Job Description

• Individual must have background with data analysis.
• Ability to receive, validate and manipulate those reports.
• Excellent technical writing skills.
• Prefers a Masters in Engineering and 3 YOE.
• Must have experience in a GMP environment.
• Needs to have Biotech/Pharma/ Med Device exp.

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

• Technical writing skills-experience in writing on owning GMP documents and records.
• Oversight and management of multiple projects and tasks for 3rd party suppliers.
• Data analysis to develop insights and strategies.

• Management of 3rd party supplier ensuring Quality Agreement is adhered to Quality record ownership.
• Tracking of key metrics and performance indicators.
• 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 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.

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR
• Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
• 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.

• Extensive job history within short period of time
• No experience in GMP working environment