Senior Project Manager

Job Description

The Diagnostic Cardiology group in Edinburgh are responsible to deliver new products, and updates to existing products, across a portfolio of electronic medical devices, application software and associated accessories.
The position will provide a significant challenge for the successful applicant who will be expected to drive new product development programmes from initial concept generation through to a successful conclusion: on time and in budget. They will be expected to become expert in the definition and use of the product(s), and the technologies that are used.

Role Overview Senior Project Manager- Medical Devices
This position leads project teams, and is responsible for enforcing best practices within the teams, ensuring adherence to company policies, procedures, and compliance requirements; while mentoring and growing the skill set of the team.

Responsibilities:
Project management of a global cross functional team within a regulated medical device quality process
Lead projects throughout the product lifecycle from concept, development, introduction to manufacture and ongoing maintenance.
Develop requirements, specifications, schedules, risk analysis, and tradeoff analysis for products.
Negotiate schedule, risk, product features and resource trade-offs with project and program teams.
Ensure all work product from the team meets Spacelabs processes, QMS requirements and follows best engineering practice, leading by example
Ensure contract resources are effectively managed and deliver services and products as promised, and that meet our QMS requirements.
Generation of detailed project planning and process documentation
Provide frequent communications and formal project reviews with senior management, program team and others as required.

Qualifications:

Experience in related industry and positions –capital equipment, medical device, or other regulated industry.
Experience within a technical engineering role with a strong background in at least one of: electronic devices, embedded software, or application software
Proven years direct project management experience
Proven record of successful project management within an ISO13485 or similar quality system
Proven ability to deliver results through others, both direct and matrixed. Proven ability to build/lead dedicated, passionate teams. Can develop, motivate, and hold others accountable.
Excellent communication and negotiation skills with all levels inside and outside the organization
Robust character and determination to hit goals
A proactive personality is essential along with a very high degree of self-motivation
An eye for detail
The ability to foresee potential problems and effectively mitigate them
Experienced with Microsoft Project software.
Advanced Microsoft Office user - PowerPoint, Excel, and Word.
Experience of project management of a medium to large project within a multinational company
Will be required to travel to the United States and other locations internationally and must be able to acquire all necessary travel documents
Must be able to complete job responsibilities working with global time zone needs such as attending late night/early morning meetings by phone and/or web to meet global business needs: 5%
Desirable
Medical product standards such as the IEC 60601 family
ISO14971 risk management process
FDA QSR Requirements
Participation in Notified Body audits or technical file review

OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.