Current jobs related to Associate Director, Design Control Quality Engineering - Hayward - Predicine, Inc

  • Senior Quality Assurance Engineer

    4 weeks ago

    Hayward, California, United States Aperia Technologies Full time

    About Aperia TechnologiesAperia Technologies is a leading innovator in the field of commercial vehicle fleets, developing cutting-edge hardware and data analytics solutions to unlock efficiency and sustainability. Our award-winning products, such as the Halotm Automatic Tire Inflator and the Halo Connect tire analytics platform, have revolutionized the...

  • Associate Director, Toxicology

    3 months ago

    Hayward, United States Eikon Therapeutics Full time

    Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of...

  • Mechanical Design Engineer II

    4 weeks ago

    Hayward, California, United States Ultra Clean Technology Systems & Svc Inc Full time

    Job SummaryWe are seeking an experienced Mechanical Design Engineer II to join our team in Hayward, CA. As a key member of our design team, you will be responsible for designing, developing, and implementing cost-effective methods of testing and troubleshooting systems and equipment.Key ResponsibilitiesDesign and develop test equipment and fixtures to ensure...

  • Software Quality Assurance Engineer

    4 days ago

    Hayward, California, United States Predicine Inc Full time

    Predicine Inc is a global molecular insights company committed to advancing precision medicine in oncology. Our team is seeking an experienced Software Quality Assurance Engineer to help us develop and implement our software test and validation strategy within a regulated environment.This role is key for ensuring the quality of our software systems, while...

  • Major Construction

    3 months ago

    Hayward, United States Control Air Enterprises LLC Full time

    Job Summary:Control Air Enterprises LLC is looking to hire an organized, timely, and respectful project engineer with a minimum of a bachelor’s degree in engineering, architecture or construction management to join our North office (Hayward, CA). The project engineer must have short- and long-term processing abilities and demonstrate their ability to...

  • Quality Engineering Manager

    3 weeks ago

    Hayward, California, United States CalTek Staffing , Inc. Full time

    Quality Engineering ManagerJob Summary:We are seeking an experienced Quality Engineering Manager to lead and enhance our Quality Management System (QMS) while driving process improvement, regularly interacting with customers, and maintaining rigorous quality control.This hands-on role will work shoulder-to-shoulder with senior leadership to maintain...

  • Quality Control Technician Site Construction

    1 month ago

    Hayward, United States VEEV Full time

    Quality Control Technician - Site Veev is leading the way in the transformation of the construction industry with an innovative approach to modular home construction. Veev's prefabricated closed panel systems allow homes to be assembled efficiently on-site while delivering both a more sustainable and higher quality final product than traditional...

  • Quality Control Technician

    1 month ago

    Hayward, United States VEEV Full time

    Quality Control Technician - Site Veev is leading the way in the transformation of the construction industry with an innovative approach to modular home construction. Veev's prefabricated closed panel systems allow homes to be assembled efficiently on-site while delivering both a more sustainable and higher quality final product than traditional...

  • Software Quality Assurance Engineer

    7 days ago

    Hayward, California, United States Predicine, Inc Full time

    Job Title: Software Quality Assurance EngineerAbout the Role: We are seeking an experienced Software Quality Assurance Engineer to join our team at Predicine, Inc.Job Description: As a Software Quality Assurance Engineer, you will be responsible for developing and implementing software verification and testing systems, working with software and DevOps...

  • Manufacturing Quality Control Specialist

    7 days ago

    Hayward, California, United States VEEV Full time

    Veev is revolutionizing the construction industry with its innovative approach to modular home construction.The company's prefabricated closed panel systems enable efficient on-site assembly, resulting in a more sustainable and higher-quality final product compared to traditional construction methods.As a subsidiary of Lennar, Veev leverages the strength and...

  • Project Delivery Director

    1 week ago

    Hayward, California, United States Lonza, Inc. Full time

    At Lonza, Inc., we're seeking a highly skilled Project Delivery Director to join our team. This is an exciting opportunity to lead investment projects from planning to execution, ensuring timely completion, budget adherence, and quality standards.Key Responsibilities:Develop and execute project plans, including Engineering, Design, Construction,...

