1+ months

Staff Mechanical Engineer

Kelly Services
Fremont, CA 94536
If you ask us, this job looks pretty great. Kelly is looking for a **Senior Staff Mechanical Engineer, direct hire position (FTE)** , to work at a clinical-stage biopharmaceutical company enabling the systemic administration of therapeutics and other bioactive molecules to patients using our proprietary intracutaneous microneedle patch system. Be part of a team of industry veterans with proven drug and device development and significant commercialization experience.

**Direct Hire**

**Location** : Fremont, CA

**What you will need for this Senior Staff Mechanical Engineer role:**

+ BS in Mechanical Engineering or a related discipline

+ Minimum 10 years of relevant experience, preferably in the medical device and/or pharmaceutical industry

+ Familiarity with statistical software programs.

+ Outstanding Analytical skills

+ Working knowledge of Solidworks is desirable.

+ Project Management skills are desirable.

+ Willingness to work in a clean room environment and interface with manufacturing personnel.

+ Travel to contract manufacturing sites in NC, AL and MA is required. Approximate amount of travel is 25-40%. Working remotely is a possibility.

+ Authorization to work in the U.S. (Citizen or approved Work Authorization) is required.

**In this Senior Staff Mechanical Engineer role you will:**

+ Provides guidance and oversees manufacturing processes at contract manufacturers.

+ Assists and participates in commissioning and validation of manufacturing processes at contract manufacturers.

+ Represents the company during manufacturing campaigns at contract manufacturers, person-in-plant role.

+ Troubleshoot and investigate process issues and perform process performance optimization.

+ Evaluate process deviation for product and process impact.

+ Track, trend, and analyze in-process data using statistical process control (SPC) methods.

+ Review process analytical data, deviation reports, batch records and other process documents

+ Design, procure and qualify tooling, fixtures, and other equipment to support manufacturing.

+ Maintain schedules and coordinate investigations and activities across functions.

+ Monitor equipment performance. Identify equipment issues and potential solutions.

+ Review specifications, work instructions, protocols, drawings, and reports for technical accuracy.

\#TJP2021_SPEC, #mechanical, #engineer

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

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2021-06-04 Expires: 2021-09-27

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Staff Mechanical Engineer

Kelly Services
Fremont, CA 94536

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