Sr. Mechanical Engineer - Systems, Adona Medical

Adonamed; Los Gatos (CA); On-site; USD 130,000 - 160,000; Full time

Job summary

Adona Medical is seeking a Sr. Mechanical Engineer in Los Gatos, CA, focused on designing innovative medical device solutions for heart failure. The position involves cross-functional collaboration, compliance with medical standards, and opportunities for personal and professional growth within a dynamic team.

Benefits

Medical insurance

Vision insurance

401(k)

Disability insurance

Qualifications

• 5+ years work experience, including academic lab experience.
• Experience in medical device standards and risk management.
• Experience in design and prototyping.

Responsibilities

• Design and integrate mechanical enclosures and electromechanical components.
• Conduct mechanical, thermal, and electromagnetic analysis of systems.
• Prepare technical documentation and ensure compliance with standards.

Skills

Mechanical analysis

Thermal analysis

Electromagnetic analysis

CAD design

Communication

Design Controls

Education

BS in Mechanical Engineering

Advanced degree in a technical discipline

Tools

SOLIDWORKS

Matlab

Job description

Sr. Mechanical Engineer - Systems, Adona Medical

Sr. Mechanical Engineer - Systems, Adona Medical

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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

$130,000.00/yr - $160,000.00/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

We are seeking a hands-on Sr. Mechanical Engineer to bring creativity, intellectual rigor and an effective balance of theory and empiricism to mechanical designs. You will take a proactive stance in solving design challenges and thrive in a highly collaborative, cross-functional environment. This role involves designing mechanical enclosures and electromechanical components, implementing robust strategies to enhance the overall system performance. You will collaborate with cross-functional teams, including industrial designers, electrical, and systems engineers, to ensure seamless integration of mechanical designs. Additionally, you’ll ensure compliance with stringent medical standards, focusing on electromechanical safety and electromagnetic compatibility (EMC/EMI) requirements. This is a unique opportunity to apply your expertise towards the development of a transformative medical device that significantly improves the lives of heart failure patients. This is a full-time onsite position and will require reporting to our offices located in Los Gatos, CA.

Responsibilities, Skills & Hands-On Experience

• Design, development and integration of enclosures and electromechanical components (e.g., cable harness assemblies) for medical device capital equipment systems.
• Mechanical, thermal, and electromagnetic analysis and test of medical device capital equipment systems.
• Knowledge of standard manufacturing techniques (e.g. molding, sheet metal, machining).
• Working with external vendors on component design, tolerance stack-up, and design for manufacturability.
• Managing and working with external industrial designers to ensure a seamless integration of the industrial design with the mechanical design.
• Work as part of a cross-functional team on test method development for both characterization and verification/validation testing.
• Working with and managing external test houses for mechanical safety compliance testing of electromechanical designs (e.g., IEC60601-1, 60601-1-2, and transit simulation testing).
• Specification development including mechanical tolerance stack-ups
• Prepare technical documentation, including mechanical specifications / drawings, manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions.
• Participate in and present at, design / technical reviews and periodic department level meetings.
• Train operators and technicians on product assembly; troubleshoot assembly process issues.
• Design and construction of bench test systems.
• Familiarity with Microsoft Excel for data analysis and/or Matlab.
• Proficient in CAD design software.
• Rapid prototyping using 3D printing.
• Strong verbal and written communications skills.
• Ability to work both independently and collaboratively in a team setting.
• Contribute to the company’s intellectual property via invention disclosures, brainstorming sessions, and prototypes to demonstrate reduction to practice.
• Strong understanding of EMC and ESD best practices in mechanical design.
• Working knowledge of medical industry standards, Design Controls, and Risk Management (IEC 60601, ISO 13485, ISO 14971).

Preferred Skills & Hands-On Experience

• Proficiency with SOLIDWORKS.
• Working knowledge of Altium or other PCB layout tools.
• Working knowledge in using electronic test equipment (oscilloscopes, DVMs, and spectrum / vector network analyzers).
• Project planning and management for aspects of the system under engineer’s authority.
• Experience using COMSOL, ANSYS, or other commercial multi-physics simulation package for linked electromagnetic and thermal modelling.
• Basic machine shop skills (manual lathe, mill, drill press, hand tools).
• Vendor selection and management.
• Demonstrated history of successful clinical product launch.
• Experience in a venture-funded startup environment.

Education & Work Experience

• BS in Mechanical Engineering or related discipline.
• 5+ years work experience, including equivalent academic lab experience.
• Preferred: Advanced degree in a technical discipline.

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 $130,000 to $160,000 + 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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