The Engineering Manager Hardware is responsible for establishing and leading a high-performing team focused on Product Lifecycle Management (PLM) of parts and key sub-systems in Medical Devices through external R&D partnerships. You will play a pivotal role in shaping how we collaborate with specialized engineering partners to support Radiometer s product portfolio.

This position initially reports to Senior R&D Manager in Copenhagen, Denmark and in dotted line to the BDC site-lead . The position is part of the Global Instrument R&D and the position is located in BDC office, Bangalore, India. It will be an on-site role.

In this role, you will have the opportunity to:

Build and lead a dedicated on-site team in Bangalore to manage hardware sustaining activities through external partnerships
Establish, maintain and continuously improve strategic partnerships with external R&D partners
Define and continuously improve processes for efficient lifecycle management of parts and sub-systems. And you will be key to ensure seamless collaboration across internal functions including design engineering, software, service, manufacturing, sourcing, and quality.

Within parts and sub-systems in scope, the role will have oversight and accountability for

Negotiate and maintain partnerships w. key external providers
Establish and continuously improve process to foster efficient product lifecycle management with the involvement of external R&D partners
Lead local team and facilitate collaboration with key global stakeholders
Budget for hardware sustaining engineering
Managing component obsolescence in coordination w. sourcing
Maintaining product quality and reliability
Driving cost reductions
Documentation and change control incl. transfer to manufacturing
Interface to service for field actions and spare parts planning

The essential requirements of the job include:

A master s/bachelor s degree in Mechanical/Electronics Engineering, potentially combined with Business, Project management. HW design and development experience.
Experience working in and handling design documentation in a regulated industry (eg Medical Devices)
5+ years of experience from external partnerships and working with cross-functional project management preferably within healthcare or other regulated industries.
2+ experience of developing and leading a high-performance team with solid engagement in global environment. Having flexibility and the ability to work independently and in teams, taking responsibility for our own tasks and team.
Experience with making contracts in collaboration with stakeholders like Global R&D, legal [local and Global], Supply chain and other relevant stakeholders.
Strong analytical, structured, and process-oriented mindset
Excellent interpersonal skills and stakeholder management abilities as well as effective communication and presentation skills.

Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role

Ability to travel some travels to partner as well as other Radiometer sites incl HQ in Copenhagen, Denmark.

It would be a plus if you also possess previous experience in:

Experience with and understanding of applicable design control documentation, eg. in accordance FDA 21CFR 820.30, ISO 13485 and other applicable standards.
Proven track record of project and portfolio management and Ms in Electronics for Mechanics.
Experience from a multi-cultural global company setup

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Engineering Manager - Hardware