Staff R&D Engineer, Adona Medical

Adona Medical; Los Gatos (CA); On-site; USD 90,000 - 180,000; Full time

Job summary

An innovative medical device company is seeking a Staff R&D Engineer to lead the design of advanced catheter-based devices. This role is pivotal in developing new medical technologies aimed at improving heart failure treatments. The successful candidate will thrive in a dynamic team environment, driving projects from concept to clinical application. If you are passionate about creating impactful medical solutions and possess a strong background in mechanical engineering, this is a fantastic opportunity to make a significant difference in patient care.

Benefits

Medical Insurance

Vision Insurance

401(k)

Disability Insurance

Qualifications

• 7+ years of experience in mechanism and medical device design.
• Proficient in SolidWorks and rapid prototyping.

Responsibilities

• Design and develop delivery systems for cardiac implants.
• Lead the design and development of medical catheters.

Skills

Mechanism Design

Medical Device Design

Solid Modeling

Rapid Prototyping

Project Management

Education

Bachelor of Science in Mechanical Engineering

Master's Degree in Mechanical Engineering

PhD in Mechanical Engineering

Tools

SolidWorks

Test Equipment

Job description

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This range is provided by Adona Medical. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$90,000.00/yr - $180,000.00/yr

Adona Medical, a Shifamed Portfolio Company, is focused on innovating interventional approaches for heart failure, a complex and progressive condition. Heart failure is a progressive condition that impacts approximately 6.5 million patients in the United States and as many as 26 million patients globally. To learn more about Adona Medical, please visit https://www.adonamed.com/.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

This position will play an important technical role in developing new catheter-based medical device designs. The Staff Engineer will be expected to work as a key member of a team that quickly conceptualizes and develops new designs. The Staff Engineer will play a lead role in the design and development of mechanical systems, subsystems and the user interface of disposable medical catheters. They must be capable of creating designs capable of being used in clinical studies and for commercial sales. The successful candidate must excel in a high-energy team environment and be capable of making sound decisions when faced with time pressures and incomplete information typical of new product development. The Staff Engineer must be capable of leading engineers or technicians through the design and development process. This is a full time on-site position and will require reporting to our offices located in Los Gatos, CA.

Responsibilities, Skills & Hands-On Experience

• Primarily responsible for design and development of delivery systems, sub-systems and housings for deployment of a cardiac implant.
• Experience with designing and testing of molded handle housings and complex mechanisms.
• Rapid prototype design, build, test, and iterate concepts under development.
• Support animal model and Sim-Use bench testing.
• Design for cost and manufacturability.
• Project planning and management for aspects of the system under the engineer’s authority.
• Vendor selection and management.
• Supervise technical staff (engineers, technicians and interns).
• Generation of formal design documentation, review, and control (e.g. design reviews, ECOs, mechanical drawings, etc.).
• Manufacturing transition and support.
• Develop and author test methods, protocols and reports used for evaluation of prototypes and product performance.
• Concept documentation, preparation and review of patent submissions, and support for regulatory submissions.
• Perform other duties as assigned.

Preferred Skills & Hands-On Experience

• Research and recommend test equipment and design tools.
• Run machine shop/lab equipment necessary for prototyping.
• Collaborate in the evaluation and assessment of competitive products, processes or new trends.
• Participate in and present at department level meetings and projects.
• Work with the Regulatory Department to ensure that design specifications for the system meet or exceed all applicable environmental and regulatory standards.

Education & Work Experience

• Bachelor of Science in Mechanical Engineering, Biomedical Engineering or Material Science.
• Advance degree preferred, master’s degree in ME, or PhD.
• At least seven (7) years’ experience with mechanism design, including medical device design experience.
• Proficient in solid modeling. SolidWorks required.
• Experience designing molded components and assemblies for use in disposable medical devices.
• Experience with design excellence and rapid product development.
• Passion for creating robust and reliable products.
• Demonstrated history of products reaching the marketplace.
• Experience leading small engineering teams and mentoring other engineers.
• Knowledge of ISO requirements and GMP guidelines. Experience with FDA regulations and medical device design control a strong plus.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $90,000 to $180,000 + equity + benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to [e-mail].

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Medical Device

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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