Senior Expert Engineering

Biopharma Careers; Basel; Vor Ort; CHF 94.000 - 174.000; Vollzeit

Benefits dieser Stelle

Hybrid working options

Parental leave

Insurance plans

Retirement plans

Zusammenfassung

Novartis’ Device Technology Solution Center seeks a Senior Expert Engineering to lead the development of innovative drug‑device combination products, including autoinjectors and on‑body injectors. You will collaborate with project management, human factors engineering, packaging, analytical testing, quality, production, and regulatory teams.

The role focuses on delivering DHF/Design Control documentation, guiding verification, ensuring regulatory compliance, working with suppliers and CMOs, and

Qualifikationen

• Degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Typically 10+ years in medical device or combination product development.
• Excellent verbal communication and English writing skills.
• Ability to influence cross-functional teams in a matrix environment.
• Experience with design verification and DHF documentation.
• Knowledge of medical device regulations and industry standards.
• Experience with suppliers and CMOs.
• 80% on-site work (4 days/week).

Aufgaben

• Provide technical leadership in cross-functional device development subteams for autoinjector and other drug-device combination product development projects.
• Define design input requirements and specifications; author, review, and approve Design History File (DHF) documentation.
• Lead design verification and characterization activities to demonstrate compliance with applicable requirements, standards, and intended use.
• Provide technical input to regulatory submission dossiers and support responses to health authority questions related to device design, performance, and verification activities.
• Perform technical investigations and root cause analyses, identify corrective actions, and implement robust technical solutions to prevent recurrence of product and process issues.
• Ensure development activities comply with applicable regulations, standards, and internal procedures.
• Collaborate with external partners, suppliers, contract manufacturers, and internal manufacturing organizations to ensure successful device development and industrialization.
• Ensure documentation and materials are delivered to support clinical studies, registration, and commercial manufacturing.
• Provide scientific and technical guidance to team members, facilitate knowledge sharing, and contribute to the development of engineering best practices.

Kenntnisse

Technical leadership

Cross-functional collaboration

DHF documentation

Design verification

Regulatory knowledge

Root cause analysis

Supplier/CMO experience

English communication

Ausbildung

Bachelor's degree in Mechanical or Biomedical Engineering

Jobbeschreibung

Location

Location: Basel, Switzerland #onsite

Role Purpose

At Novartis, we are reimagining medicine to improve and extend people's lives. We discover and develop breakthrough treatments and find new ways to bring cures to as many people as possible. Without safe, easy-to-use, high-quality drug delivery devices, our patients could not get their medicines. This is where you come in - the Device Technology Solution Center is looking for a Senior Expert Engineering to lead the development of innovative drug-device combination products. We from the Device Technology Solution Center drives the technical development of autoinjectors as well as novel drug delivery principles, e.g. on-body injectors, inhalers or radioligand therapy. We closely collaborate with project management, human factors engineers, packaging experts, analytical testing, quality assurance, production, external partners, regulatory experts and many more. The objective is to develop and/or integrate innovative drug delivery systems with drug formulation and author state-of-the-art technical documentation for health authorities and production.

Your responsibilities include, but are not limited to:

• Provide technical leadership in cross-functional device development subteams for autoinjector and other drug-device combination product development projects
• Define design input requirements and specifications, and author, review, and approve Design History File (DHF) documentation
• Lead design verification and characterization activities to demonstrate compliance with applicable requirements, standards, and intended use
• Provide technical input to regulatory submission dossiers and support responses to health authority questions related to device design, performance, and verification activities
• Perform technical investigations and root cause analyses, identify corrective actions, and implement robust technical solutions to prevent recurrence of product and process issues
• Ensure development activities comply with applicable regulations, standards, and internal procedures
• Collaborate with external partners, suppliers, contract manufacturers, and internal manufacturing organizations to ensure successful device development and industrialization
• Ensure documentation and materials are delivered to support clinical studies, registration, and commercial manufacturing
• Provide scientific and technical guidance to team members, facilitate knowledge sharing, and contribute to the development of engineering best practices

Role Requirements

• Degree in Mechanical Engineering, Biomedical Engineering, or a related discipline
• Significant experience (typically 10+ years) in medical device and/or combination product development
• Excellent verbal communication and technical writing skills in English are required
• Demonstrated ability to influence cross-functional teams and lead technical initiatives in a matrix environment.
• Experience in design verification
• Good knowledge of applicable medical device regulations and industry standards
• Experience working with suppliers and CMOs
• Experience with Design Controls and Design History File (DHF) documentation
• Minimum 80% on site work (4 days/week)
• Commitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Benefits & Rewards

• At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
• Expected Annual Base Salary Range for role: CHF 93,800 to CHF174,200
• The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
• In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
• The rewards of being part of our team go far beyond base pay and incentives.
• We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
• In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.