Staff Mechanical Engineer

We are seeking an innovative and highly motivated Mechanical Engineer who will contribute significantly to the development of cell therapy solutions. 

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.

Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a broad range of challenges as the company grows.

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

• BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience

• 10+ 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