Senior Mechanical Engineer

Willow Laboratories; Irvine (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

Willow Laboratories seeks a Mechanical Engineer to advance noninvasive patient monitoring devices with a focus on design for production and high-volume sensor development.

You will collaborate with engineers and manufacturing teams to bring concepts to production, mentoring junior staff and ensuring project milestones are met in a fast-paced environment.

Qualifications

• MS or BS in a related discipline.
• Design for production experience.
• High volume manufacturing experience.
• Plastic, metal, and laminate parts design experience.
• Biomedical materials experience.
• Experience with documentation systems.
• Product packaging experience.
• Ability to Mentor.
• Excellent conceptual, analytical, and problem-solving ability.
• Excellent communication skills, both verbal and written.
• Experience taking a major device from inception to shipment.
• Knowledge of R&D processes.
• Experience working in both large structured and small entrepreneurial organizations.
• Experience in the medical device industry, preferably physiological monitoring.
• Experience leading projects to completion.

Responsibilities

• Plans and directs new product development, leads design team activity and improves existing processes.
• Work with limited supervision and contribute to project planning.
• Communicate directions clearly and promote best practices in design.
• Directs testing of new products and develops technical protocols and reports.
• Advanced understanding of statistical analysis as it relates to data and testing.
• Develop high volume disposable and reusable sensors from concept to product.
• Interface with peers and management to align design with regulatory and production needs.
• Generate complete engineering drawings and design output documentation.
• Develop systems and processes for high volume sensor production.
• Design and implement automated processes.

Skills

Design for production

High-volume manufacturing

Biomedical materials

Documentation systems

Product packaging

Mentoring

Communication

Problem solving

Inception to shipment

R&D processes

Project leadership

Medical device knowledge

Regulatory awareness

FDA 510(k)

ISO standards

GMP

Organizational experience

Physiological monitoring

Education

BS or MS in related discipline

Job description

This position will be an integral part of our medical technology company that develops and manufactures innovative noninvasive patient monitoring technologies. This position works with a team of engineers on the continuous development of handheld medical devices. The Mechanical Engineer will provide design expertise and integration in the area of Mechanical Engineering development of new products and accessories in the field of non-invasive monitoring technologies.

Duties & Responsibilities:

• Plans and directs new product development, performs both processes and product development activities, leads design team activity to modify plans as appropriate if problems arise, and improves/supports existing processes.
• Must work with limited supervision and will be involved in and have input to project planning.
• Proficient in clearly communicating directions and in influencing people in adopting the best solutions, tools, working practices and promotes cooperation in defining an excellent technical product.
• Directs and facilitates the testing of new products to verify product reliability. Leads the development of technical protocols and reports.
• Advanced understanding of statistical analysis principles as they relate to data analysis and testing reports.
• Developing high volume disposable sensors as well as reusable sensors for noninvasive patient monitors (from concept to product).
• Interfacing with technical peers and senior level managers to maintain mutual understanding of product design needs, regulatory, and production requirements.
• Generation of complete engineering drawings and documentation of all design output.
• Developing systems and processes for high volume disposable sensor production.
• Designing and implementing automated processes.

Minimum Qualifications and Experience:

• MS or BS in a related discipline
• Design Experience (the ability to design for production).
• Manufacturing Experience (High volume).
• Plastic, metal, and woven or laminate parts design experience.
• Biomedical materials (e.g., plastics, adhesives).
• Experience in setup and control of documentation systems.
• Product Packaging experience.
• Ability to Mentor.
• Excellent conceptual, analytical, and problem-solving ability.
• Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering and manufacturing personnel.
• Experience in taking a major device from inception to customer shipment.
• Knowledge and practice of Research and Development Processes.
• Experience working in both large structured and small entrepreneurial organizations.
• Experience in the medical device industry, preferably in physiological monitoring.
• Experience in leading project to completion.

Preferred Qualifications:

• Three or more years of experience in Medical Device, Military, Aerospace or other rigid quality systems, multi-platform environment.
• Prior Medical device manufacturing experience, with working knowledge of:
• FDA 510(k) approval process
• ISO standards
• GMP regulations
• Experience working in both large structured and small entrepreneurial organizations.

Physical requirements/Work Environment:

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary; therefore the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

*Salary is based off of education and experience.