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Design Control and Document Specialist

4 months ago

Stony Brook, United States ZBEATS INC Full time

**Job Summary**:
**Key Responsibilities**:
Document Creation and Management:

- Develop and maintain comprehensive documentation for the design history file, including design plans, risk management files, verification and validation plans, test protocols, and reports.
- Ensure that all documentation meets regulatory standards and guidelines (e.g., FDA, ISO 13485, IEC 62304).

Design Control:

- Implement and manage design control processes, ensuring that design activities are properly planned, controlled, and documented.
- Facilitate design reviews and ensure that all design changes are documented and justified.

Regulatory Support:

- Collaborate with the VP of RA/QA to ensure all regulatory submissions are accurate and complete.
- Stay up-to-date with relevant regulatory requirements and ensure that the development team is aware of and compliant with these requirements.

Training and Guidance:

- Provide training to the development team on documentation requirements and best practices.
- Serve as a resource for the development team, providing guidance on regulatory and documentation issues.

Continuous Improvement:

- Identify opportunities for improving documentation processes and implement best practices.

Ensure that all documentation processes are efficient and scalable to support future product development.

**Education**:

- Bachelor’s degree in Biomedical Engineering, Regulatory Affairs, or a related field. Advanced degree preferred.

**Experience**:

- Minimum of 5 years of experience in medical device development, with a strong emphasis on documentation and design control.
- Experience with software as a medical device (SaMD) and hardware components is highly desirable.
- Familiarity with FDA regulations, ISO 13485, IEC 62304, and other relevant standards.

**Skills**:

- Strong understanding of design control and documentation processes for medical devices.
- Excellent written and verbal communication skills.
- Ability to work collaboratively with cross-functional teams.
- Detail-oriented with strong organizational skills.

**Competencies**:

- Ability to thrive in a fast-paced, dynamic start-up environment.
- Ability to manage multiple projects and prioritize tasks effectively.
- Strong problem-solving skills and the ability to think critically.
- Ability to work independently and as part of a team.

**Working Conditions**:

- The role involves working in an office environment with standard office equipment.
- This position may require occasional travel.

**Benefits**:

- Competitive salary and comprehensive benefits package.
- Professional growth and development opportunities.
- Collaborative and innovative work environment.

**Application Process**:
**About Zbeats**: Zbeats is committed to advancing healthcare through innovative medical devices. We offer a supportive environment where you can grow your career, work on meaningful projects, and be part of a team dedicated to improving patient outcomes

**Equal Opportunity**: Zbeats is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

**Job Types**: Full-time, Part-time

Pay: $30.00 - $50.00 per hour

Expected hours: 20 - 45 per week

**Benefits**:

- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Vision insurance

**Experience**:

- medical device development: 5 years (required)

Ability to Commute:

- Stony Brook, NY 11794 (preferred)

Ability to Relocate:

- Stony Brook, NY 11794: Relocate before starting work (preferred)

Work Location: Hybrid remote in Stony Brook, NY 11794