Senior Manager, Design Quality

Location: Onsite or Hybrid in Boulder, CO

About Our Company

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About The Role

The Sr Manager of Design Quality will lead a team of design engineers responsible for ensuring products are developed, implemented, and maintained in compliance with regulatory standards such as CLIA, NYDOH, ISO15189, IEC62304, ISO13485, ISO27001, and the Code of Federal Regulations.  The role requires working with cross functional teams such as the clinical laboratory, product development, software, and regulatory teams on design, but may also be asked to participate in additional QMS activities to support cross-functional projects and requirements. 

What You Will Do

·       Develop, implement, maintain and continually improve the Quality Management System to include the product development process.

·       Quality engineering including quality planning, risk management, requirements and test reviews, test method development and implementation, design and process verification and validation, post-market monitoring, and investigations.

·       Closely monitor, maintain, and improve the efficiency of processes via regular audits and internal reporting. 

·       Oversee the development and implementation of comprehensive test plans and test cases to assess compliance of products outlined in the product roadmap.

·       Lead cross functional collaboration in designing and implementing validation plans.

·       Develop and implement risk management strategies to identify, assess, and mitigate risks associated with clinical patient testing and product development.

·       Manage a team of engineers responsible for ensuring design controls are compliant with appropriate regulations.

·       Establish and maintain robust quality standards including quality manual and related standard operating procedures. Ensure these systems are effectively communicated, understood, and followed by relevant stakeholders.

·       Support regulatory inspections, ensure preparedness, and appropriate responses to findings and observations.

·       Ensure products are developed according to design principles and appropriate regulations.

·       Work with site lead to provide leadership and oversight for training programs.

·       Perform other duties as assigned.

What You Will Bring

Required Qualifications

·       Minimum 10 years of experience.

·       Proven track record of building and lifecycle management of regulated products.

·       Experience leading audits by regulatory bodies.

·       Experience with regulated product development.

·       Bachelors or Advanced degree in related field such as engineering, biomedical engineering.

Preferred Qualifications

·       Experience in Regulatory Affairs.

·       Experience with molecular and oncology diagnostics.

·       Experience working with Class III or II medical device background in a Quality Leadership role. Quality System Regulations knowledge (ISO 13485).

·       Project management experience with PMP or Lean training.

·       Quality Certifications such as CQPA.

Physical Requirements

This position requires the ability to communicate clearly and accurately verbally and in writing, to sit for extended periods, stand, and walk, and to utilize basic office equipment including a computer, keyboard and mouse. This position will lift up-to 10 pounds regularly, and up to 20 pounds occasionally. The position works in a climate-controlled environment, primarily indoors in an office setting.

Compensation & Benefits

This role is hiring at an annual salary of $140,000 - $180,000 and is eligible for equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, health savings accounts, flexible spending accounts, and a 401k with company match. 

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.