Principal R&D Engineer - Implant, Adona Medical

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

Job summary

An innovative medical device company is seeking a Principal R&D Engineer to develop cutting-edge electromechanical implants for heart failure treatment. This role involves hands-on prototyping, cross-functional collaboration, and the opportunity to influence the design of life-saving devices. The ideal candidate will bring extensive experience in implant design and a passion for advancing medical technology. Join a dynamic team at the forefront of healthcare innovation, where your contributions will directly impact patient outcomes and drive the future of medical devices.

Benefits

Medical Insurance

Vision Insurance

401(k)

Disability Insurance

Equity Options

Qualifications

• 12+ years of experience in implantable medical device design.
• Experience in a venture-funded startup environment.

Responsibilities

• Support design and development of implant systems and assembly procedures.
• Prepare technical documentation for regulatory submissions.

Skills

Implant Design

Prototyping

CAD Design (SolidWorks)

Communication Skills

Project Management

Medical Device Regulations

Education

BS in Mechanical Engineering or Biomedical Engineering

Masters Degree

Tools

SolidWorks

Basic Hand Tools

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 a new electromechanical implant used to treat heart failure. The Principal Implant R&D Engineer will work as a key member of a team that quickly conceptualizes and develops new designs, develops and optimizes manufacturing processes, and conducts verification & validation testing. The successful candidate must be capable of applying scientific rigor in analyzing and characterizing new designs, and providing solutions that create a robust device, capable of being used in clinical studies and for commercial sales. We are currently looking for a hands-on engineer who is a creative thinker, problem-solver, collaborative team player and active in their approach to concept generation and execution. This position represents an exciting opportunity to join the Adona team in its early stage and help us advance our flagship product from design freeze into clinical launch. 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 supporting the design and development of implant systems, sub-systems and assembly procedures for the active cardiovascular implant.
• Hands-on prototyping and development of device, processes and tests.
• Work as part of a cross-functional team to develop and evaluate product designs through verification and validation testing.
• Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions.
• Participate in, and present at, periodic department level meetings.
• Contribute to the company’s intellectual property via invention disclosures, brainstorming sessions, and prototypes to demonstrate reduction to practice.
• Mentor and direct other Engineers in product development and design verification testing.
• Experience in implant design, materials and processing; preferably used in structural heart or cardiovascular applications.
• Hands-on prototype manufacturing.
• Proficient in CAD design and documentation software; SolidWorks preferred.
• Basic hand tool operation.
• Excellent communication skills; ability to work both independently and in project team setting.
• Knowledgeable about medical device regulations, ISO requirements and GMP guidelines.
• Design verification testing.
• Project planning and management.
• Experience leading small engineering teams and mentoring other engineers.
• Experience working in a lab and CER.

Preferred Skills & Hands-On Experience

• Experience with Nitinol preferred.
• Experience with implantable coatings, membranes and/or fabric technologies preferred.
• Experience in designing and making test and process fixtures and equipment.
• Basic machine shop skills.
• Vendor selection and management.
• Demonstrated history of successful clinical product launch.

Education & Work Experience

• BS in ME or BME, Masters Degree preferred
• 12+ years work experience.
• Preferred:
• 3+ years in implantable medical device design.
• Experience in a venture-funded startup environment.

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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