  • Manufacturing Engineer

    7 days ago

    Hayward, California, United States AEM Full time

    Job SummaryAEM is seeking a highly skilled Manufacturing Engineer to support the design and development of electromechanical systems. The successful candidate will be responsible for designing mechanical and electromechanical fixturing and systems for production, solving quality issues with production operations and supplied materials, and designing...

  • Electrical Design Engineer

    1 week ago

    Hayward, California, United States Lithos Energy Inc Full time

    Job Title: Electrical Design EngineerWe are seeking a highly skilled Electrical Design Engineer to join our team at Lithos Energy, Inc. Our company is a growing team of experienced engineers and we pride ourselves in our ability to deliver reliable, high-quality, and safe products to our customers.Responsibilities:* Assist in board-level electronics design,...

  • Manufacturing Quality Control Technician- Night Shift

    4 weeks ago

    Hayward, United States VEEV Full time

    Veev is leading the way in the transformation of the construction industry with an innovative approach to modular home construction. Veev's prefabricated closed panel systems allow homes to be assembled efficiently on site while delivering both a more sustainable and higher quality final product than traditional construction. As a new subsidiary of Lennar,...

  • Mechanical Design Engineer II

    1 month ago

    Hayward, California, United States UCT Alumni Association Full time

    Job SummaryWe are seeking an experienced Mechanical Design Engineer II to join our team in Hayward, CA. The successful candidate will design, develop, and implement cost-effective methods of testing and troubleshooting systems and equipment.Key ResponsibilitiesDesign and develop test and diagnostic programsDesign automated test fixtures and equipmentConduct...

  • Manufacturing Quality Control Specialist

    2 weeks ago

    Hayward, California, United States VEEV Full time

    Quality Control InspectorVeev is revolutionizing the construction industry with its innovative approach to modular home construction. Our prefabricated closed panel systems enable efficient on-site assembly, delivering a more sustainable and higher-quality final product than traditional construction methods. As a subsidiary of Lennar, Veev leverages the...

  • Mechanical Design Engineer II

    2 weeks ago

    Hayward, California, United States UCT Alumni Association Full time

    Job Summary:The Mechanical Design Engineer (test equipment) will be responsible for designing, developing, and implementing cost-effective methods of testing and troubleshooting systems and equipment.This role requires preparing test and diagnostic programs, designing automated test fixtures and equipment, and completing testing procedures for new...

  • Mechanical Design Engineer II

    3 weeks ago

    Hayward, California, United States UCT Alumni Association Full time

    Job Summary:The Mechanical Design Engineer (test equipment) will be responsible for designing, developing, and implementing cost-effective methods of testing and troubleshooting systems and equipment. This role requires preparing test and diagnostic programs, designing automated test fixtures and equipment, and completing testing procedures for new products....

  • Mechanical Design Engineer II

    1 week ago

    Hayward, California, United States UCT Alumni Association Full time

    Job Summary:The Mechanical Design Engineer II will be responsible for designing, developing, and implementing cost-effective methods of testing and troubleshooting systems and equipment.This role requires preparing test and diagnostic programs, designing automated test fixtures and equipment, and completing testing procedures for new products.The successful...

  • Office Administrator

    2 months ago

    Hayward, United States Heat and Control Full time

    Here at Heat and Control, we're always seeking talented minds to join our team of engineers and change-makers. We partner with global industry leaders to design, engineer, and build production machinery that creates world famous food and consumer products, and we’d love for you to join our team as an Office Administrator in Galesburg, Illinois.Check all...

Associate Director, Design Control Quality Engineering

2 months ago

Hayward, United States Predicine, Inc Full time
Job DescriptionJob Description

Predicine is a molecular insight company developing genomic profiling tests and robust algorithms for cancer diagnostics and monitoring. Our biology-oriented approach to analyzing genomics is advancing the understanding of tumor mutational landscape. We are applying our expertise in genomic profiling to identify elusive cancer-related genetic changes and new biomarker targets across many cancer types. Our advanced cancer genome analysis helps researchers and biopharmaceutical partners accelerate new precision medicine development. 
At Predicine, we are passionate about our people, technology, and creating a lasting impact in cancer research.

