Job Details

Payrate: $45.00 - $49.00/hr.

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.
• Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation.
• Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms.

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
• 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.
• Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!

Top 3 Must Have Skill Sets:

• Material & test specs generation, protocol & report writing.
• Process & test development, prototyping, design verification.
• DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.

Nice to have:

• Packaging process experience

Pay Transparency: The typical base pay for this role across the U.S. is: $45.00 - $49.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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