"Alerted.org

Duration: 12 months contract

**Shift:** Regular Working Hours

Job Description:

Lead 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 Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Job Responsibilities:

+ Work cross-functionally with individuals and project teams in Marketing, Operations, and Development

+ Create and assess product requirements to determine technical coverage and proper integration different subsystems.

+ Create and 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 deep technical assistance for junior engineers.

Skills:

+ BS in Engineering and previous experience in a medical device industry

+ 10 years current experience with engineering processes and procedures.

+ Led projects from development through the 510k and PMA approval process.

+ 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) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.

+ Experience in drug/device combination product design and development

+ Familiar with the following standards: o Quality System Regulation ? 21CFR820 o Risk Management ? ISO 14971 o EU Medical Device requirements ? Council Directive 93/42/EEC o Medical Electrical Equipment ? EN 60601

+ Small scale device assembly experience.

+ Ability to read, analyze, and interpret general business periodicals, professional journals, 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.

Basic Qualifications:

+ Doctorate degree and 3 years of experience OR

+ Masters degree and 5 years of experience OR

+ Bachelors degree and 7 years of experience OR

+ Associates degree and 12 years of experience OR

+ High school diploma / GED and 14 years of experience

Very Important Note:

+ Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Engineering background need to apply and will be considered!!!

Must Have Skill Sets:

+ Develop, execute, and design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.

+ 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) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.

+ Strong problem solving, risk assessment, and risk management skills and capable of working on multiple projects in a deadline driven environment.

Day to Day Responsibilities:

+ 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. In addition to troubleshoot new equipment to be implemented.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"