Research And Development Manager

Asia Pacific Medical Technology Development Company Limited

Vue: 154

Jour de mise à jour: 05-11-2024

Localisation: Taipei City Neihu District

Catégorie: Autre

Industrie:

Type d’emploi: Full-time

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le contenu du travail

Summary:

The R&D Manager is responsible for overseeing the technical and programmatic aspects (technical design, schedule, resources, scope and design control) of the cardiopulmonary product lines. The technical groups, with several R&D Managers, Development Engineers and contractors located in the USA and the Asia Pacific regions, are engaged in two major product development projects as well as some sustaining engineering activities. The R&D Manager’s duty is to build a small team of product development engineers in Taipei to implement appropriate product development processes and disciplines across the groups, and to measure actual schedule, budget and product delivery performance by both in-house and outsourced engineering and manufacturing staff.

As Deputy to the CTO of R&D, the R&D Manager complements the duty of other R&D Managers or Senior Engineering staffs whose primary focus is on technical innovation and optimization of engineering solutions for cardiopulmonary applications. The product family includes a line of electromechanical blood pumps, heat exchangers, oxygenators, and one-time use catheters.

The ideal candidate will be a hands-on engineering manager with deep engineering knowledge and people management techniques and demonstrated track record as a practitioner. The candidate should be familiar with the product development environment and processes. Previous experience in medical devices or other regulated industries is a plus, but not absolutely required. The company will provide training in the medical device quality regulations for highly motivated and versatile individuals.

Job functions:

  • Participate in engineering design and transfer to manufacturing of key products which are of significant strategic importance to the corporation.
  • Build up a small engineering team in Taipei. Supervise members of R&D staff inside and outside Taipei where appropriate.
  • Manage the supply chain of outsourced subsystems including electromechanical subsystems, PCB and one-time use catheters.
  • Develops and maintains detailed project schedules and budgets for assigned projects. Drives the tactical project execution. Routinely reports on the status of the project relative to the schedule and budgets.
  • Ensures compliance with ISO 13485 Quality Management and Taiwan FDA Good Manufacturing Practice (GMP).
  • Participate in clinical and customer preference testing, including the validation of performance and reliability test data. Interface with cardiopulmonary surgeons and specialists to obtain feedback and product improvement ideas. Prioritize and schedule resources to implement selected clinical features.
  • Responsibilities:

    1. With about 3-5 direct reports in Taipei, but will, on a specific project basis, direct efforts of engineers, technicians, designers and outsourced contractors outside Taipei. The ability to organize, lead and motivate people toward the achievement of a common goal is a primary requirement for the position.

    Deals with all members of product development team internally and with the medical community as well as vendors and consultants externally.

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    Date limite: 20-12-2024

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