Medical Device Manufacturing Engineer

About the role

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

• Knowledge and experience in Good Documentation Practices (GDP)
• Hands-on experience in planning and executing engineering tests including preparation of test protocols and reports
• Basic knowledge of FDA QSR and requirements for developing and qualifying a medical device

Additional information

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.