If you enjoy challenges, collaborating with others to solve complex problems, and the chance to see your work impact the millions of lives touched by cancer, we invite you to join us

Associate Director, Design Control Quality Engineering:

  • Establish and maintain the IVD/IVDR medical device design control process and the software design life cycle as it applies to the launch of Class III domestically and internationally.
  • Oversee development and implementation of quality policies and procedures used to support the development cycle of a Companion Diagnostic from feasibility to product launch and maintenance, and transfer to sustaining manufacturing.
  • Create appropriate Design History File (DHF) documents and templates according to the regulatory guidelines and maintain DHF documents during all phases of design control process.
  • Drive the design control process and provide guidance and support for DHF documents.
  • Review the DHF and technical files for conformance to applicable requirements.
  • Provide guidance and support for design verification/validation activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes and quality of the test spec.
  • Familiarity with GxP Regulations, Quality Management Systems (including e-QMS), EDMS, ISO Standards applicable to Medical Devices, CLSI Standards applicable to IVD Product Performance, FDA Regulatory pathways. Assume responsibilities for the creation and maintenance of the risk management files associated with the individual DHF’s. Draft Quality SOPs, as needed and as applicable, to Product Development lifecycle
  • Review study protocols and reports for compliance with SOPs and regulations.
  • Collaborate with Development, Laboratory Operations, Automation, IT/Software, and Computational Research/Bioinformatics to develop, verify and validate all new processes and methods.
  • Lead and participate in dMFEA and pFMEA activities, maintain and update Risk Management documents.
  • Support internal and/or external audits.
  • Support Predicine Lab (s) to be compliant with GCP, GLP, GMP and other applicable requirements prior to testing patient samples in a CDx clinical validation study.
  • Support qualification and validation of supplier/vendors as needed.
  • Train other departments on the design control and software design lifecycle requirements and processes.
  • Demonstrate critical thinking, excellence, and speed when interacting with external partners and with regulatory authorities.
  • Other tasks and projects as assigned.

Qualifications:

  • Bachelor’s degree in biology, engineering or healthcare field(s). Advanced degree (i.e. M.S. or Ph.D.) is preferred but not required
  • CDx/PMA study management experience is desirable.
  • Liquid biopsy testing, or next-generation sequencing (NGS) experience is desirable.
  • Diagnostic IVD experience is required.
  • Minimum of 8 years’ experience effectively utilizing/implementing the quality management system and product development process.
  • Experienced in risk assessment compliant to EN ISO 14971 as it applies to the product development processes.
  • Experienced with the implementation and execution of a software design lifecycle compliant to IEC 62304 Software Design Life Cycle.
  • Experienced with the implementation and execution of a design control process compliant to 820.30 (Design Control) and ISO 13485 (7.3 Design and Development), Current Good Manufacturing Practices (cGMPs), in addition to CLIA, CAP and NYSDOH guidelines.
  • Experienced with creating and maintaining Design History Files/Technical Files. 
  • Excellent written and verbal communication skills.
  • High quality standards and attention to detail when authoring and reviewing documents.
  • Able to distill complex issues and clearly articulate solutions.
  • Demonstrated learning agility to quickly grasp new concepts and apply them in an entrepreneurial environment.

 Our Opportunity:

We are not accepting third party resumes from recruiters, recruiting agencies or 3rd party vendors.

Candidate location: California/Remote

All full-time roles in the US come with a robust benefits package which includes healthcare, dental, and vision insurance. Additional benefits include PTO, paid holidays and 401(k) retirement plan.

Salary: 140K-175K

The posted salary range is the estimated base salary range for this position. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data.

We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. All your information will be kept confidential according to EEO guidelines. We require all Predicine employee's to be fully vaccinated and provide proof of vaccination on their first day of work.

All job offers are contingent upon successful completion of background verification.

Applicants must be legally authorized to work in the USA.