Engineer Principal

Engineer Principal

Top 3 Must Have Skill Sets:

The Principle Engineer will work closely with team members to focus on the following skills:

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.

Red Flags:

Flexibility to work off hours or extended days occasionally.

Summary:

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 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.

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:

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 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 Engineering background need apply and will be considered!

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

Pay range is $43 - $48 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.

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