Director, Hardware & Software Product Development

Position Summary

This leadership position is responsible for leading both new product development and sustaining project efforts for the Hardware/Software program in alignment with the Vascular Marketing team and in conjunction with Vascular Access product lines. Responsibilities include team development and leadership, technical creation, and execution management of a pipeline of new products, aligned to the strategic plan for the overall business. This role also supports the lifecycle management of current navigation technology systems. This role includes the training and development of personnel (internal and external) and activities associated with requirements planning and product development of medical devices, electronics, hardware, software, and systems (SaMD and SiMD), in accordance with medical device including regulatory and international standards. This position is responsible to ensure compliance with all quality system requirements, as well as the company’s Design Control and Product Development processes.

Principal Responsibilities

•    Lead a multi-site team of Mechanical, Electrical, and Software R&D engineers that support the development of the Vascular navigation system. 
•    At a senior leadership level, this role partners with Global Strategic Marketing on Hardware & Software strategic roadmap development and owns the execution of aligned objectives to support the business objectives. 
•    Oversee all aspects of new product development from concept through commercialization, including the use of appropriate tools, standard operating procedures, and testing approaches to build and maintain highly reliable and effective navigation systems including developing a global strategy of next generation products and services for navigation devices. Demonstrate strong technical expertise and ability to mentor others in both hardware and software development of connected devices in the healthcare environment (including cybersecurity concerns).
•    Develop intuitive product design that allows users easier and earlier adoption and use of Human Factors Engineering principles.
•    Demonstrate strong clinical understanding in the utilization of ECG technology for navigation of medical devices in the human circulatory system.
•    Project planning, system design, prototyping, hazards/risk/DFMEA/PFMEA, verification, validation, and design transfer.
•    Utilize resource team to execute system development, including 3rd party resources, with current state of the art development approaches, to efficiently prototype and refine development alternatives.
•    Ability to effectively balance new product development and current portfolio lifecycle management through assessment of risks and priority.
•    Partner with Design assurance to effectively manage requirements through testing for complex products.
•    Contribute to and make recommendations for strategic plans in support of key objectives in a timely and fiscally responsible manner.
•    Support and nurture strategic vendor relationships; recommend ways to influence vendors that align to domain, portfolio, and enterprise strategic objectives.
•    Provide subject matter expertise to the business to continue to refine business processes to meet demands.
•    Partner with Program Management, Marketing, Design Assurance, Regulatory, outside resources and Global Supply Chain around development of business objectives. Drive accountability to project schedules and milestone delivery in accordance with project prioritization and planning.
•    Collaborate with Program Management to plan, execute and technically lead multiple projects using project plans and schedules to track and communicate development activity from concept to commercialization. Interface with clinicians, customers, marketing, and service to understand customer preferences and business requirements, to establish design criteria and improvement recommendations.

 

Education / Experience Requirements

•    Bachelor’s degree with at least 15+ years of experience in medical device hardware & software product development, including a minimum of 10 years of design experience.
•    Minimum of 10+ years of people manager experience.
•    MSEE, MSME, or MS Biomedical Engineering highly preferred.
 

Specialized Skills / Other Requirements

•    Designed, released, and shipped multiple successful medical device products.
•    Proved experience with hardware design and testing, firmware, software and algorithmics.
•    Experience with Agile methodology. 
•    Experience with LabView, Maltab, Jira, Jama and .NET framework.
•    Knowledge of Dicom, Ultrasound and ECG.
•    Experience working within a Design Controls/ISO 13485 system or ISO 9001 or similar quality system, or a willingness to rapidly learn these process requirements.
•    Knowledge of applicable standards and regulations such as IEC 62304, IEC 60601, IEC 62366, and ISO 14971.
•    Familiar with IPC design and development standards that drive to improve reliability. 
•    Reliability engineering knowledge to ensure designs are robust and will perform as intended through various methods of analysis such as HASS and HALT.

•    Implement engineering best practices and best technologies to meet the design requirements and build the applications.
•    Provide guidance on configuration, debugging, and support for infrastructure.
•    Receive and prioritize escalations and incoming requests from product teams and stakeholders through Agile Methodology.
•    Remove roadblocks and obstacles that may impair the Hardware/Software team’s ability to help ensure efforts meet strategic, financial, and technical goals.
•    Serve as a leader, mentor and coach for engineering personnel on clinician interaction, product design and development, verification and validation testing, design history file documentation and business leadership.
•    Foster collaboration with all team members to drive value, develop a strong culture of inclusion, in addition to proactively identify and resolve impediments.
•    Represent Teleflex R&D at hospitals scientific sessions and seminars to meet with medical personnel, understand trends and competition, and unmet customer needs. Show strong communication skills in working with all levels of the organization, including executive level report outs. 
•    Comply with Teleflex’s code of Ethics, the company’s Quality system, and all company policies, rules and housekeeping standards.
•    Be prepared to travel to support any aspects of the development lifecycle from requirements to support ongoing project needs
•    Experience with Intellectual Property/Patents desirable.
•    Strong analytical and problem-solving skills.
•    Effective verbal and written communication skills.
•    Team player with good interpersonal skills.
•    Solid management and mentoring skills for both direct and indirect reports
•    Proficient in Microsoft Office Suite and computerized design applications.

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