We are seeking a Senior NPI Mechanical Engineer to join the Instrument Manufacturing Engineering Team. This person will be responsible for the development and implementation of manufacturing process improvements, equipment/fixture/tooling design and qualification, process development and qualification, optimized to deliver high quality products and meet production demand.  

The ideal candidate will have a strong background in NPI, mechanical design, manufacturing and process engineering.  This role requires strong mechanical engineering fundamentals, a collaborative mindset, and the ability to work effectively across functional teams including manufacturing, service, operations, and quality.

What you will be doing:

• Lead and support mechanical engineering efforts for NPI, covering design development, verification, validation, and production transfer.
• Design and development of manufacturing test fixtures as required. Design fixtures and tooling to help reduce cost of machine setup and reduce scrap
• Teaming with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes, implement mitigations, and leverage risk based decision making.  
• Create process requirements for both informing design activities, and to  implement equipment and fixturing needed for process development and manufacturing efforts.
• Develop and maintain documentation for design and process control, product configurations, manufacturing procedures, (e.g., travelers, bills-of-materials, Work Instructions, Lot History Records), and other Quality System requirements.
• Evaluate existing engineering processes and implement process improvements. 
• Using Lean principles, Lead and/or actively participate in product/process engineering problem solving.
• Identify opportunities and implement changes to improve products and reduce costs by using knowledge of assembly methods, quality control standards, fabrication processes, tooling, production equipment, product design, and materials
• Support the transfer of product lines and the qualification-validation efforts
• Prepare reports and presentations summarizing information or trends related to manufacturing performance
• Provide technical expertise or support related to manufacturing.

Minimum Requirements: 

• Bachelor’s degree in Engineering: Mechanical, with 5 years of experience, or MS/ PhD with 4 years of experience.
• Strong background in mechanical design for complex capital equipment, ideally including optics, motion systems, and fluidics.
• Ability to review mechanical drawings, ability to read schematics
• Proficient in SolidWorks for 3D CAD modeling, design analysis, and creating detailed mechanical drawings.
• Creation of pFMEAs, ECOs, work instructions, and qualification documentation. 
• Working knowledge of, but not limited to, manufacturing and assembly techniques, machining, injection molding, instrument and consumables for biotech
• Experience working with instrument manufacturing under ISO 9001 or ISO 13485 standards. 
• Expertise in cGDP, cGMP. 
• Ability to travel to contract manufacturers (approximately 10%)
• Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level.

Preferred Qualifications: 

• Experience with DFM/DFT/DFA and process validation in regulated environments (e.g., ISO 13485, FDA).
• Comfortable managing BOMs, ECOs, and documentation in a structured product development environment.

**Due to limited quota, Singaporeans and Permanent Residents may apply.**

About the role

10x Genomics was founded to deliver powerful and reliable tools that fuel key scientific discoveries and drive exponential progress in our mastery of biology to advance human health. Our talented team has a distinguished record of creating innovative instruments, reagents, and software that analyze biological systems at a resolution that matches the complexity of biology.

We are looking for a Technical Lead to join our Instrument Software team.

You have expert-level knowledge of creating advanced instrument control software with C, C++, Python and/or Rust. You handle asyncio, threading, multiprocessing and interfacing with low-level drivers, firmware & hardware with ease. You understand the power and flexibility Python brings, but also its limitations. You are a stickler for testing and thrive on creating a clean and maintainable codebase.

You are the engineer that other engineers can count on; you are technically excellent, you attack every problem with enthusiasm, you care deeply about what it takes to build high quality software. You are a self-starter, team player, have the hunger to venture quickly into unknown areas, code and make the system work.

What you will be doing

• Design and develop production software for 10x instruments
• Design and develop diagnostics tools for fleet monitoring employing AI 
• Architecture and system design of next generation instruments
• Long-term evolution of our instrument codebase
• Hiring and mentoring of local team members in Singapore

Minimum requirements

• Bachelor's degree in computer science, engineering, math, or scientific discipline with 8+ years experience; OR Master’s degree with 6+ years of experience in software development
• Minimum experience of 3 years leading software team(s) in a technical capacity
• Instrumentation system design & architecture
• Modern C++
• Embedded Development
• Python3
• Linux
• Use of AI tools for software development life cycle

Preferred skills and experience

• Control Systems Development
• Firmware Development & EE knowledge (Digital & Analog Design)
• Rapid software prototyping & validation with attention to detail and engineering diligence
• Strong analytical and problem-solving skills
• Strong verbal and written communication skills
• Familiarity with AI aided software development practices and integrating AI into existing tooling.
• Background in biology and DNA sequencing is not required. Interest in the field is.

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About the Role:

As a Senior Mechanical Engineer, you will play a pivotal role in leading the mechanical design of complex biotech consumables from concept through production. You will be a key technical contributor, problem solver, and mentor, working across disciplines to drive innovation and ensure system success. Your expertise in mechanical design, prototyping, testing, and regulatory compliance will be instrumental in delivering high-performance, scalable solutions that meet the stringent demands of biotech environments.

