Job 08-008
Medical Device Hardware Engineer
Summary & Scope of Position
Successful candidate will be responsible for the development and product support activities for the instrument hardware of the INTERCEPT Blood system Illuminator. Candidate will develop engineering solutions for new instrument, and work with partners and contract manufacturers to support current product hardware and operational needs in the EU and US.
Primary Responsibilities:
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Evaluate existing alternatives, customer needs, and total design space and translate into new instrument design & development or commercial instrument upgrade implementations.
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Design and develop solutions to current GMP regulations and ISO standards, including verification and validation activities.
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Perform troubleshooting on commercial products/process problems as related to design, components, or process.
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Explore engineering alternatives for instrument upgrades, electronic troubleshooting/component replacement.
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Revise and implement proposals for new product specifications or current specification modification (ECO system).
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Design, document, and coordinate instrument electrical and mechanical experiments (DOE), qualifications, validations, and functional tests.
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Summarize, analyze, and draw conclusions from results.
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Contribute as a member on cross functional product development teams - work cooperatively with development, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
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Demonstrate product development process system knowledge through delivery of high quality results.
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Operate independently to plan and schedule activities necessary to meet timelines.
Qualifications/Requirements/Skills:
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BS or MS in Electrical or Mechanical Engineering with a minimum of 5 years related engineering experience.
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Minimum of 5 years experience with medical instruments required.
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Experience in QSRs and design control for medical instrument environment to meet GMPs / ISO 13485 and 21 CFRs / validations.
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Experience implementing testing to verify conformance to EN 61000 and ASTM standards.
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Comfortable in the hardware/software interface; reading schematics and understanding interfaces with peripheral devices.
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Practical experience, solid understanding of electrical principles, testing and manufacturing processes.
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Excellent problem solving and trouble-shooting skills.
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Excellent computer networking ability.
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Familiar with the use of all common electronic test equipment including Digital Multi-Meters, oscilloscopes and safety analyzers.
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Strong communication skills; including ability to write clear and concise technical procedures and reports.
- Demonstrated success in working with suppliers and contract manufacturers.
How to Apply
Interested Candidates may submit a resume by one of the following methods.
By Mail:Cerus Corporation
Attn: Human Resources
2411 Stanwell Dr.
Concord, CA 94520 |
By Fax:
925-288-6090 |
Online:hr@cerus.com |
For Staffing VendorsCerus does not accept unsolicited resumes from staffing vendors, including recruitment agencies and/or search firms, nor does Cerus pay fees to any such vendors without a current agreement on file. Please do not contact or solicit Cerus hiring managers regarding these matters.
Equal Opportunity Employer
Cerus Corporation is proud to be an equal opportunity employer and extends employment to men and women from culturally diverse backgrounds. We respect and value individual differences and recognize each employee as an integral member of our company. Our work force reflects these values and celebrates the individuals who make up our growing team.
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