SanMateoRecruiter Since 2001
the smart solution for San Mateo jobs

Senior Engineer

Company: AllSTEM
Location: San Mateo
Posted on: October 14, 2020

Job Description:

AllSTEM Connections is looking for a Senior Engineer for a Direct Hire position. This role will be developing and commercializing drug-device combination products and providing life cycle manufacturing support. Essential Duties and Job Functions bull Drug-device combination product development and commercialization bull 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 industry standards bull Work closely with drug product process development teams to ensure that filling and stoppering process capabilities are taken into consideration in device design and prefilled syringes are consistently manufactured to meet device design requirements bull Lead device assembly equipment selection, qualification and process validation bull Support drug-device combination product regulatory submissions bull Act as a subject matter expert during regulatory agency interactions and partner audits bull Oversee CMOs to ensure successful clinical and commercial GMP production of drug-device combination products bull Provide technical support to resolve manufacturing deviations, conduct complaint investigations, implement corrective actions, review ongoing process monitoring and process improvements bull Support quality in device stability planning bull Manage projects from inception to commercialization bull Travel as required to suppliers and manufacturing sites located around the world bull Coordinate and attend kick-off meetings with CMOs and device organizations bull Provide on-site support for trouble shooting and investigations Knowledge, Experience and Skills bull Requires a BSMS degree in engineering or a related scientific field bull 5-8 years of relevant industry experience in delivery device design development and clinicalcommercial manufacturing bull Must have experience developing drug-device combination products bull Prior experience and deep knowledge of a cGMP related industry is required, within the Biopharmaceutical or Pharmaceutical industry bull Must have knowledge of applicable Quality and Regulatory guidelines bull Must have experience with guiding GMP investigations at contract vendors bull Must work well in cross-functional teams and be able to communicate effectively with external partners, peers, and senior management bull Prior experience managing third party relationships bull Must have strong negotiating and interpersonal skills, and the ability to clearly present recommendations bull Excellent decision-making, leadership, interpersonal, written and verbal communication skills bull Must have strong computer skills, including all MS Office applications bull Must have experience with industry standard design and development tools (CAD, math modeling, tolerance analysis, and statistical software)

Keywords: AllSTEM, San Mateo , Senior Engineer, Other , San Mateo, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Class A OTR Driver
Description: Class A OTR Driver - Dedicated Account Home Daily Class A Drivers Home Daily working 5 days on and 2 consecutive days off Drivers will run WA and N. OR with average driver earning 76K/1st year (more...)
Company: CLASS A TRUCKIN
Location: Woodland
Posted on: 10/23/2020

Medical Assistant
Description: Overview: Dignity Health Medical Foundation, established in 1993, is a California nonprofit public benefit corporation with care centers throughout California. Dignity Health Medical Foundation is an (more...)
Company: Woodland Clinic Medical Group
Location: Woodland
Posted on: 10/23/2020

Site Reliability Engineer
Description: Join Hired and find your dream job as a DevOps Engineer/SRE at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. You'll receive (more...)
Company: Hired
Location: Woodland
Posted on: 10/23/2020


Recent Grad CDL-A Truck Driver - Refrigerated, Safest in Trucking!
Description: Job Description: 10 10 Recent CDL-A Grads: Don 38 amp 39 t have enough experience to get the truck driving job you want No worries, come join
Company: C.R. England
Location: Woodland
Posted on: 10/23/2020

Junior Financial Representative
Description: We're More Than Insurance At Mutual of Omaha, we're not afraid to step outside the box and release the potential for ultimate success. We are a Fortune 500 company that allows you to carve your own professional (more...)
Company: Mutual of Omaha
Location: Woodland
Posted on: 10/23/2020

DevOps Engineer
Description: Join Hired and find your dream job as a DevOps Engineer at one of 10,000 companies looking for candidates just like you. Companies on Hired apply to you, not the other way around. You'll receive (more...)
Company: Hired
Location: Woodland
Posted on: 10/23/2020

Membership Assistant
Description: Costco Wholesale Corp. - 2299 BRONZE STAR DRIVE Customer
Company: Costco Wholesale Corp.
Location: Woodland
Posted on: 10/23/2020

Lyft Driver (No Experience Needed)
Description: Earn 2,500 in Sacramento when you give 200 rides in 30 days. Terms apply. 10 What is Lyft 10 Lyft is a platform that connects drivers with individuals and organizations that need rides. 10 In addition (more...)
Company: Lyft
Location: Woodland
Posted on: 10/23/2020

FedEx - Warehouse Pro
Description: Job Description: 10 10 Auto req ID: 253882BR Job Summary FedEx Ground is an essential business that needs people to help us support the economy, handling life-saving medications and other items that (more...)
Company: FedEx Ground PH US
Location: West Sacramento
Posted on: 10/23/2020

Refrigerated Truck Driver CDL-A Recent Grads - Delivery Food and Supplies!
Description: Job Description: 10 10 Recent CDL-A Grads: Don 38 amp 39 t have enough experience to get the truck driving job you want No worries, come join
Company: C.R. England
Location: Woodland
Posted on: 10/23/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Mateo RSS job feeds