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RORoche

last mo.

Medical Device Platform Technical Lead(m/w/x)

Basel

Full-timeOn-siteSenior

Nejo AI Summary

Leading technical teams for autoinjector and PFS-needle safety device platforms. Systems engineering fundamentals and mechanical product design expertise required. Personal expression encouraged, fostering genuine connections.

Requirements

Expertise in systems engineering fundamentals
Mechanical product and process design
Collaborative operation in cross-functional teams
Systems-level perspective
Integration of device constituents and container closure systems
Compliance with regulatory and quality standards
Delivery of safe, effective, scalable drug delivery devices
BS in Mechanical Engineering or equivalent technical degree
In-depth understanding of prefilled syringes
In-depth understanding of Autoinjector
In-depth understanding of PFS-Needle Safety Device
In-depth understanding of novel drug delivery design and manufacturing
Technical expertise in device development
Technical expertise in integrated combination product development
Comprehensive understanding of pharmaceutical processes
Comprehensive understanding of delivery system processes
Knowledge of Medical Device regulations
Experience with Requirement Management
Experience with Requirement Hierarchies
Experience with Requirement Traceability
Experience with Requirement Authorship
Experience with Platform vs Variant modalities
Experience with systems engineering fundamentals
Experience with continuous improvement methods and toolsets
Excellent communication skills
Excellent interpersonal skills
Excellent collaboration skills
Ability to engage with cross-functional teams
Ability to engage with external suppliers
Ability to engage with industry partners
Ability to influence across scientific disciplines
Ability to influence across organizational boundaries
Entrepreneurial spirit
Hands-on, roll-up-your-sleeves approach
High sense of urgency
Dedication to drive for results

Tasks

Lead technical teams in developing Autoinjector and/or PFS-Needle Safety Device platforms
Maintain Autoinjector and/or PFS-Needle Safety Device platforms
Lead cross-functional technical teams for drug delivery platforms
Develop and maintain robust drug delivery platforms
Drive design excellence across diverse device platform technologies
Lead Platform Technology teams in creating the Platform Design History File (DHF)
Maintain the Platform Design History File (DHF)
Collaborate with teams to develop Platform DHF elements
Collaborate with teams to maintain Platform DHF elements
Develop required Platform DHF documents
Lead platform initiatives supporting product design and development
Strategically plan platform data leverage plans
Implement platform data leverage plans
Provide platform technical support for E2E project activities
Work with global cross-functional teams on development principles
Broaden understanding of product and platform development principles
Foster relationships with third-party development partners
Provide technical expertise in systems engineering principles
Define user and stakeholder needs
Define requirements
Manage risk for platform devices
Define product architecture for platform devices
Manage configuration for platform devices
Ensure traceability for platform devices
Manage change for platform devices
Ensure reliability for platform devices
Develop phase-appropriate platform-based verification methodologies
Harmonize phase-appropriate platform-based verification methodologies
Streamline phase-appropriate platform-based verification methodologies
Develop phase-appropriate platform-based testing methodologies
Harmonize phase-appropriate platform-based testing methodologies
Streamline phase-appropriate platform-based testing methodologies
Collaborate with regulatory teams on compliance
Prepare technical documentation for regulatory submissions
Review technical documentation for regulatory submissions
Prepare technical documentation for regulatory audits
Review technical documentation for regulatory audits
Manage CDMO relationships for platform focused design
Manage CDMO relationships for device platforms

Work Experience

10 years

Education

Vocational certificationOR
Bachelor's degree

Languages

English – Business Fluent

Tools & Technologies

Requirement Management
Requirement Hierarchies
Requirement Traceability
Requirement Authorship
Platform vs Variant modalities
systems engineering fundamentals
continuous improvement methods
continuous improvement toolsets

Benefits

Informal Culture

Personal expression encouraged
Open dialogue encouraged
Genuine connections fostered
Valued, accepted, and respected
Creativity fostered

Mentorship & Coaching

Personal and professional thriving

Purpose-Driven Work

Empowerment to explore possibilities

Other Benefits

High ambitions supported

Healthcare & Fitness

Life-changing healthcare solutions delivery

Social Impact

Global impact

Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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RORoche

last mo.