Senior Scientist - Design Control (Hybrid)
About The Position
The Senior Scientist, Device Design Control Lead, is responsible for leading device design control efforts in combination product development, commercialization, and lifecycle management. The role oversees device design control activities to support high-quality products and efficient manufacturing processes. The position collaborates with subject-matter experts across cross-functional combination product development teams throughout the product lifecycle, from concept through launch and post-market surveillance. It also contributes to the development and ongoing improvement of device design control processes, procedures, and tools, and to the strategic development of the Device Design Control function.
Requirements
- Bachelor’s or master’s degree in Engineering, Science, or a related field.
- At least 6 years of related experience in pharmaceutical development, device development, device systems operations, quality management, or a related area.
- Strong knowledge of regulatory requirements and industry standards related to device systems.
- Strong analytical and statistical skills, including experience with data interpretation and risk assessment tools.
- Excellent communication, leadership, and problem-solving skills.
- Ability to work in a dynamic, fast-paced environment and manage multiple priorities effectively.
- Analytical method development.
- Experience with external partners.
- Geometric dimensioning and tolerancing (GD&T).
- ISO 13485 medical devices.
- Manufacturing processes.
- Mechanical design and mechanical testing.
- Method validation.
- Product development and prototyping.
- Statistical analysis, teamwork, and technical writing.
Responsibilities
- Lead and contribute to device development design controls for assigned projects.
- Prepare materials for program presentations for management review and regulatory submissions.
- Lead implementation and/or ensure effective execution of device development strategy and design controls for assigned projects, following management-approved plans and corporate policies.
- Communicate clearly with cross-functional stakeholders, including external suppliers, about project strategies and design controls.
- Proactively resolve project obstacles and challenges and communicate the device development strategy and design control approach within Device Development and to external suppliers.
- Understand and apply regulatory and compliance requirements relevant to design controls and risk management.
- Contribute to developing, implementing, and continuously improving device design control processes, procedures, and tools.
- Participate in strategic development of the Device Design Control function and contribute to team goals and initiatives.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Other insurance benefits for employees and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Senior
