We welcome you to join Philips Image Guided Therapy Devices (IGT-Deveces) as a Principal verification and Validation R&D Engineer in our San Diego, CA location.
You are responsible for
- Provides technical expertise to the design and development of new invasive and noninvasive medical device product(s), with a focus on the verification and validation phases of design controls. Investigates/evaluates existing technology and advises research and development, regulatory affairs, and reliability engineering to ensure appropriate process development, test method development, and specification development under the best possible conditions. Designs and implements new methodologies, materials, machines, processes, or products. Develops new concepts from initial design to market release. Conducts feasibility studies of the design to determine ability to function as intended. Maintains detailed documentation throughout all phases of research and development. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines
- An expert in the field of medical device development, verification, and validation. Able to teach design controls, documentation responsibilities, and defend in audits. Ability to mentor engineers and technicians is a top priority. Expert knowledge and experience with Regulatory requirements associated with design controls. Assists/leads in development of Regulatory Submission Strategies. Leads cross-functional team that proactively investigates, identifies and implements best-in-class practices & processes within site. Leads creation of V&V strategy and protocols, point person for execution of V&V testing, and leads V&V investigations. Leads teams in identify CTQ’s and KPIV’s for large complex designs, with special attention paid to impact on product specification, test method, and V&V activities. Leads multiple disciplines in translating the CTQ’s into measurable parameters. Master of (long track record) complex capability analysis. Works to establish methodology of DOE and Capability Analysis and mentors others.
- Fully versed in functional management guidewire designs and the interfacing console/software components. Strong understanding of system level requirements and interactions. Internal advocate for the end user.
- Ensures best practices for development and validation of new test methods. Coordinates verification and validation studies. Independently writes test plans and reports. Develops functional strategy on/provides training on statistical methods, tools, verification, and validation methodologies. Conceptualizes, designs, develops and documents large-scale designs and systems, complex in scale. Based on customer inputs, leads team in development of new catheter/disposable designs, including transducers and other functional measurement devices. Optimizes existing designs. Leads/supports the development of process maps, value stream maps, CAD drawings, and schematics. Defines, performs and analyzes complex linear experiments and complex DOE’s. Provides consultation to others. Provides consultation and/or leads root cause analysis and implementation of corrective actions.
- Directs internal/external teams in design, building and testing. Focuses on team leadership by independently identifying gaps in team competencies, developing strategy for team development, and focusing on mentoring activities. Ensures best practices are used for transfer of new designs from R&D to production.
- Lead on medium to large complexity design and development efforts. Able to plan and conduct moderate level research and/or development efforts (GLP). Particular focus paid to development convergence at verification and validation activities. Develops strategies and writes advanced technical reports and test plans. Coordinates verification and validation studies. Oversees the generation of test methods and procedures for evaluating designs, processes and products. Establishes standards for design, verification, and validation documentation within functional area. Consults on and provides guidance on technical design reviews across product lines.
- Operates as a leader within the FM development group and the broader R&D department. Mentors engineers and technicians in all design control methodologies, with particular focus paid to verification, validation, and test method development. Advocates /trains/teaches discipline(s) across organization. Participates in development efforts as a Medical Device Development Core team representative. Leads cross-functional team(s) that proactively investigates, identifies and implements best-in-class practices and processes within the site
- Promotes the advance of scientific knowledge and collaborations with fundamental research through participation in scientific and engineering conferences. Publishes results of internal work or internal-external collaborations. Defines and executes disposable device performance testing. Develops domain knowledge based on technical and academic literature. Researches new materials and adapts those materials and equipment into design and development processes.
- Communicates as an internal consultant to senior management and customers on new or projected areas of technological research, applications and advancements. Establishes and cultivates an extensive network of support from other functional areas and outside resources. Interfaces with Program Managers and industry leaders on catheter/disposable design, development and production and definition of user requirements.
- Broad expertise or unique knowledge; uses skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways. Applies advanced technical principles, theories, and concepts. Contributes to the development of new principles and concepts. (Multi-discipline, multi-domain, systems) Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results.
Skills and Experience
- Bachelors of Science and a minimum of 10 years of relevant work experience; or a Master Degree with a minimum of 8 years of relevant work experience; or a PhD with a minimum of 5 years of relevant experience; or equivalent work experience. (Mechanical Engineering, Material Science, Plastics Engineering, or Biomedical Engineering preferred).
- Demonstrate organizational, leadership and interpersonal skills working in a cross-functional, regulated environment.
- Passionate about mentorship and development of others.
- Ability to lead and work in a team environment to ensure conducive working relationships.
- Excellent analytical, training and motivational skills.
- Ability to organize and prioritize workflow in order to meet established time-frames and schedules.
- Assimilate techniques from scientific literature and other external sources.
- Develop intellectual property and support patenting process.
- Remain current in discipline and domain.
- Experience with cardiology catheterization procedures, tools, and terminology
- Ability to travel up to 25% (domestic and international locations)
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.