Job Description

Job Title: Senior Engineer/ Engineer Principal

Location: New Albany, OH

Duration: 12+ Months

Description

Onsite AOH - Monday - Friday - Standard 8-5

Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month.

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 qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices.

The Principal 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 Principal Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

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.

VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!

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