Systems Engineer

MedTech / Medical Devices / SF Bay

Representing a pioneering medical device company that specializes in the development of unique life-saving Medical Technologies.

They are currently seeking an experienced Systems Engineer to join their dynamic team. The successful candidate will have a robust background in the medical device industry, with specific experience in developing requirements and executing testing.

Key responsibilities:

• Developing system requirements and overseeing design control functions.
• Executing system testing and managing design verification and validation functions.
• Collaborating with cross-functional teams to ensure system design meets project objectives and regulatory standards.
• Identifying potential system issues, troubleshooting problems, and implementing effective solutions.

Qualifications:

• Bachelor's Degree in Biomedical, Systems, or equivalent.
• 3-6 years of industry experience in the development of medical devices.
• Experienced troubleshooting, testing, designing fixtures, etc.

Mechanical Engineer - Electromechanical Engineer

MedTech / Medical Devices / SF Bay

Representing a pioneering medical device company that specializes in the development of unique life-saving Medical Technologies.

They are currently seeking a talented and experienced Mechanical Engineer to join the team. The successful candidate will have a hands-on technical background in developing medical devices.

Key responsibilities:

• Participating in all stages of product development from concept through design, development, testing, and regulatory approval.
• Collaborating with cross-functional teams to meet project objectives and deadlines.
• Ensuring compliance with all regulatory standards throughout the product lifecycle.
• Utilizing problem-solving skills to troubleshoot design and process challenges.
• Contributing to continuous improvement initiatives to enhance product quality and performance.

Qualifications:

• Bachelor's degree in mechanical engineering or related field.
• 4-6 years of industry experience in the development of medical devices
• Experience with electromechanics preferred.

Project Manager

MedTech / Medical Devices / SF Bay

Representing a pioneering medical device company that specializes in the development of unique life-saving Medical Technologies.

They are currently seeking an experienced Project Manager to join their dynamic team. The successful candidate will have a robust background in the medical device industry, with specific experience in managing the development of medical devices from concept to completion.

Key responsibilities:

• Overseeing projects from initiation to completion, ensuring they are completed on time, and within scope and budget.
• Coordinating cross-functional teams, including engineering, production, quality, and regulatory affairs.
• Establishing and maintaining processes for managing project scope throughout the lifecycle, setting performance standards, and assessing risks.
• Ensuring compliance with all regulatory standards throughout the product lifecycle.
• Communicating effectively with all stakeholders to ensure alignment and meet project objectives.

Qualifications:

• Bachelor's degree in engineering, or related field.
• 8+ years of industry experience in coordinating the development of medical devices.
• Knowledge of FDA and ISO regulations for medical devices.