Job Title:
Principal Engineer for Device and Combination Product Development
">
* Develop and execute a strategic roadmap for the development of biologic-device combination products, aligning with company objectives.
* Lead human factors development activities to ensure usability and patient safety. Primary stakeholder for human factors evaluation of drug delivery combination product development.
* Author and review human factors/usability engineering plans, risk management documentation, study protocols and reports, and supportive design control documentation.
* Collaborate with cross-functional teams to ensure successful project delivery.
* Provide technical leadership and expertise in drug delivery technologies, device design, design control, and manufacturing processes.
* Manage and prioritize multiple projects simultaneously, ensuring adherence to timelines and budgets.
* Manage vendor relationships and contracts for outsourced development and manufacturing activities.
* Ensure compliance with relevant regulatory requirements throughout the product lifecycle.
* Lead the implementation and management of design control processes and facilitate maintenance of the design history file.
* Support packaging development for combination products.
* Demonstrate expertise in prefilled syringe and autoinjector product development.
* Author relevant sections for regulatory submissions.
* Build and maintain strong relationships with key stakeholders.
* Support design transfer activities.
">
Qualifications and Requirements:
A bachelor's degree in biomedical engineering, mechanical engineering, pharmaceutical sciences, or related field is required. Advanced degree preferred.
No less than 8 years of experience in drug product device development with a proven track record of successful product launches.
Background in leading human factors formative and summative evaluations.
Demonstrated knowledge of regulatory requirements and industry best practices.
Extensive experience with the development and commercialization of prefilled syringes and autoinjectors.
Proven experience in implementing and managing design control processes.
Deep understanding of subcutaneous drug delivery systems, systems engineering, materials, and manufacturing processes.
Knowledge of current FDA and EU medical device regulations and quality systems.
Proven experience in vendor management and contract negotiation.
Excellent communication and interpersonal skills in working across the organization.
Ability to operate in an agile, fast-paced environment.
Alignment with company core values.
Benefits:
Eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
Comprehensive benefits package including medical, dental, and vision insurance.
401k match and flexible time off.
Number of paid holidays.