Principal Device Engineer/Associate Director, Device Engineering

Title:                                    Principal Device Engineer / Associate Director, Device Engineering
Reports To:                         Executive Director, & Head of Device Engineering
Location:                             Redwood City, California
Classification:                    Exempt 

Overview:

An Individual contributor role focusing on development and commercialization of drug-device combination products, sustaining engineering, and 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
• Author and review drug-device combination product regulatory submissions
• Act as a device subject matter expert during regulatory agency interactions and partner audits
• Oversee device CMOs and testing laboratories to ensure successful clinical and commercial GMP production and testing 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
• Provide hands-on troubleshooting, process, and engineering assistance in support of a rapid development cycle
• Provide technical support to on-market design changes, change control impact assessments, complaint trending, CAPA, and post-market risk management activities throughout product lifecycle
• 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)
• Work closely with CMOs and testing laboratories and 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
• 6-8 years of relevant experience industry experience in delivery device design & development and clinical/commercial manufacturing
• Strong background in engineering of electro-mechanical and disposable medical devices is required
• Must have experience in developing drug-device combination products
• Must have experience with industry standard design and development tools (CAD, math modeling, tolerance analysis, and statistical software)
• Prior experience and deep knowledge of cGMPs is required
• Complete knowledge of Quality System Regulation, including Design Controls is required
• 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 familiarity with the following standards:
  • 21CFR820 Quality System Regulation
  • ISO 14971 Risk Management
  • ISO 11608 series Needle based injection systems
  • EN 60601 Medical Electrical Equipment

The Base Salary Range for this position is $165,000 - $190,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

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.