Principal Device Engineer/Associate Director, Device Engineering
Company: Coherus BioSciences
Location: Redwood City
Posted on: January 22, 2023
Job Description:
Title: Principal Device Engineer / Associate Director, Device
Engineering Reports To: Executive Director, & Head of Device
EngineeringLocation: 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.
Keywords: Coherus BioSciences, Redwood City , Principal Device Engineer/Associate Director, Device Engineering, Engineering , Redwood City, California
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