Cell Therapy Mechanical Engineer - Consumables

YOH Services LLC; South San Francisco (CA); On-site; USD 150,000 - 240,000; Full time

Job summary

An established industry player is seeking a Cell Therapy Mechanical Engineer to lead the design and production of innovative consumable assemblies. This hands-on role focuses on plastic injection molding and requires extensive experience in biomedical device design. You will collaborate with R&D teams, manage vendor relationships, and ensure compliance with industry standards. If you have a passion for advancing technology in the life sciences sector and thrive in a dynamic environment, this opportunity is perfect for you. Join a team dedicated to making a significant impact in cell and gene therapy.

Qualifications

• 15+ years of hands-on experience with plastic injection molding.
• 5+ years designing one-time-use tubing sets for medical or biotech.
• Strong proficiency with SolidWorks CAD tools.

Responsibilities

• Design and develop complex injection molded assemblies.
• Work closely with R&D and engineering teams to meet product requirements.
• Create comprehensive work instructions and manufacturing SOPs.

Skills

Plastic Injection Molding

Component Design

Design Optimization

Materials Science

DFM and Lean Manufacturing

Analytical Skills

Problem-Solving Skills

FDA Regulations Knowledge

Interpersonal Skills

Tools

SolidWorks

Machine Shop Tools

Job description

Cell Therapy Mechanical Engineer - Consumables

Category:

Life Science

Employment Type:

Direct Hire

Reference:

BH-384977

Yoh Life Sciences
is hiring for a Cell Therapy Mechanical Engineer
for consumables in South San Francisco. The Mechanical Engineer will focus on design, prototyping, production, and verification of highly complex plastic injection-molded consumable assemblies. The successful candidate will be experienced in plastic injection molding, material selection, and component selection for complex biomedical consumable device design. This is a hands-on position and will require you to be onsite.

Industry:
Cell and Gene Therapy
Location:
South San Francisco
Compensation: $150,000 - $240,000
Shift:
M- F 8-5pm

Responsibilities:

• Design, develop, prototype, and volume manufacturing of complex injection molded assemblies and high-precision mechanical components & assemblies


• Specifying injection molding tooling with state-of-the-art capabilities: Variotherm, vacuum assist, hot runners, etc


• Design and development of manufacturing test fixtures as required


• Identify & interface with key component vendors (suppliers of tubing, valves, etc, that may be integrated into our consumable design)


• Interface with R&D 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


• Show proof of concept through rapid prototyping


• Work closely with the scientific team through the creation of verification/validation protocols (IQ, OQ, PQ) as well as successful execution, data generation, reporting, and documentation


• Work with external companies as needed to outsource injection molding activities and manage the vendors through all phases of the projects, including user requirements, RFQ, vendor selection, and concept & design, followed by verification/validation


• Work with external companies as needed to outsource consumable assembly and sterilization activities through all phases of the project(s)


• Create comprehensive work instructions and manufacturing SOPs as needed

Requirements:

• 15+ years of hands-on experience with plastic injection molding, including but not limited to component design, design optimization, mold design


• 5+ years of experience designing and building one-time-use tubing sets or consumables for the medical or biotech industry


• In-depth knowledge of materials science/plastics properties and metrology techniques


• Experience with drafting engineering drawings, BOMs, and product specifications


• Good understanding of DFM and lean manufacturing


• Excellent verbal, written, presentation, and interpersonal skills.


• Strong analytical and problem-solving skills


• Prior experience with FDA regulations and ISO, cGMP, QMS standards


• Prior experience with USP class VI materials


• Knowledge and hands-on experience with machine shop tools


• Strong proficiency with SolidWorks CAD tools


• Work history with several successful iterations of molded components transferred successfully to volume manufacturing


• Working knowledge of manufacturing techniques, including machining, injection molding, and bonding of consumables (ultrasonic welding, laser welding) for biotech components


• Desire to be part of a rapidly evolving organization with compelling technology, and ready to take products and processes to the next level


• Self-awareness, integrity, authenticity, and a growth mindset.

#IND-SPG

Estimated Min Rate: $150000.00
Estimated Max Rate: $240000.00

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities

to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.