Supervisor R&D, Product Development Engineering

Supervisor R&D, Product Development Engineering

#AJEDNP

#LI-DNI

#SKIP

TE Connectivity in Carlsbad, CA is looking for a Supervisor R&D, Product Development Engineering, responsible for the following:

User Research: (50% of time)

• Perform all aspects of project management, including development of budgets and timelines, client communication, protocol and report design, recruitment decisions and resourcing.
• Conduct research using a wide variety of qualitative and quantitative methods to generate actionable insights across the product development lifecycle, including generative research to identify new opportunities, iterative concept evaluation, and post launch testing for clients.
• Design, develop, and execute usability studies for various products, to suit the testing goal and stage of development.
• Moderate and manage team activities to facilitate study sessions.
• Structure, aggregate, and analyze performance and feedback data sets, applying specialized software tools for data analysis and design prototyping.
• Perform expert reviews, focus groups and contextual surveys.
• Participate in the risk management process and identify/evaluate usability-related risks, hazards, and hazard-scenarios.
• Communicate actionable insights and recommendations to engineers, clinical research team and clients to drive product development and regulatory validation.
• Write detailed reports in keeping with ANSI, AAMI and FDA guidelines and regulations.
• Support clients with human factors portions of regulatory submissions.
• Work concurrently on a number of projects across diverse technologies.

Management and Business Development: (50% of time)

• Develop and manage the User Research team:

• Analyze process workflow and implement operational changes.
• Responsible for ensuring the quality and quantity of work produced, staffing requirements, and personnel management for the immediate team.
• Build the research team to meet corporate financial targets.
• Mentor, coach, and train direct reports in applicable tasks, responsibilities, and regulations. Ensure appropriate standards are always met.
• Hold at least monthly one-on-one meeting with direct reports to monitor workload and performance, providing on-going feedback and recommendations for improvement and development.
• Perform regular review of billable hours and utilization for direct reports.
• Complete and deliver performance appraisals, as required.

• Aide the incorporation of user research into current engineering and clinical business procurement by:

• Understanding prior and current client project needs.
• Establishing design principles, in-house materials, and workshops to empower and support the internal team.
• Analyze the client’s position in their organization, product development and market.
• Provide detailed points of view on the viability of new user research opportunities.
• Build roadmaps to help clients prioritize user research projects as they align with business strategy.

• Strategize and drive the growth of the User Research Team and develop user research as a core capability of TE IVD Solutions:

• Develop objectives and key results to use as factors to measure performance and short-term and long-term growth of the User Research division.
• Develop strategies for the expansion of User Research as a business offering, within and outside the United States.

• Support the commercial team:

• Meet with prospective clients and attend trade shows as necessary to develop the business pipeline.
• Generate statement of works and budgets for all user studies.

• Support ongoing client relationships.

Requirements: Master's degree in Health Informatics or related field (or foreign equivalent), plus 1 year of experience in the job offered, or in a related occupation.    

Special Requirements:  Requires 1 year of experience with the following:

• User experience research methodologies in the medical device field, ideally across different types of products.
• Usability experience applying HE75 and IEC 62366 to developing usability protocols that meet FDA guidelines and requirements for medical devices.
• Advanced knowledge of GCP, ICH and FDA regulatory requirements.
• Hands-on experience with medical device regulatory submissions and different aspects of the medical device product development and clinical trial life cycle.
• Leading project operational teams through all stages of usability studies (forecasting/planning, start-up, conduct, close-out).
• Skills in ideation, concept visualization and form development.

• Hands-on ability in design, fabrication, testing and refinement of user interfaces and functional prototypes.

Required certification:

• Good Clinical Practice (GCP)

May require employment and background checks.

Please apply at www.jobpostingtoday.com, enter job code 20633 and submit resume.