What you will be doing:

• Lead the mechanical design of complex biotech consumables from concept through production
• Focus on injection-molded (IM) plastics, over-molding, LSR, and advanced assembly techniques like ultrasonic welding and laser bonding
• Design for Manufacturing (DFM) and Design for Assembly (DFA), working closely with toolmakers and CMOs to ensure tool designs and strategies are optimized
• Vendor Management - Act as the primary technical point of contact for external molding partners and material suppliers, ensuring quality and performance standards are met
• Contribute to the design and development of high-complexity mechanical systems for biotech applications, ensuring seamless integration with biological and chemical workflows
• Apply advanced engineering principles in mechanics, thermodynamics, fluid dynamics, and materials science to solve intricate design challenges

• Drive prototype development and oversee rigorous validation testing to ensure optimal system performance
• Ensure designs meet relevant regulatory standards (e.g., FDA, ISO, GMP) in partnership with compliance teams
• Drive projects from concept to commercialization, managing scope, schedules, risks, and trade-offs. Identify risks early, and implement mitigation strategies to maintain timelines and budget
• Act as a technical liaison between mechanical engineering and cross-functional teams (e.g., R&D, software, manufacturing, quality assurance) to ensure system integration

• Participate in failure mode analysis and implement corrective design improvements to enhance reliability and manufacturability

• Present project updates and design proposals to project leadership, ensuring alignment with project objectives
• Foster a collaborative team environment, mentoring junior engineers and driving knowledge-sharing initiatives.

Minimum Requirements:

• Bachelor’s or Master’s degree (or equivalent) in Mechanical Engineering or a related field
• Multi-year experience in mechanical design and product development, preferably in biotech, medical devices, or related industries
• Proficiency in CAD tools (e.g., SolidWorks, Creo, or equivalent) and engineering analysis tools
• Strong understanding of mechanical system integration, prototyping, and validation testing
• Experience with regulatory requirements (e.g., FDA, ISO 13485, GMP) for biotech or medical device applications
• Demonstrated ability to lead projects, mentor engineers, and drive cross-functional collaboration

Preferred Qualifications:

• Deep knowledge of thermoplastic resins (COC, COP, PC, PP), elastomers (TPE/TPU), and the nuances of high-volume injection molding
• Experience in fluidic systems, thermal management, or precision mechanics for biotech applications
• Knowledge of manufacturing processes, including injection molding, machining, and 3D printing
• Familiarity with risk assessment methodologies (FMEA, DFMEA, etc.)

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About the role

We are seeking a highly motivated and experienced Senior Compliance Engineer to lead and support hardware and reagent compliance initiatives across global regulatory frameworks. In this role, you will be responsible for interpreting and implementing regulatory requirements, managing product certifications, and ensuring compliance with standards such as UL, CE, FCC, RoHS, REACH, and other international directives. You will collaborate closely with cross-functional teams—including engineering, manufacturing, supply chain, and regulatory affairs—to ensure that all hardware and reagent products meet applicable compliance standards throughout their lifecycle. This position is critical to enabling successful product launches and sustaining market access across key global regions.

What you will be doing:

Hardware Product Compliance:

• Collaborating with a cross-functional team to ensure compliance to regulatory requirements including UL, CSA, FCC, CE, KCC, SRRC, PSE, CB.
• Submitting official certification through relevant compliance bodies such as FCC, CE, UL, TUV, KCC, MIC, SRRC, etc. and acting as a liaison between 10x Genomics and state, local, federal and international agencies to submit required forms and paperwork while maintaining date and files for future reference, particularly in the event of an audit by a regulatory agency.
• Understanding RoHS, REACH, TSCA, Waste Electrical and Electronic Equipment Regulation and ensuring that new and existing products are designed to comply with those guidelines and tested accordingly.
• Determining and interpreting the relevant regulatory standards such as IEC 61010-1, IEC 61010-2-010, IEC 61010-2-081, IEC 60601 and how they apply to 10x Genomics products to establish and maintain guidelines and best design practices to mitigate compliance issues early in the design phase.
• Ensuring compliance with global EMC and EMI regulatory requirements, and working closely with electrical and systems engineering teams to define and implement design guidelines for shielding, grounding, and layout strategies to reduce emissions and improve immunity.
• Staying up to date with any changes to global agency approvals and testing procedures, as well as reviewing marketing, legal and technical documentation (for example: labeling user guides and declaration of conformity) to assess compliance with regularly reporting on compliance status and measures to both internal and external parties.
• Maintaining a deep understanding of new and existing regulation that may impact 10x Genomics products and processes and using that understanding to standardize all business operations and establish clearly documented protocols while explaining regulations, procedures and policies to all employees and stakeholders as necessary.
• Preparing Manufacturing site ready for the Regulatory Body audit for Product Safety Certification. Establishing a routine manufacturing test equipment Program for Hipot & Ground Bond testing, and managing bi-annual audits with external regulatory agencies for Product Safety Certification.

Minimum Requirements:

• Minimum of Bachelor’s degree in Electrical Engineering or related engineering field
• Given the complexity and narrow scope of business requirements, we also require Senior Regulatory Compliance Engineer, to have several years of experience and expertise in electrical engineering processes and procedures
• 10+ years of experience in regulatory compliance for hardware products, reagents, or both—preferably within the life sciences, diagnostics, or medical device industries
• Additional Experience with chemical and reagent compliance, including SDS authoring, GHS/CLP labeling, and familiarity with REACH, TSCA, and international chemical inventory regulations is strongly preferred
• Familiarity with environmental regulations (RoHS, REACH, WEEE, TSCA, etc.) and how they apply to product design, component selection, and global distribution
• Strong project management skills, with the ability to manage multiple regulatory timelines and interact with cross-functional teams (e.g., R&D, manufacturing, supply chain)
• Excellent technical writing and documentation skills, including experience with compliance reports, regulatory submissions, and audit-ready file maintenance
• Ability to interpret regulatory language and apply it practically to product development and compliance strategies
• Experience with software coding is an added advantage. 

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