Principal Engineer, DDS Devices

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
R&D Product Development

Job Sub Function:
Biomedical Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Schaffhausen, Switzerland

Job Description:

Description

The candidate will work at the interface between product development and assembly process development.

The candidate will provide technical direction and leadership in exploration, evaluation and development of (critical) process parameters from early stage product development to commercial launch of combination products.

The candidate will also serve as a single point of contact to coordinate the combination product control strategy of multiple products  with ability to work across multiple Drug Products and Manufacturing Sites.

The candidate will also support the strategic direction of developing the assembly strategy, including technology transfer and Critical Process Parameter alignment across multiple assembly equipment and manufacturing sites.

Specific responsibilities of the Principal Engineer of R&D includes but not limited to:


* Guide project team activities to meet project and business with specific focus on assembly process development and development of the control strategy


* Drive team accountability for process improvement and implementation, helping to communicate the importance of process development throughout the organization.


* Demonstrate business acumen, project management, communication, process management and team performance management; ask the right questions to understand business impact and risks


* Make the complex simple and represent a true enterprise view when communicating opportunities and plans to the team and organization


* Lead team through options analysis and drive multi-functional recommendations


* Evaluate different assembly technologies with a multitude of device and primary container platforms.


* Use scientific and engineering judgement, generate data where needed.

Coordinate the assembly process development within the framework set by the Quality Management System and the Regulations and align dates and expectations with key stakeholders. 


* Understand technological advancements, environmental changes, key competitor’s offerings; and provide analysis on technological feasibility, I/P landscape, risk assessment, and sales and market considerations


* Strong knowledge of FDA Design Controls/ISO13485 and medical device product...