Job Description
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.
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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.
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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.
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