Senior Manufacturing Engineer

Nutcrackerx; Emeryville (CA); On-site; USD 145,000 - 168,000; Full time

Job summary

A pioneering company in mRNA development is seeking a Senior Manufacturing Engineer to lead efforts in biochip manufacturing. The ideal candidate will have a degree in engineering and at least five years' experience, driving improvements and ensuring compliance in a fast-paced environment. We offer competitive salaries and comprehensive benefits.

Benefits

Medical, Dental, Vision Insurance

401(k)

PTO plan

Employee stock options

Qualifications

• Minimum 5 years' experience in manufacturing process engineering.
• Experience in FDA GMP/ISO environment.
• Lean manufacturing and Six Sigma experience preferred.

Responsibilities

• Lead manufacturing process engineering for biochips and consumables.
• Drive continuous improvement initiatives for process performance.
• Collaborate with cross-functional teams for technology transfer.

Skills

Structured problem-solving techniques

Data analysis

Collaboration

Education

B.S. degree in Mechanical, Biomedical, Aeronautical, Industrial, Manufacturing Engineering

Tools

3D CAD (Solid Works)

Statistical analysis software

Microsoft Office suite

Job description

Pick a challenge that is bigger than your lifetime.

New ideas are all around us, but only a few will change the world. That’s our focus at Nutcracker. We are an early-stage company looking at mRNA and its production in a completely different way. We are challenging the conventional and merging both innovative science with engineering to not just save lives, but to improve the manufacturing and delivery of critical health solutions. Yes, as our name implies, we are working to crack some of the toughest scientific and engineering nuts out there. If you are driven to discover, create, and inspire something that moves science and technology forward, and lasts a lifetime and beyond, you’re ready to be a Nutcracker.

In summary, you will:

Be responsible for leading process engineering efforts in the manufacturing of biochips and consumables, ensuring all operations meet established process and product specifications, supporting GMP and regulatory compliance. Drive continuous improvement initiatives to optimize yield, quality, and efficiency. Collaborate cross-functionally with R&D, quality, and production teams to support scale-up, validation, and troubleshooting activities. Maintain a strong focus on process control and data-driven decision-making to ensure a robust and reliable manufacturing operation.

Responsibilities

• Responsible for biochip & consumables manufacturing process engineering, which includes processes; laser cutting, metrology, deposition, plasma systems, lamination equipment, vacuum ovens and Nutcracker Manufacturing Unit-Final release testing
• Lead continuous improvement projects (CIP) to streamline and improve process performance, yield, cost and cycle time
• Perform equipment and process DOEs; maximizing product quality, build consistency, efficiencies, and thru-puts
• Lead, facilitate, and assist in risk assessments (pFMEA, FMECA), gap analyses, and other related risk analyses
• Use structured problem-solving methodologies to implement containment, corrective actions, identify root-cause and develop solutions that can be implemented in manufacturing
• Analyze data using statistical tools and software to identify trends, patterns, and opportunities for process improvements. This may include performing data cleaning and preprocessing, conducting statistical analyses, and developing control charts, process trend charts to help visualizations to communicate results
• Work with cross-functional teams to ensure successful technology transfer of processes and equipment into manufacturing. This may involve assisting with the design and implementation of scale up experiments, troubleshooting process issues, and collaborating with cross-functional teams to address technical challenges
• Work and maintains day-to-day relationships with external equipment vendors, to facilitate process/equipment issues, PM’s and calibration
• Assist in the preparation of technical reports, presentations, and other documentation to support process manufacturing engineering and optimization efforts. This may include summarizing experimental results, developing recommendations for process improvements, and presenting findings to internal and external stakeholders
• Perform equipment IQ/OQ/PQ
• Investigate, plan, and implement product/process changes which directly improve the product quality and reliability, enhance process capability, and reduce manufacturing cost of products
• Work with suppliers, quality, and R&D to troubleshoot and systematically investigate supplier non-conformances, followed by resolution implementation
• Work with quality and R&D to implement appropriate incoming inspection checks, ensuring parts consistently meet specification requirements
• Reviewing drawings and specifications for DFM, optimized dimensioning, and tolerancing with focus on quality
• Identify and incorporate continuous improvements using 6S/lean, process improvements, new fixturing or improved fixtures
• Develop manufacturing work, process and test instructions for manufacturing processes, fixtures, test equipment, part specifications, and routers
• Develop/optimize assembly and test fixtures
• Provides direction to Manufacturing Technicians/Operators through training, presentations and GMP examples
• Support on-the-floor Manufacturing production activities, as required
• Collaborate with QA, Materials, R&D, and Production to resolve defects at all levels, pro duction yields and non-conforming issues
• All other duties as assigned

Requirements

• B.S. degree in Mechanical, Biomedical, Aeronautical, Industrial, Manufacturing Engineering, or equivalent experience
• At least 5 years' manufacturing process engineering/operations experience, including skills in DOE process, SPC, FMEA and test characterization, improvement, and validation of a variety of equipment and processes used to build medical devices preferred
• Familiar with structured problem-solving techniques to establish a systematic, step by step approach to identifying, analyzing, and addressing problems
• Experience working in FDA GMP/IS0 environment preferred
• Lean manufacturing, Six Sigma experience a plus
• Experience managing production processes a plus
• Familiarity with industry best practices, GMP and applicable standards
• Experience and knowledge in building quality into process, including process flow and failure mode
• Strong analytical written and verbal communication skills as well as the ability to inter face with all departments and manage multiple projects/deliverables
• 3D CAD experience, i.e., Solid Works
• Good computer software skills with word processing, Microsoft Office suite of products, and statistical analysis software
• Track record of planning and implementing projects to reduce manufacturing costs, improve processes, increase product quality and reliability, and enhance process capability
• Proven ability to deliver results

$145,000 - $168,000 a year

The expected range for Senior Manufacturing Engineer is $145,000 to $168,000 per year based on candidate experience, education, location, and other job-related factors. Employees are also eligible to participate in benefits including Medical, Dental, Vision, Life Insurance, 401(k), PTO plan and employee stock options.

Nutcracker Therapeutics is an early stage life science company building a workplace where highly collaborative and diverse teams thrive. If your best work is performed in a fast-paced entrepreneurial work environment where meaningful work is mastered each day, we’d love to hear from you.

Nutcracker Therapeutics is an equal opportunity employer and values diversity, as such, we do not unlawfully discriminate on the basis of race, color, religion, citizenship, political activity or affiliation, marital status, age, national origin, ancestry, physical or mental disability, medical condition (as defined under California law), veteran status, sexual orientation, gender identity, gender expression, sex or gender (which includes pregnancy, childbirth, breastfeeding, or related medical conditions), taking or requesting statutorily protected leave, or any other basis protected by law.

Agency Disclaimer:

Nutcracker Therapeutics, Inc. (hereafter, Nutcracker) does not accept unsolicited resumes from recruiters or employment agencies in response to the Nutcracker Careers page or a Nutcracker social media post. Recruiters, agencies and other persons need to have written agreement with Nutcracker, and written approval from a Nutcracker Human Resources representative, to submit resumes for a specific position in order to receive credit. Nutcracker will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes and without a written agreement. Nutcracker explicitly reserves the right to hire said candidate(s) without any financial or other obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Nutcracker.