Senior Engineer - Research & Development - Medical Device Quality

Facility:  Engineering
Location: 

Fremont, CA, US

About the Department                                                                                                                                     

Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy. This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes. Type 1 Diabetes is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels. It is usually diagnosed in children and young adults. Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests. This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson’s and chronical heart failure.  Are you ready to make a difference?

 

The Position

The Senior Medical Device Quality Engineer will be responsible for Quality oversight and support for product development teams, and development and maintenance of the Quality Management System (QMS) to support the regulated development of devices intended to prepare and administer doses of cellular medicines.  Duties include Quality oversight over design control, risk management, and human factors/usability activities with development teams and medical device supplier/testing partners.  The Quality Engineer is an expert in the statistics of quality including establishing sample sizes, statistical analyses and establishing acceptance criteria.  The Device Quality Engineer is and active member of the core product development team responsible for approving design control deliverables, assisting investigation and design change closure in a timely manner, supporting review of regulatory product submission filings and supporting continuous improvement efforts for medical device development related processes.

 

Relationships

Reports to a leader in Cell Therapy Medical Devices. Interacts with key company personnel both within and outside of Novo Nordisk as related to product development programs. Develops and maintains positive rapport and working relationships with other personnel in Cell Therapy R&D, and other partner departments within Novo Nordisk in support of initiatives and to accomplish company goals. 

 

Essential Functions

  • Work within cross-functional teams to develop new medical device designs to solve a wide range of technical challenges.  Develop devices considered combination products in conjunction with cellular medicines and related formulations.
  • Writes, reviews and approves protocols, performs analyses and writes, reviews and approves reports compliant with Design Controls as part of formal Design Verification & Validation.
  • Develop and support verification and validation activities to ensure that product designs meet the customer needs, including bench testing, model/fixture development, ex vivo and/or in vivo testing as appropriate. 
  • Prepare documentation to support Design Reviews at respective design control milestones. 
  • Demonstrates a thorough knowledge of medical device development compliant with requirements for Europe (MDR, ISO 13495) and the USA (QSR / 21 CFR Part 820).  This includes phased development processes including Concept and Feasibility, Design Inputs, Design Outputs, Design Verification & Validation, Transfer to Manufacturing, etc.  
  • Subject matter expert in the statistics of quality including sample size analysis, power calculations, confidence and reliability, capability analysis, etc.
  • Work closely with cross-functional device development teams as a quality assurance specialist ensuring compliance with company QMS requirements, device Design Control procedures and relevant regulations.
  • Facilitate risk management activities including development of Risk Management Files.  Implements and coordinates Risk Analyses, Failure Modes and Effects Analyses, Fault Tree, Fishbone Diagrams and similar risk assessment and management tools
  • Acts as technical subject matter expert for quality engineering of medical devices representing Medical Device R&D on cross-functional teams including product development teams
  • Refine and update the medical device Quality System to cover all aspects of compliance with medical device and cGMP regulations (21CFR820, EU MDR, ISO 13485, 14971, 10993).  Maintain knowledge of current industry standards and trends in best practices.
  • Work with R&D, Product Engineering and Quality Control to establish acceptance criteria, test methods and related validations to assure product quality.
  • Author R&D/Quality procedures for maintenance/creation of design history files and other supporting documentation.
  • Guide and mentor R&D staff as required.
  • Review and approve R&D/Quality documentation (e.g. Design History Files, Design Control documents, FMEA, Risk Management files, Verification/Validation documentation) 
  • Provide guidance and support to device development team in their verification and validation efforts to ensure compliance.
  • Review and approval of quality issues (e.g. deviation, investigations) and technical matters (e.g. design changes, verification and validation protocols and reports) with impact to design control and risk management.  As required, lead investigations, root cause analyses and CAPAs.
  • Advise technical personnel and management on regulatory compliance related to quality assurance and interpretation and recommend appropriate corrective actions where needed

 

Physical Requirements

0-10% overnight travel required.

 

Qualifications

  • Bachelor's degree required. Degree in a relevant engineering field preferred. Master’s degree preferred
  • 6+ years’ relevant experience required with Bachelor’s degree.  5+ years’ relevant experience with Master’s degree
  • Relevant experience includes:
    • 5+ years of development of class II or class III medical devices
    • Solid experience in product development, especially under Design Controls and for Design Verification & Validation
    • Experience working with Design Controls systems compliant with ISO 13485, MDR, 21 CFR 820 and other relevant regulations
    • Familiarity with medical device standards (e.g. IEC 60601, ISO 10993, ISO 14971, IEC 62366)
    • Preparation and management of Design History Files or equivalent
  • Preferred experience includes
    • Experience with combination product and/or biologics development.
    • Experience mentoring other employees.  
  • Strong track record of managing quality aspects of the development of medical devices, successfully translating concepts to clinical implementation
  • Solid functional knowledge of the statistics of quality as applied to medical device development
  • Understanding of design for manufacturability
  • Thorough understanding of risk assessment, management and mitigation strategies, tools and techniques to ensure positive risk/benefit determinations.
  • Ability to establish sound working relationships.
  • High initiative with the ability to work independently.
  • Detail & deadline oriented; well organized.
  • Flexible.  Demonstrated ability to rapidly adjust to shifting priorities.
  • Excellent verbal and written communication skills.  Able to communicate complex technical subjects to non-technical personnel.
  • Strong interpersonal skills: ability to interact with staff on all levels.
  • Demonstrated critical thinking and problem-solving skills.

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.