Job Description

Ultimate Staffing is hiring a Manufacturing Engineer to support a great medical device manufacturing company located in Sunnyvale, CA.

SUMMARY
This position will support the Operations, Research and Development and Quality/Regulatory groups with verification and validation activities.  This position is also is responsible for all verification activities and supports validation efforts for medical devices, instrumentation, chemistry strips, software, and supporting manufacturing processes.  Additionally, this position will assist in the verification and validation activities for equipment and process including writing and execution, design and development control, FDA GMP and EU IVDDs and regulatory and quality compliance.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develop, write and execute medical device system verification and validation protocols and scripts.  Includes medical device instruments, software, and chemistry strips used in whole-blood analysis, as well as process validations. 
• Develop, write and execute equipment and/or facility qualification protocols, such as IQ, OQ and PQ to support operations and manufacturing departments
• Generating verification and validation report summaries and logging issues.
• Review and approval of engineering change requests.
• Utilize issue tracking software.
• Support verification and validation activities related to the Cotinine product line 
• Be a representative of the company during supplier audits as needed
• Ensure the verification and validation process is a streamlined process while still adhering to all regulatory and quality compliance requirements.
• Assist in audits as required.
• Additional duties as assigned.

 
QUALIFICATIONS

• Ability to drive projects to timely completion.  
• Adept at interfacing with various disciplines in a company.
• Strong attention to detail.
• Working knowledge of product, equipment, and process validation in the medical device sector.
• Working knowledge of the medical device IVDD business
• Understanding of the role of QA and QC in the medical device business.
• Ability to work in a team environment and individually with little guidance.
• Strong knowledge of applicable FDA, EU, and ISO 13485 regulations.
• Strong understanding and knowledge of quality standards and validation regulations within the medical devices sector.

 
EDUCATION and/or EXPERIENCE

• Bachelor of Science degree in Engineering, Biology, Chemistry or related area of study from an accredited four-year college or university. preferred
• 3-5 years related experience and/or training in the medical device or closely related industry is required.
• Experience with process and equipment validation is required.
• Experience with in vitro diagnostics is preferred.

 
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
Ability to work inside a laboratory and typical office environments.
 

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
To apply please email your resume to dvanderpool@ultimatestaffing.com

Job Snapshot

• Employee Type:Full-Time
• Location:Sunnyvale, CA
• Job Type:Manufacturing
• Experience:Not Specified
• Education:Not Specified
• Date Posted:9/25/2023
• Contact: Danielle Vanderpool (408) 436-3031
• Pay Range: $115,000.00 - $130,000.00 Annually

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