Sr. R&D Engineer

Job Overview

This position is responsible for aspects of the product design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. The engineering manager plans, organizes and directs engineering staff to meet company objectives for design, new product development and improvement of existing product lines by performing the following duties personally or through subordinates. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

About the Role

The engineering manager will lead the team in designing and developing innovative medical devices that meet customer needs. They will also be responsible for ensuring compliance with FDA QSR (21 CFR 820), ISO 13485 requirements, and adherence to the Quality Management System (QMS).

Responsibilities

• Lead the design and development of innovative medical devices that meet customer needs.
• Ensure compliance with FDA QSR (21 CFR 820), ISO 13485 requirements, and adherence to the Quality Management System (QMS).
• Plan, organize, and direct engineering staff to meet company objectives for design, new product development, and improvement of existing product lines.
• Collaborate with cross-functional teams to ensure successful product launches and continuous improvement.

Requirements

• Bachelor's degree in Engineering or related field.
• Minimum of 5 years of experience in medical device engineering or related field.
• Experience with FDA QSR (21 CFR 820), ISO 13485 requirements, and Quality Management System (QMS).
• Strong leadership and team management skills.
• Excellent communication and problem-solving abilities.

Qualifications

• Proven track record of successfully managing projects from concept to launch.
• Experience with medical device design and development processes.
• Knowledge of medical device regulations and standards.
• Ability to work independently and as part of a team.

Skills

• Strong technical skills in medical device engineering.
• Excellent problem-solving and critical thinking skills.
• Effective communication and interpersonal skills.
• Ability to manage multiple projects simultaneously.

Benefits

Competitive compensation package, including base salary, performance-based bonuses, and equity options. Comprehensive benefits package includes health insurance, retirement plans, and paid time off.

Pay

Salary range: $80,000 - $120,000 annually.

Schedule

Full-time position with flexible working hours to accommodate the needs of the role and the team.