Principal Engineer, Device Manufacturing

Title: Principal Engineer, Device Manufacturing
Reports To: Executive Director, 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 partners/organizations to lead the design, and development of device manufacturing processes.
• Responsible for bridging the gap between Product Development and Manufacturing Engineering. Represent device manufacturing on product development teams.
• Responsible for overseeing Design Transfer, Process Development, Process Validation, Risk Management, and Design for Manufacturing activities at partner organizations.
• 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.
• 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 medical device manufacturing development and clinical/commercial manufacturing
• Requires knowledge of process validation, design for manufacturing, statistics, and lean manufacturing principles.
• Experience with root cause analysis and corrective/preventive action procedures.
• Experience with Lean, Six Sigma, and other best practice tools and principles for problem solving and continuous improvement.
• Prior experience and deep knowledge of cGMPs is required
• Effectively presents technical materials to non-technical people.
• 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
• Knowledgeable of and works within FDA, MDR, ISO, IEC 60601, ISO 14971 and other relevant regulations and standards.

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.