Staff Mechanical Engineer (Consumables)

AdeptSource (Adeptsource Inc); South San Francisco (CA); On-site; USD 90,000 - 200,000; Full time

Job summary

An established industry player is seeking a Staff Mechanical Engineer to lead the development of cutting-edge biotech instruments. This hands-on role involves designing and prototyping mechanical components, conducting design reviews, and collaborating with multidisciplinary teams to create innovative solutions. The ideal candidate will bring extensive experience in biotech automation and a passion for driving projects from concept to execution. Join a dynamic team dedicated to pushing the boundaries of technology and making a significant impact in the biotech field.

Qualifications

• 12+ years of hands-on experience in biotech automation or similar industries.
• Knowledge of FDA regulations and ISO, cGMP, and QMS standards is a plus.

Responsibilities

• Design and prototype mechanical components for biotech instruments.
• Conduct design reviews and present innovative solutions.

Skills

Mechanical Design

Fluidic Control

Biotech Automation

Problem-Solving

Analytical Skills

Interpersonal Skills

Education

BS in Mechanical Engineering

MS in Mechanical Engineering

Tools

SolidWorks

Machine Shop Tools

Job description

Job Title: Staff Mechanical Engineer
Location: On-site – South San Francisco, CA (relocation package available)
Type: Full-Time FTE Salary range $90,000 - $200,000


The primary focus of this position will be to develop, test, and assemble critical engineering subsystems. As a Staff Mechanical Engineer, you will take ownership of a wide range of tasks pertaining to high-value internal projects - from requirements capture to novel concept research & development, to CAD design and component selection, to bring-up and testing of finished assemblies.

During this process, you will be required to provide in-depth analysis and help guide important decisions during design reviews and architecture discussions. You will create novel concepts through research and drive rapid feasibility studies with data collection.

This is a multidisciplinary role & this individual will interface across many parts of the company (with scientists, researchers, and engineers) to develop the best solutions possible. The successful candidate will be a resident expert in the areas of mechanical design, fluidic control, and highly automated instrument development. This is a hands-on position located onsite in South San Francisco, CA.

Responsibilities

• Responsible for the design, development, and prototyping of mechanical components and consumables used in mechanical sub-systems & complex biotech instruments
• Design and development of automated test fixtures to validate the reliability and robustness of novel components
• Interface with systems & mechanical engineering teams to negotiate designs that meet product requirements & are feasible to manufacture economically
• Conduct design reviews and present fresh ideas, new technologies, and creative solutions to design problems
• Define subsystem architecture
• Show proof of concept through rapid prototyping
• Ability to extract design requirements from a broad spectrum of user needs
• Identify potential design risks and provide a path to derisk/pivot rapidly
• Work closely with the scientific team through the creation of verification /validation protocols (IQ, OQ, PQ) and successful execution, data generation, report and documentation
• Create comprehensive work instructions and manufacturing SOPs as needed for finished designs

Requirements

• BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience
• 12+ years of extensive, hands-on experience in biotech automation, semiconductor, or similar industries
• Excellent verbal, written, presentation, and interpersonal skills
• Strong analytical and problem-solving skills
• Prior experience with FDA regulations and ISO, cGMP, and QMS standards is a plus
• Knowledge and/or hands-on experience with machine shop tools a plus
• Knowledge of GD&T, as well as strong proficiency with SolidWorks
• Creative, self-motivated, and flexible to work in a small company environment and assume a wide variety of tasks
• Work history with several successful iterations of highly automated instrument design and development (biotech industry experience preferred)
• Desire to be part of a rapidly evolving organization with compelling technology and take products and processes to the next level
• Experience with Python, or high-level scripting software languages, a plus
• Self-awareness, integrity, authenticity, and a growth mindset