Medical Device Manufacturing Engineer

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Skills:
BS in Mechanical Engineering and previous experience in a medical device, or similar industry, with 2 - 6 years current experience with engineering processes and procedures.
Participation in development projects from concept through the 510k and PMA approval process.
Strong background in engineering of electro-mechanical and disposable medical devices.
Ability to model and analyze mechanical systems, fluid flow, stress, assemblies, structures, linkages, heat transfer and other mechanical engineering specialties.
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.

Familiarity with the following standards:
21CFR820 Quality System Regulation
ISO 14971 Risk Management
EU Medical Device requirements
Medical Devices Directive 93/42/EEC
Medical Electrical Equipment
EN 60601

Top 3 Skill Sets:

1. Knowledge and experience in Good Documentation Practices (GDP)

2. Hands-on experience in planning and executing engineering tests including preparation of test protocols and reports

3. Basic knowledge of FDA QSR and requirements for developing and qualifying a medical device

Support project 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 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 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 within project teams.
Create and assess product requirements to determine technical coverage and proper integration different subsystems.
Perform design analyses and assessments.
Execute design characterization and design verification testing.
Develop, execute, and review design documents, specifications, development plans, characterization plan, verification plans, reports, and other related product development documents for assigned projects.
Provide technical assistance to projects.

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.
Plastic part design experience is a plus.

BS in Mechanical Engineering and previous experience in a medical
device, or similar industry, with 2 - 6 years current experience with
engineering processes and procedures.
Participation in development projects from concept through the 510k and PMA approval process.
Strong background in engineering of electro-mechanical and disposable medical devices.

1. Knowledge and experience in Good Documentation Practices (GDP)

2. Hands-on experience in planning and executing engineering tests including preparation of test protocols and reports

3. Basic knowledge of FDA QSR and requirements for developing and qualifying a medical device