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26 days old

Product Engineer, Medical Devices, Pharmaceuticals

Kelly Services
San Dimas, CA 91773
**Product Engineer, Medical Devices, Pharmaceuticals in San Gabriel Valley, CA**


This position will serve as the technical liaison from product development to Manufacturing and Regulatory Affairs. The position performs a vital part in enhancing the Companys infrastructure and has the capability to contribute to the strength and sustainable growth of our client.


**Responsibilities**


+ Develop, maintain and drive Risk Management activities in collaboration with the Quality and Regulatory teams in accordance with FDA, ISO 14971:2019, and Medical Device Regulation (MDR) requirements

+ Write annual medical device and drug reviews

+ Perform GAP Analysis on new international standards

+ Contribute to development of regulatory filings and submissions such as technical files

+ Perform and write validations of products, processes, and equipment in accordance with FDA, EU, and ISO guidelines

+ Develop testing methods and protocols

+ Serve as a subject matter expert for all product questions (to address technical file audits, registrations, submissions, etc.)

+ Adhere to general safety rules, manufacturing procedures, and quality procedures as applicable

+ Exhibit professional behavior and demeanor at all times; proactively resolve issues using Best Practices


**Skills & Qualifications**


+ Bachelors Degree in Biomedical Engineering, Chemical Engineering, Materials Science Engineering or Mechanical Engineering or equivalent from an accredited institution required;

+ Masters Degree in Engineering (MSE) preferred

+ Ten (10) plus years of experience in the medical device or pharmaceutical industry

+ Excellent computer skills; Adept in use of Microsoft Office

+ Creative in approaching technical challenges and creating solutions with various approaches

+ Excellent written and verbal communication skills

+ Able to draw on diplomatic communication skills

+ Work well independently and as a team member

+ Able to maintain detailed records and technical documentation

+ Organized and able to work in a time-sensitive environment prioritizing and managing multiple assignments


Fast track the process and apply today! Qualified talent will be contacted within 24 hrs.


**If youre unable to apply through the website, please email your resume in Word format and position title to JEND557@kellyscientific.com.**


_Kelly Science & Clinical is the premier destination for Scientific Professionals seeking Direct-Hire, Temp-to-Hire, and Contract positions across the country. Scientific Recruiters are ready to select and represent the best candidates to join their award winning scientific clients._


\#TJP2021_SPEC


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-04-12 Expires: 2021-05-13

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Product Engineer, Medical Devices, Pharmaceuticals

Kelly Services
San Dimas, CA 91773

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