Senior Manufacturing Engineer

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.