Director, Device Engineering

Location
Redwood City, California
Posted
Jun 27, 2022
Ref
4186801
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Title:                                    Director, Device Engineering
Reports To:                        
Executive Director, Device Engineering
Location:                             Redwood City, California
Classification:                    Exempt 

Overview:

Developing and commercializing drug-device combination products and providing lifecycle manufacturing support.

Essential Duties and Job Functions:

  • Work with device development organizations to ensure device development activities including design development, verification, validation, risk management, process validation, and human factors studies are executed per device regulations and applicable standards
  • Work closely with drug product development teams to ensure that primary container process capabilities are taken into consideration in device design and that primary containers are specified appropriately to meet device design requirements
  • Support drug-device combination product regulatory submissions
  • Act as a subject matter expert during regulatory agency interactions and partner audits
  • Oversee CMOs to ensure successful clinical and commercial GMP production of drug-device combination products
  • Provide technical support to resolve manufacturing deviations, conduct complaint investigations, implement corrective actions, review ongoing process monitoring and process improvements
  • Support the quality organization in planning and execution of stability studies
  • Manage projects from inception to commercialization
  • Travel as required to suppliers and manufacturing sites located around the world
  • Coordinate and attend kick-off meetings with CMOs and device organizations
  • Provide on-site support for trouble shooting and investigations
  • Author/review design control documents (i.e., DHF documents) to support device development deliverables (design development plans, design inputs, design outputs, design transfers, protocols, reports, risk management, design validation, design transfer)
  • Provide technical input for device testing (e.g. method development and validation, fixture review) 

Knowledge, Experience and Skills:

  • Requires a BS/MS degree in engineering or a related scientific field
  • 10-14 years of relevant experience industry experience in delivery device design & development and clinical/commercial manufacturing
  • Must have experience developing drug-device combination products
  • Prior experience and deep knowledge of a cGMPs is required
  • Knowledge of applicable Quality and Regulatory guidelines
  • Experience with guiding GMP investigations at contract vendors
  • Must work well in cross-functional teams and be able to communicate effectively with external partners, peers, and senior management
  • Must have prior experience managing third-party relationships
  • Must have strong negotiating and interpersonal skills, and the ability to clearly present recommendations
  • Must have excellent decision-making, leadership, interpersonal, verbal and written communication skills
  • Must have strong computer skills, including all MS Office applications
  • Must have experience with industry standard design and development tools (CAD, math modeling, tolerance analysis, and statistical software)

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.