Senior Manager, Hardware/Software Product Development

Position Summary

This leadership position is responsible to lead new product development aligned  with the Vascular Marketing team in the development and sustainability of Hardware/Software systems used in conjunction with Vascular Access product lines.  Responsibilities include 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 navigation technology development, including personnel (internal and external) and activities associated with requirements planning and product development of medical devices, electronics, software and hardware, in accordance with medical device and regulatory standards.  This position is responsible to assure compliance with all quality system requirements, as well as the company’s Design Control and Product Development processes.

Principal Responsibilities

•    Oversee, as Engineering lead, all aspects of new product development from concept through commercialization, including the use of appropriate tools and testing approaches to build and maintain highly reliable and effective navigation systems.
•    Lead and contribute on developing product requirements, 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.
•    Manage system infrastructure required to effectively manage requirements through testing for complex products.
•    Gains a thorough understanding of end user needs, both existing and potential, and uses that knowledge to help design infrastructure that exceeds expectations
•    Presents complex design concepts and rationale to multidisciplinary teams, as well as to key stakeholders and business partners
•    Contributes to and makes recommendations for strategic plans in support of key objectives in a timely and fiscally responsible manner
•    Supports and nurtures strategic vendor relationships; recommends 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, Quality Engineering, Regulatory, outside resources and Manufacturing around development and business objectives.
•    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 process development to understand customer preferences and business requirements, to establish design criteria and improvement recommendations.
•    Implement engineering best practices and best technologies to meet the design requirements and build the applications.
•    Provides guidance on configuration, debugging, and support for infrastructure
•    Receives and prioritizes escalations and incoming requests from product teams and stakeholders
•    Removes roadblocks and obstacles that may impair the Hardware/Software team’s ability to help ensure efforts meet strategic, financial, and technical goals
•    Monitors tools and proactively helps teams struggling with systems issues
•    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
•    Fosters collaboration with team members to drive value and identify and resolve impediments
•    Advocates for the end user and stakeholder by becoming associated with the product, empathizing with and understanding user needs
•    Guides more junior team members in strategy, alignment, analysis, and execution tasks
•    Represent Teleflex R&D at hospitals scientific sessions and seminars to meet with medical personnel, understand trends and competition, and unmet customer needs.
•     Comply with Teleflex’s code of Ethics, the company’s Quality system, and all company policies, rules and housekeeping standards.

 

Education / Experience Requirements

•    More than 10 years of hands-on experience in clinical product design.
•    MSEE, MSME, or MS Biomedical Engineering or equivalent with substantial design experience.
 

Specialized Skills / Other Requirements

•    Designed, released, and shipped multiple successful products.
•    Proved experience with hardware design and testing, firmware, software, and algorithmics.
•    Experience with LabView, Matlab, and .NET framework.
•    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.
•    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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