Principal Engineer, Device Manufacturing
Company: Coherus Biosciences Inc
Location: Redwood City
Posted on: May 17, 2023
Title: Principal Engineer, Device Manufacturing Reports To:
Executive Director, Device EngineeringLocation: Redwood City,
CaliforniaClassification: Exempt -
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
- 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
- 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
- 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
- 6-8 years of relevant experience industry experience in medical
device manufacturing development and clinical/commercial
- Requires knowledge of process validation, design for
manufacturing, statistics, and lean manufacturing
- Experience with root cause analysis and corrective/preventive
- Experience with Lean, Six Sigma, and other best practice tools
and principles for problem solving and continuous
- Prior experience and deep knowledge of cGMPs is
- Effectively presents technical materials to non-technical
- Experience with guiding GMP investigations at contract
- Must work well in cross-functional teams and be able to
communicate effectively with external partners, peers, and senior
- Must have prior experience managing third-party
- 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
- 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. -
Keywords: Coherus Biosciences Inc, Redwood City , Principal Engineer, Device Manufacturing, Engineering , Redwood City, California
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