3 Key Consulting, Inc.

Engineer Senior, Drug Delivery Medical Device - (JP9675)

3 Key Consulting, Inc.  •  Thousand Oaks, CA (Onsite)  •  1 month ago
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Job Description

Job Title:   Engineer Senior, Drug Delivery Medical Device - (JP9675)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: Mechanical Autoinjectors Platform
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 1/13/2022
Notes:

3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.


Support the teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will support technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Sr. Engineer will work closely with device Subject Matter Expert (SME) to support develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Sr. Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Responsibilities include:
  • Work cross-functionally with individuals and project teams in Quality, Operations, and Development.
  • Create and assess product requirements to determine technical coverage and proper integration different subsystems.
  • Execute to project plans and schedules.
  • Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
  • Provide technical assistance for junior engineers.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:
1. 5 years min experience in device engineering end to end configuration control management
2. Design characterization, verification execution.
3. Device design experience(design for six sigma experience a +)

Day to Day Responsibilities:
Support and manage day to day commercial advancement operation to ensure deliverables and deadlines are met. Coordinate activities and provide guidance to jr. engineers

Basic Qualifications:
  • BS in Engineering and previous experience in a medical device industry.
  • 10 years current experience with engineering processes and procedures.
  • Strong background in engineering and commercialization of electro-mechanical medical devices.
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
  • Product design/development (design control).
  • Experience in drug/device combination product design and development.
  • Familiar with the following standards:
    • Quality System Regulation 21CFR820 - Risk Management; ISO 14971 - EU Medical Device requirements; Council Directive 93/42/EEC - Medical Electrical Equipment; EN 60601 - Small scale device assembly experience.
  • Ability to read, analyze, and interpret general technical procedures, or governmental regulations.
  • Strong problem solving, risk assessment, and risk management skills.
  • Must be capable of working on multiple projects in a deadline driven environment.
  • VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems Engineering background need apply and will be considered!!!

Employee Value Proposition:
Great biotech/pharma to work for.

Red Flags:
Applicants without 5 years of experience with one company.

Interview process:

Video Skype Panel Interview

We invite qualified candidates to send your resume to  resumes@3keyconsulting.com  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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