Medical Device Engineer
As part of the Devices, Artwork & Packaging (DAP) organization, this position will focus on providing support to the Device program Leads for the design, development, and industrialization of drug delivery systems from the first new product introduction (NPI) to lifecycle management (LCM) and continuous maintenance.
The Responsibilities
- Contribute to technical activities and ensure the appropriate development, industrialization, lifecycle management, and maintenance of drug delivery systems.
- Collaborate with the program team members, internal stakeholders and external partners,
- Ensure project management of these technical activities performed internally or by external partners,
- Ensure compliance with the medical device Quality Management System,
- Ensure that all intellectual property arising in the course of programs is appropriately protected.
- The Medical Device Engineer Scope may include the following activities:
- Act as a focused contributor to additional device programs.
- Contribute to the evaluation of new devices and technologies to supplement existing platforms or to propose new programs. Preparation of conceptual design and proposal of new programs, including translation of internal customer requirements into realistic product and program requirements.
- Provide support in preparation and justification of design verification, design validation, process validation, commercial launch planning, and contribution to respective regulatory submissions.
- Contribute to creation and maintenance of the Design History File during the whole life cycle management. The Device Program Lead (DPL) is accountable for device documentation ownership as mentioned in the Deliverables Matrix template (sop-af-106068). The DPL authoring responsibility can be transferred to a Medical Device Engineer.
- Life cycle management and maintenance of device programs: o Coordination of the technical activities supporting on-market and life cycle management of medical devices. o Project management of technical medical device activities in relation to market feedback, lifecycle management and maintenance of technical quality and documentation with both internal and external partners. o Preparation, justification, and strategic planning of life cycle management opportunities including for secondary regulatory submissions and post-market approval obligations.
Skills and Knowledge Requirements
- 3+ years of experience in the pharmaceutical/biologics/device industry. Operational GMP or quality experience would be a distinct advantage.
- Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements.
- Green Belt and/or Project Management certification will be a distinct advantage.
- Contribute to a program team to achieve a desired objective or outcome especially when working in a cross-cultural team environment. Also needs to be able to share technical competencies through coaching/training team members when appropriate.
- Influencing cross-functional and matrix teams.
- Negotiation skills and ability to influence.
- Must be able to effectively interact with internal and external personnel on many aspects of project and product related matters. Be confident in providing constructive feedback (and accepting feedback) from work colleagues.
- Able to cope with stressful situations and drive issue resolution and decisions.
- Excellent planning and organizational skills.
- Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental and external meetings. Ensure free flow of information throughout the sphere of work.
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
