Posted

30+ days ago

Location

Irvine, CA

Description

Reference # :21-00584Title :Product Development Engineer ? Medical Device or Pre-filled Syringe Product Exp. Needed
Location :Irvine, CA
Position Type :Contract
Experience Level :Start Date / End Date :03/29/2021 / 03/28/2022 
Description

PRODUCT DEVELOPMENT ENGINEER ? MEDICAL DEVICE OR PRE-FILLED SYRINGE PRODUCT EXP. NEEDED
IRVINE, CA



Project Description:

  • Test method development and validation; investigation of clinical observations; design feasibility assessment; verification testing; documentation of performed tests, analysis etc.

  • Further, employee in this position will be working with vendors (both manufacturing and development partners).

  • The time is split between lab and desk, ~50/50.

  • The candidate may present the functional group in Device sub-teams.

  • Has performed tolerance stack up analysis and uses Solid Works daily.

  • Has experience performing root cause analysis; is familiar with FDA rules regulating the medical device and combination product development.

  • Has used elements of design controls and risk management in design development.

  • The candidate has been a part of development team and works well in cross-functional teams; understands basic principles of molded plastic part design and is familiar with conventional manufacturing technologies.

  • Has a track record of managing outsourced development efforts; is able to travel up to 10% of the time.

  • Under minimal direction, the Senior Engineer will perform engineering duties associated with the design, research, and development of combination products.

  • He/she generates and reviews development documentation; provides technical assessments for business development decisions as needed; provides technical solutions to a wide range of difficult and complex problems.

  • Will represent the organization as the prime technical contact on contracts and projects and interact with senior external personnel on significant technical matters, often requiring coordination between organizations.


Required Skills:

  • B.S. Engineering or other related discipline with 7+ years of experience OR M.S. with 5+ years of experience. Advanced degree desired.

  • Design Controls and Risk Management experience - from early stages to validation and transfer.

  • Experience in combination products including a biologic (filling, packaging, sterilization).

  • Pre-filled syringe development experience; Knowledge of GMPs, ISO standards related to the pre-filled syringes development and manufacture.

  • Demonstrated knowledge of research and development aspects from product concept to product launch, including design and process development, vendor communication, protocol creation, design, testing and documentation.

  • Complete understanding and application of technical principles, theories, and concepts in the field of parenteral delivery.

  • Experience working in a general engineering laboratory setting common for medical device development.

  • Ability to comprehend and apply principles of advanced math and statistical theory (to include t-tests, f-tests, tolerance limits, sample size determination, etc.).

  • Ability to effectively interact with CMOs to transfer designs into production.

  • Software:

    • SolidWorks

    • Minitab

    • MS Office Suite

  • In addition to the above requirements, the following are desired skills/experiences:

    • Statistical tools: DOE, ANOVA

    • Experience with usability engineering requirements, and usability specifications

    • Numerical methods: FEA

    • Authoring sections in regulatory submissions

    • Software: Matlab, Labview, MS Project


This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Kristine: kristine@alphaconsulting.com

ALPHA'S REQUIREMENT #21-00584
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

#ZR

#LI-KN1

About the Company

Alpha Consulting Corp.

Our goal, in addition to communicating the benefits of becoming associated with Alpha Consulting, is to provide news, opinions, and resources to assist Clients and Consultants. As with our careers, the content will continuously change and evolve over time.

Alpha Consulting Corporation is an IT (Information Technology) staffing business specialty with the ability to understand your specific project requirements and promptly supply appropriately matched consultants to fill both short and long-term client needs.

Company Size

100 to 499 employees

Industry

Staffing/Employment Agencies

Founded

1994

Website

http://www.alphaconsulting.com/