Executive / senior industry position
OVERVIEWGenomic Health is seeking a highly motivated and collaborative individual to lead the Systems Engineering development of regulated and distributed in-vitro diagnostic (IVD) products for oncology. This position plays a key leadership role in bringing new products, product systems, and services to physicians which will help inform treatment decisions for patients with cancer. The Systems Engineering Associate Director/Director will work within a cross-functional Core Team to lead systems design, interoperability and usability requirements documentation, V&V planning and execution. This person will work closely with Quality Assurance and Regulatory to enable successful regulatory filings in Europe (IVDR/IVDD) and/or the US (510(k)/PMA). This person will oversee initial feasibility studies and development activities under the Quality Management System and following Genomic Health's Product Development Process. The ideal candidate will be a hands-on subject matter expert, a strong leader and influencer with a proven track record in successful IVD product development. RESPONSIBILITIES· Accountable for "building the right product, right"· Owner of the document tree from customer requirements to validation spanning entire V-model and accountable for:o design of requirements architectures that are leverageable across products and design changes incorporating hardware, software, and reagentso subsystem definition, requirements hierarchy, and flowo writing requirements that are clear, attainable, and testableo trace of design inputs to design outputso risk management activities from PHA to FMEA· Collaborates with Quality to ensure DHF is auditable, clear and provides an excellent template for future programs · Communicate and collaborate closely with functional area leads and Core Team members to develop requirements, test plans, and V&V activities · Contribute to usability testing planning with customers and clinicians to iterate on product design· Drives system integration and optimization with cross-functional Core Team· Provide plans and resource estimates for investigational and development activities.· Assists in the definition of key development deliverables, milestones, dependencies, risks and mitigations as part of the Integrated Program Plan.· Communicate and collaborate closely with functional area leads and Core Team members including product management, program management, clinical, quality assurance, regulatory affairs, assay development, software development, and operations to transform strategy into execution.· Ensure all development activities are conducted in adherence to applicable national/international regulations, guidelines, company policies, SOPs, and industry standards.QUALIFICATIONS· BS degree in Science or Engineering with a minimum of 12 years of experience in medical device or IVD industries or MS/Ph.D. degree in Science or Engineering with a minimum of 5 years in medical device or IVD industries. · Proven track record as a leader developing diagnostic tests, reagent kits or diagnostic systems.· Understanding of ISO 13485 standard and Code of Federal Regulations (CFR) 21§ 820.30 Design Controls and previous experience developing products under design control as well as risk management standards (e.g. ISO 14971)· Experience in complying with IVDD (98/79/EC) and IVDR· Detailed knowledge of requirement management and risk-based testing approaches· Experience assembling documentation to support ISO, CE mark, 510(k) and/or PMA submissions.· Scientific and business acumen leading to data-driven decisions.· Strong ability to maintain open communication with internal employees, managers, and customers as needed.· Able to integrate and apply feedback in a professional manner.· Able to prioritize and manage multiple concurrent projects and drive to results with a high emphasis on quality.· Demonstrated excellent oral, written and presentation-based communication and influencing skills.· Able to integrate and apply feedback in a professional manner· Demonstrated ability to be highly effective in a fast-paced, rapid growth environment and a strong team player.· Good communicator with the ability to maintain open communication with internal employees, managers, and customers as needed.· Ability to work as part of a team.CORPORATE OFFICE JOBS: TRAVEL, PHYSICAL/MENTAL DEMANDS, AND WORK ENVIRONMENT:· Travel Requirements: International travel possible once a quarter for 3-4 days.· Use of computer, and or telephone for long periods of time may be necessary.· Considerable periods of time may be spent communicating verbally and in various written forms including presentation material and email with other people · At times, stress may be experienced. · Standing or sitting for long periods of time may be necessary.· May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
This person will work closely with Quality Assurance and Regulatory to enable successful regulatory filings in Europe (IVDR/IVDD) and/or the US (510(k)/PMA). This person will oversee initial feasibility studies and development activities under the Quality Management System and following Genomic Health’s Product Development Process. The ideal candidate will be a hands-on subject matter expert, a strong leader and influencer with a proven track record in successful IVD product development.