Job details

Principal Mechanical Engineer - Consumables

We are seeking an innovative and highly motivated Mechanical Engineer who will contribute significantly to developing our advanced cell therapy manufacturing platform. The primary focus of this position will be the design, prototyping, production, and verification of highly complex plastic injection-molded consumable assemblies.

As a Principal Mechanical Engineer (consumables), you will be responsible for component selection, design tasks, manufacturing coordination, sterilization coordination, and initial quality assurance efforts of both individual components, and finished assemblies. Additionally, you will be required to provide in-depth analysis and CAD data to help guide important decisions during design reviews.

This is a multidisciplinary role, and this individual will further interface across many parts of the company to develop novel products used in cell therapy and gene therapy. 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.

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

Responsibilities

Responsible for the design, development, prototyping, 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 & 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

$150,000 - $240,000 a year

Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.

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Average salary estimate

$195000 / YEARLY (est.)

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$150000K

$240000K

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What You Should Know About Principal Mechanical Engineer - Consumables, Cellares

Cellares is on the lookout for a talented Principal Mechanical Engineer specializing in consumables to join our innovative team in South San Francisco, CA. If you're passionate about revolutionizing the cell therapy manufacturing platform, this role is for you! In this hands-on position, you'll play a crucial part in the design, prototyping, production, and verification of highly complex plastic injection-molded consumable assemblies. Your expertise in plastic injection molding, material selection, and component design will be essential as you oversee the entire process, from component selection to manufacturing coordination and initial quality assurance. Collaboration is key, and you'll work closely with R&D and mechanical engineering teams, sharing fresh ideas and tackling design challenges head-on. You’ll also manage relationships with vendors to ensure successful outsourcing of injection molding and assembly operations. If you're eager to innovate and thrive in a fast-paced, mission-driven environment, Cellares is the place to be! Join us in our commitment to advancing cell and gene therapy technologies and make a meaningful impact in this exciting field.

Frequently Asked Questions (FAQs) for Principal Mechanical Engineer - Consumables Role at Cellares

What are the main responsibilities of a Principal Mechanical Engineer - Consumables at Cellares?

The Principal Mechanical Engineer - Consumables at Cellares is responsible for the design, development, prototyping, and volume manufacturing of complex injection molded assemblies. This role involves specifying tooling, developing manufacturing test fixtures, and collaborating with R&D and mechanical engineering teams to create feasible product designs. A core duty also includes managing vendor relationships for injection molding and assembly processes.