work experience. M.S. / M. Eng. Preferred.
10+ years working in product development in the medical device industry with a minimum of 5 years’ experience with catheters and catheter-based systems
Knowledge of catheter assembly processes (extrusion, braiding, coiling, reflow, etc.)
Working knowledge of both FDA and CE design controls
Extensive experience with Solidworks is required
Strong technical writing ability and experience writing product requirements, specifications, test protocols, and test reports
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates
Experience designing products, subassemblies, and/or components
Experience with process development
Understanding of device testing in both in vitro and in vivo environments
Leadership ability and organizational skills
Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
Execute tasks in a timely manner without direct supervision
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 improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.